Feasibility of Parent Training via Telehealth for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot
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| Title: | Feasibility of Parent Training via Telehealth for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot |
|---|---|
| Language: | English |
| Authors: | Bearss, Karen, Burrell, T. Lindsey, Challa, Saankari A., Postorino, Valentina, Gillespie, Scott E., Crooks, Courtney, Scahill, Lawrence |
| Source: | Journal of Autism and Developmental Disorders. Apr 2018 48(4):1020-1030. |
| Availability: | Springer. 233 Spring Street, New York, NY 10013. Tel: 800-777-4643; Tel: 212-460-1500; Fax: 212-348-4505; e-mail: service-ny@springer.com; Web site: http://www.springerlink.com |
| Peer Reviewed: | Y |
| Page Count: | 11 |
| Publication Date: | 2018 |
| Sponsoring Agency: | National Institute of Mental Health (DHHS/NIH) National Center for Advancing Translational Sciences (NCATS) (DHHS/NIH) |
| Contract Number: | MH081148 UL1TR000454 |
| Document Type: | Journal Articles Reports - Research |
| Education Level: | Adult Education |
| Descriptors: | Parents, Pervasive Developmental Disorders, Autism, Rural Areas, Young Children, Parent Education, Outcome Measures, Feasibility Studies, Pilot Projects, Student Behavior, Behavior Problems, Access to Health Care, Telecommunications, Health Services, Allied Health Personnel, Outcomes of Treatment |
| DOI: | 10.1007/s10803-017-3363-2 |
| ISSN: | 0162-3257 |
| Abstract: | Telehealth is a potential solution to limited access to specialized services for children with autism spectrum disorder (ASD) in rural areas. We conducted a feasibility trial of parent training with children ages 3-8 with ASD and disruptive behavior from rural communities. Fourteen children (mean age 5.8 ± 1.7) from four telehealth sites enrolled. Thirteen families (92.9%) completed treatment, with 91.6% of core sessions attended. Therapists attained 98% fidelity to the manual and 93% of expected outcome measures were collected at week 24. Eleven of 14 (78.6%) participants were rated as much/very much improved. Parent training via telehealth was acceptable to parents and treatment could be delivered reliably by therapists. Preliminary efficacy findings suggests further study is justified. |
| Abstractor: | As Provided |
| Number of References: | 45 |
| Entry Date: | 2018 |
| Accession Number: | EJ1173373 |
| Database: | ERIC |
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| FullText | Links: – Type: pdflink Url: https://content.ebscohost.com/cds/retrieve?content=AQICAHj0k_4E0hTGH8RJwT4gCJyBsGNe_WN95AvKlDbXJGqwxwEhw64Bzgy4J_yWq3NyaXVcAAAA4zCB4AYJKoZIhvcNAQcGoIHSMIHPAgEAMIHJBgkqhkiG9w0BBwEwHgYJYIZIAWUDBAEuMBEEDJ1V2vcwvpt_G7j0JgIBEICBm2zdA2fqIpvF863m8b76Auo1pp5pteBm4F5Baz8SKr-IuMV-y3kOB5KjjN07X-lStFptGoTSlynfxotzTHdt3osrtGOXxbejQOXB2p_ihNDH8FNAQ2E4vfBCs4z9q0yTgRBnMfIAFsCKgn0qd5d4StdFPf2aNO2yDUh9jFYJz2pSg-ZQFBEvEvsqaNXzAB5p7Ykyl6uX1rV26uvA Text: Availability: 1 Value: <anid>AN0128597951;aut01apr.18;2018Mar22.12:26;v2.2.500</anid> <title id="AN0128597951-1">Feasibility of Parent Training via Telehealth for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot </title> <p>Telehealth is a potential solution to limited access to specialized services for children with autism spectrum disorder (ASD) in rural areas. We conducted a feasibility trial of parent training with children ages 3-8 with ASD and disruptive behavior from rural communities. Fourteen children (mean age 5.8 ± 1.7) from four telehealth sites enrolled. Thirteen families (92.9%) completed treatment, with 91.6% of core sessions attended. Therapists attained 98% fidelity to the manual and 93% of expected outcome measures were collected at week 24. Eleven of 14 (78.6%) participants were rated as much/very much improved. Parent training via telehealth was acceptable to parents and treatment could be delivered reliably by therapists. Preliminary efficacy findings suggests further study is justified.</p> <p>Autism spectrum disorder; Parent training; Disruptive behavior; Telehealth</p> <hd id="AN0128597951-2">Introduction</hd> <p>Autism spectrum disorder (ASD) is a chronic neurodevelopmental condition of early childhood onset characterized by social communication deficits, restricted interests and repetitive behaviors (American Psychiatric Association (APA) [<reflink idref="bib3" id="ref1">3</reflink>] ). ASD affects an estimated 6-14 per 1000 children and is a major public health challenge (Center for Disease Control and Prevention (CDC) [<reflink idref="bib8" id="ref2">8</reflink>] ; Elsabbaugh et al. [<reflink idref="bib14" id="ref3">14</reflink>] ). A recent National Health Statistics report indicated a steady rise in the number of children diagnosed with ASD and an increased demand for services (Zablotsky et al. [<reflink idref="bib45" id="ref4">45</reflink>] ). Availability of empirically supported behavioral interventions, however, has not kept pace.</p> <p>One of the barriers to implementation of empirically supported interventions is the lack of trained specialists—especially in rural and underserved areas (Belfer and Saxena [<reflink idref="bib6" id="ref5">6</reflink>] ; World Health Organization [<reflink idref="bib44" id="ref6">44</reflink>] ). The limited access to effective behavioral treatment often results in long delays and additional travel costs for families to obtain services from centers with appropriate expertise (Wacker et al. [<reflink idref="bib40" id="ref7">40</reflink>] , [<reflink idref="bib41" id="ref8">41</reflink>] ). Telehealth (also known as ‘telepractice’ or ‘telemedicine’) uses communication technologies (e.g., computer-based videoconferencing and the internet) that allow specialists to consult or deliver services in real-time over a geographical distance (Dudding [<reflink idref="bib13" id="ref9">13</reflink>] ). Increasing the availability of empirically-supported, time-limited and cost-effective interventions for children with ASD through the use of telehealth may be a way to close the gap between service demand and availability in rural and underserved areas. The application of these technologies to deliver health services across a range of conditions is growing at a rapid pace, with services increasingly migrating from hospitals and satellite clinics to the home and mobile devices (Dorsey and Topol [<reflink idref="bib12" id="ref10">12</reflink>] ).</p> <p>Despite these developments, the use of telehealth specifically for the assessment and treatment of children with ASD is underdeveloped. A 2010 review of the use of telehealth in the assessment and treatment of individuals with ASD identified only eight peer-reviewed papers, largely single subject designs (Boisvert et al. [<reflink idref="bib7" id="ref11">7</reflink>] ). More recently, Wacker et al. provided functional communication training (FCT) via telehealth and showed that it is acceptable to parents and promising for reducing behavior problems in children with ASD (Lindgren et al. [<reflink idref="bib23" id="ref12">23</reflink>] ; Suess et al. [<reflink idref="bib37" id="ref13">37</reflink>] ; Wacker et al. [<reflink idref="bib40" id="ref14">40</reflink>] , [<reflink idref="bib41" id="ref15">41</reflink>] ). Ingersoll et al. piloted telehealth delivery of Project ImPACT (called ImPACT Online), which is designed to teach parents how to promote their child’s social-communication development during play and daily routines (Ingersoll and Berger [<reflink idref="bib18" id="ref16">18</reflink>] ; Ingersoll et al. [<reflink idref="bib19" id="ref17">19</reflink>] ; Pickard et al. [<reflink idref="bib29" id="ref18">29</reflink>] ; Wainer and Ingersoll [<reflink idref="bib42" id="ref19">42</reflink>] ). Finally, parent-mediated Early Start Denver Model has also been evaluated using two-way video conferencing in the parents’ homes (P-ESDM; Vismara et al. [<reflink idref="bib39" id="ref20">39</reflink>] , [<reflink idref="bib38" id="ref21">38</reflink>] ). These studies support the promise of telehealth as an effective treatment modality for core symptoms and co-occurring challenging behaviors in individuals with ASD.</p> <p>The Research Unit on Behavioral Interventions (RUBI) Autism Network developed a structured Parent Training (PT) program targeting common behavioral problems such as tantrums, noncompliance, and aggression in children with ASD (Hartley et al. [<reflink idref="bib16" id="ref22">16</reflink>] ; Mazurek et al. [<reflink idref="bib27" id="ref23">27</reflink>] ). These behaviors interfere with performance of daily living skills, limit the child’s ability to benefit from educational and habilitative services, and may increase social isolation (Maskey et al. [<reflink idref="bib26" id="ref24">26</reflink>] ; Scahill et al. [<reflink idref="bib34" id="ref25">34</reflink>] ). Uncertainty on how to manage these behavioral problems may also amplify caregiver stress (Hayes and Watson [<reflink idref="bib17" id="ref26">17</reflink>] ; Lecavalier et al. [<reflink idref="bib21" id="ref27">21</reflink>] ). In a prior multisite randomized trial we showed that PT was superior to parent education in reducing disruptive behavior in young children with ASD when delivered in specialty clinical settings by trained therapists (Bearss et al. [<reflink idref="bib5" id="ref28">5</reflink>] ).</p> <p>RUBI-PT delivered via telehealth has the potential to expand the pool of available service options for families of children with ASD residing in rural and underserved areas, with its unique targets for intervention as well as its potential to be delivered by a broad range of clinicians. For example, whereas Vismara et al. ([<reflink idref="bib39" id="ref29">39</reflink>] ) and Ingersoll and colleagues ([<reflink idref="bib19" id="ref30">19</reflink>] ) focus on treatments for core symptoms of ASD, RUBI-PT targets commonly seen co-occurring maladaptive and disruptive behaviors. Wacker et al. ([<reflink idref="bib40" id="ref31">40</reflink>] , [<reflink idref="bib41" id="ref32">41</reflink>] ) similarly target disruptive behaviors using the tailored approach of functional analysis and functional communication training (FCT). RUBI-PT, conversely, takes a skills-based approach by teaching parents an array of behavioral strategies (e.g., antecedent management, reinforcement, compliance training) designed to target a range of behavioral issues as well as skill deficits (e.g., toileting, feeding, and sleep issues). Finally, FCT involves treatment delivered by clinicians with specialized training in principles of applied behavior analysis. RUBI-PT, in comparison, is a highly structured intervention that has been successfully delivered by a broad range of practitioners (e.g., psychologists, speech pathologists, child psychiatrists, nurse practitioners, graduate-level trainees).</p> <p>In the current study, we utilized a benchmarking strategy (Weersing [<reflink idref="bib43" id="ref33">43</reflink>] ) based on findings from the original RUBI-PT trial (Bearss et al. [<reflink idref="bib5" id="ref34">5</reflink>] ) to evaluate the feasibility of the RUBI-PT program when delivered via telehealth to families in rural communities. Benchmarking is one approach to evaluate an intervention, as it permits the comparison of a service in a new setting against reliably determined effects based on clinical trials or meta-analyses of clinical trials (Weersing [<reflink idref="bib43" id="ref35">43</reflink>] ). In this trial, we define feasibility as evidence that the treatment is acceptable to families, which is measured by parental attendance to PT sessions, adherence to the treatment regimen (completion of in session and homework assignments), and parent ratings of satisfaction post-treatment. Feasibility also includes indicators that the structured manual can be delivered in a consistent manner by therapists across families. Finally, feasibility relates to the ability to reliably collect measures of outcome across the course of the trial, through week 24. Preliminary efficacy is also examined as a means to garner initial signals of improvement in target behaviors. Using benchmarks from the RUBI-PT trial, we will examine the rate of reduction in parent-reported ratings of disruptive behavior on the Aberrant Behavior Checklist-Irritability subscale and the positive response rate of overall improvement on the Clinical Global Impressions-Improvement scale, based on independent evaluator ratings. Establishing the feasibility of RUBI-PT delivered via telehealth as well as signals of preliminary efficacy are necessary prerequisites for justifying a large-scale trial.</p> <hd id="AN0128597951-3">Methods</hd> <hd id="AN0128597951-4">Design</hd> <p>The Institutional Review Board at Emory approved this study and parents of all participants provided written informed consent at the in-person screen visit, prior to collection of study data. This was a 6-month open trial of the RUBI-PT program delivered via telehealth that included 11 core sessions, up to 2 supplemental sessions, and 3 telephone booster sessions. The intervention was delivered by one of four therapists who were trained to reliability. Outcome measures, including parent-reported and independent clinician ratings, were administered at Baseline, weeks 8, 16, and 24.</p> <hd id="AN0128597951-5">PT Treatment Delivery</hd> <p>All sessions of the RUBI-PT program were delivered clinic-to-clinic via telehealth: the treatment center (location of the therapists) connected to one of four regional telemedicine sites where the caregiver(s) were required to present for all sessions. The target child did not have to attend the session as the program is set up primarily as didactics between the therapist and parent. The choice of clinic-to-clinic services versus clinic-to-home was driven by several factors: (<reflink idref="bib1" id="ref36">1</reflink>) the center in which the study was conducted already had in place a sophisticated telehealth system and network, with connections to 30+ sites around the state; (<reflink idref="bib2" id="ref37">2</reflink>) the center in which the study was conducted required HIPAA-compliant connections in the delivery of telehealth-based services; and (<reflink idref="bib3" id="ref38">3</reflink>) at the time of the study, clinical billing for clinic-to-clinic services was routine whereas clinic-to-home services were neither routine nor approved through current insurance funding. Thus, the most feasible pathway for services at the target site involved clinic-to-clinic services.</p> <p>Regional sites included two schools, one regional medical center, and one community medical practice. Remote site treatment rooms included physical exam rooms, conference rooms, or staff offices. All telemedicine sites (treatment center, regional sites) had high-speed internet and videoconferencing capabilities that occurred over a secure, HIPAA-compliant virtual private network (VPN), with transmissions that were encrypted for security. Every regional site had support staff filling administrative roles, including checking families into their appointments, preparing telehealth equipment, and scanning/faxing completed outcome measures. Support staff were not required to stay in the room during the therapy sessions. No interventionists were present at the regional sites and clinical roles were not expected of support staff.</p> <hd id="AN0128597951-6">Participants</hd> <p>Potential participants were enrolled of the study in one of two ways: (<reflink idref="bib1" id="ref39">1</reflink>) referral from a clinician at the study treatment center after completion of an on-site diagnostic evaluation (N = 5); (<reflink idref="bib2" id="ref40">2</reflink>) referral from local school personnel (N = 9). Interested families were directed by the referral source to contact the study coordinator as a means to initiate the phone screen process. To be eligible, children had to have a community diagnosis of autism spectrum disorder, be between 3 and 7 years, 11 months at screening, have an Aberrant Behavior Checklist-Irritability subscale score ≥ 10, and a receptive language age-equivalent of ≥ 12 months. This receptive language cutoff was intended to ensure that children could comprehend simple one-step demands. Participants were also required to be in a stable behavioral or educational program and either on no medication or on a stable dose for at least 6 weeks prior to baseline with no anticipated changes for the duration of the trial. Children of parents who were participating in another parent training program or were unable to travel to the local telehealth site were excluded. PT was provided at no charge. Families received payments of $25 for each treatment visit and $50 for each assessment visit.</p> <hd id="AN0128597951-7">Measures</hd> <hd id="AN0128597951-8">Subject Characterization</hd> <hd id="AN0128597951-9">Demographics Form</hd> <p>This form was developed for the trial to collect information on the child’s sex, age, ethnicity, and school placement, as well as parent age, education, family living arrangement, and income.</p> <hd id="AN0128597951-10">Autism Diagnostic Observation Schedule-Second Edition (ADOS-2; Lord et al. 2012)</hd> <p>The ADOS-2 is a well-established diagnostic instrument that places the child in naturalistic situations, designed to evoke communication and interaction with the examiner. It is organized into four separate modules, based on the age and expressive language level of the child, ranging from pre-verbal toddlers to verbally fluent adults. Behaviors are coded in the areas of social communication, social relatedness, play and imagination, and restricted interests and repetitive behaviors. A child meets criteria for a classification of autism if the scores in the social and communication domains and the total on the algorithm meet or exceed pre-specified cutoff scores. The ADOS has been shown to have sensitivity in the upper 90% range and specificity in the upper 80% to lower 90% range in relation to effectively discriminating between individuals with and without ASD (Lord et al. [<reflink idref="bib24" id="ref41">24</reflink>] ). Internal consistency for all domains and modules range from 0.47 to 0.94. The ADOS was administered by research-reliable clinicians and was used to support the clinical diagnosis of autism spectrum disorder in this sample.</p> <hd id="AN0128597951-11">Cognitive Testing</hd> <p>Thirteen of 14 children completed the Stanford-Binet Intelligence Scales—Fifth Edition (SB-5; Roid [<reflink idref="bib32" id="ref42">32</reflink>] ). The Stanford-Binet assesses intelligence and cognitive strengths and weaknesses in individuals aged 2-85 years. The SB-5 is a well-established IQ test that has been used in previous RUBI studies (Aman et al. [<reflink idref="bib2" id="ref43">2</reflink>] ; Bearss et al. [<reflink idref="bib5" id="ref44">5</reflink>] ). One child completed the Mullen Scales of Early Learning (Mullen [<reflink idref="bib28" id="ref45">28</reflink>] ). The Mullen is designed to measure developmental functioning for infants and children through 68 months of age. The Mullen provides standardized scores in five domains: visual reception (nonverbal problem-solving skills), receptive language (ability to understand language), expressive language (ability to use language and communicate), fine motor skills, and gross motor skills. The early learning composite of the Mullen was used as a proxy for IQ.</p> <hd id="AN0128597951-12">Social Communication Questionnaire Lifetime (SCQ; Rutter et al. 2003)</hd> <p>The SCQ is a 40-item parent-reported questionnaire designed to support the diagnosis of autism spectrum disorder in individuals from 4 to 40 years of age. Each item is checked as ‘yes’ or ‘no’, and assigned a point rating of ‘1’ (presence of abnormal behavior) or ‘0’ (absence of abnormal behavior). The first item is not included in the scoring, as it indicates if the child has sufficient verbal skills for language items to be scored. If the child is not scored as verbal, the six language items are skipped. The points are summed and result in a total possible score of 0-33 for nonverbal children and 0-39 for verbal children. Totals are compared to a cut off of 15 for ASD and 22 for autism (Corsello et al. [<reflink idref="bib10" id="ref46">10</reflink>] ). Internal consistency of the SCQ ranges from 0.84 to 0.93 across age groups (Corsello et al. [<reflink idref="bib11" id="ref47">11</reflink>] ). Using the cut-off score of 15, discriminant validity of the SCQ is adequate for differentiating ASD from non-ASD conditions (sensitivity = 0.71; specificity = 0.71) (Corsello et al. [<reflink idref="bib10" id="ref48">10</reflink>] ).</p> <hd id="AN0128597951-13">Inventory of Educational and Intervention Services (IEIS)</hd> <p>This parent-completed survey was developed by the RUBI Autism Network to gather information from the caregiver about special education services the child is currently receiving. Specifically, the IEIS documents classroom placement, time in mainstream versus special education services, as well as other relevant school-based and private services such as speech therapy, physical therapy, occupational therapy, and the use of a 1:1 aide in the classroom.</p> <hd id="AN0128597951-14">Feasibility Outcome Measures</hd> <hd id="AN0128597951-15">Treatment Fidelity Checklist (TFC)</hd> <p>This measure has been used in prior randomized trials of RUBI-PT to track implementation of session goals and objectives for each PT session (Aman et al. [<reflink idref="bib2" id="ref49">2</reflink>] ; Bearss et al. [<reflink idref="bib5" id="ref50">5</reflink>] ). After completion of each session, therapists rated themselves as: 0 = Goal was not achieved; 1 = Goal was partially achieved; 2 = Goal was fully achieved for each treatment goal for that session. The Core sessions have a range of 6-13 goals per session. The score for each session is expressed as the sum of scores across all items divided by the total possible score × 100.</p> <hd id="AN0128597951-16">Parent Treatment Adherence Scale (PTAS)</hd> <p>The PTAS, which also has been used in prior randomized trials of RUBI-PT (Aman et al. [<reflink idref="bib2" id="ref51">2</reflink>] ; Bearss et al. [<reflink idref="bib5" id="ref52">5</reflink>] ), was completed by the therapist at the end of each PT session to rate parent engagement and understanding of in-session materials and assignments (e.g., answering questions about video vignettes), on a 0-2 scale (Bearss et al. [<reflink idref="bib5" id="ref53">5</reflink>] ). Higher scores indicate greater parent success with in-session assignments. The Core sessions have a range of 3-6 parent adherence objectives per session. The sum of scores is divided by the total possible score × 100.</p> <p>For clinical purposes, therapists completed the TFC and PTAS after each session. To assess therapist fidelity and parent adherence to treatment, all sessions were recorded on video. An independent observer completed these same checklists in a sample of 10% randomly selected sessions.</p> <hd id="AN0128597951-17">Parent Satisfaction Questionnaire (RUPP Autism Network 2007)</hd> <p>This 20-item questionnaire was developed by the RUPP Autism Network. At the end of the PT program, each parent rated the quality of the PT program on the number and length of sessions, the usefulness of teaching tools (e.g., worksheets and homework), the value of program elements, and their confidence in handling future behavioral problems. Items were scored on a 3- or 4-point Likert scale, with higher scores reflecting greater levels of satisfaction.</p> <hd id="AN0128597951-18">Telehealth Caregiver Satisfaction Survey</hd> <p>This 14-item questionnaire was developed for this study to obtain parental feedback at week 24 on the telehealth delivery of the PT program. Questions included ease of making appointments, friendliness of staff and therapists, usefulness of the telehealth equipment and the authenticity of the interaction with the therapist. Responses were rated on a 5-point Likert scale from strongly disagree to strongly agree.</p> <hd id="AN0128597951-19">Telehealth Provider Satisfaction Survey</hd> <p>This 12-item questionnaire, designed for use in this study, was administered to therapists upon completion of each PT case. Therapists rated the ease of using telehealth equipment, perceived barriers and overall quality of delivering PT via telehealth on a 5-point Likert scale from strongly disagree to strongly agree.</p> <hd id="AN0128597951-20">Efficacy Outcome Measures</hd> <hd id="AN0128597951-21">Aberrant Behavior Checklist (ABC; Aman and Singh 2017)</hd> <p>The ABC is a 58-item, parent-report measure that includes five subscales: Irritability (tantrums, aggression and self-injurious behaviors, 15 items); Social Withdrawal (16 items); Stereotypies (7 items); Hyperactivity (16 items); and Inappropriate Speech (4 items). Each item is rated on a Likert-scale of 0-3 with higher scores indicating greater severity. Internal consistency for the five ABC subscales ranges from 0.72 to 0.89. The ABC also has normative data in children with ASD (Kaat et al. [<reflink idref="bib20" id="ref54">20</reflink>] ). In this study, we focused on the Irritability subscale, which has been shown to be sensitive to change with treatment in randomized controlled trials (Research Units on Pediatric Psychopharmacology [<reflink idref="bib30" id="ref55">30</reflink>] ; Bearss et al. [<reflink idref="bib5" id="ref56">5</reflink>] ).</p> <hd id="AN0128597951-22">Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD; Chowdhury et al. 2016)</hd> <p>The HSQ-ASD is a 24-item parent rating of child noncompliance in everyday situations. The measure contains two subscales, with 12 items each (Demand-Specific; Socially Inflexible). Parents are asked whether a given situation posed a problem for the child (yes/no) in the past 4 weeks. “Yes” items are then scored on a 1-9 Likert scale, with higher scores indicating greater noncompliance. The sum of the severity scores on the “yes” items is divided by 24 to obtain a per item mean. Internal consistency is high for the two HSQ-ASD subscales (0.84-0.89) with high concordance between the HSQ-ASD and the Aberrant Behavior Checklist (Chowdhury et al. [<reflink idref="bib9" id="ref57">9</reflink>] ). This version of the HSQ-ASD was used in a prior randomized trial of the RUBI-PT program (Bearss et al. [<reflink idref="bib5" id="ref58">5</reflink>] ).</p> <hd id="AN0128597951-23">Parent Target Problems (PTP; Arnold et al. 2003)</hd> <p>At baseline, the independent evaluator (IE) asked the primary caregiver to describe the child’s two most pressing problems. Using a semi-structured interview, the IE asks about the frequency (for episodic behaviors) or constancy (for problems such as hyperactivity that reflect more enduring patterns), intensity and impact of the behavior on the family. Based on this discussion, the PTPs were documented in a brief narrative. The baseline narrative was reviewed and revised at weeks 8, 16 and 24 to capture a description of the child’s current behavior.</p> <hd id="AN0128597951-24">Clinical Global Impression: Improvement Scale (CGI-I; Guy 1976)</hd> <p>This 7-point scale was completed by an independent evaluator (IE) at weeks 8, 16 and 24 to rate overall change from baseline. Scores range from 1 (very much improved) through 4 (unchanged) to 7 (very much worse). The IE, who was uninvolved in the delivery of PT, used all available information (e.g., the ABC, HSQ-ASD, PTP) to score the CGI-I. Positive response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved) at week 24.</p> <hd id="AN0128597951-25">The Vineland Adaptive Behavior Scales, Second Edition, Parent Interview Format (VABS-II; ...</hd> <p>This version of the VABS-II is completed by the primary caregiver in order to measure the child’s adaptive behavior across three domains: socialization, communication, and daily living skills. The VABS-II asks parents to rate what the child “does” (as opposed to what the child is capable of) in the course of daily living using the following scale: 0 (can not perform), 1 (performs sometimes), or 2 (performs independently). The Vineland II domains have been standardized (mean of 100 ± 15). Internal consistency across domains ranges from 0.83 to 0.90, with test-retest reliability ranging from 0.78 to 0.92 (Sparrow et al. [<reflink idref="bib35" id="ref59">35</reflink>] ). Results from a previous randomized trial of RUBI-PT showed that improvements in disruptive behavior were accompanied by improvement in the standard score in the Vineland daily living domain (Scahill et al. [<reflink idref="bib34" id="ref60">34</reflink>] ).</p> <hd id="AN0128597951-26">PT Intervention</hd> <hd id="AN0128597951-27">PT Manual</hd> <p>Therapists delivered the RUBI Autism Network PT program (Bearss et al. [<reflink idref="bib5" id="ref61">5</reflink>] ). The program included 11 “Core” and up to 2 “Supplemental” sessions over the course of 16 weeks. This pace provided flexibility in scheduling to ensure the full dose of PT for each child and family. It also offered parents time to practice the skills presented in each session. Three telephone booster sessions occurred at weeks 18, 20, and 22 with a focus on generalization and maintenance of skills.</p> <p>The PT manual is designed to address a wide range of behavior and skill deficits in children with ASD and disruptive behavior (see Table 1). The foundation of the PT program is the Antecedent-Behavior-Consequence model. This model identifies the situations or events that precede disruptive behavior (antecedent), the disruptive behavior itself and parental or environmental response (consequence) that may reinforce the behavior in order to determine the purpose or “function” of the child’s behavior. Core sessions focus on teaching this model to parents, presenting techniques for antecedent management, and strategies to implement appropriate consequences such as positive reinforcement, planned ignoring and compliance training. These sessions are followed by teaching techniques such as how to conduct a task analysis and the use of chaining as means to improve the child’s adaptive behaviors (e.g., brushing teeth, hand washing, dressing, tying shoes, working buttons and zippers). This sequence reflects the model that decreasing maladaptive behaviors sets the stage for acquisition and regular performance of everyday living skills. Supplemental sessions, such as toileting, feeding, sleep, and time out were offered according to the needs of specific children.</p> <p></p> <p>The PT manual includes detailed therapist scripts and instructions to promote treatment fidelity. Each 60- to 90-min session uses direct instruction and practice activities to support parent skill acquisition. In addition, each session presents brief video vignettes to illustrate effective and ineffective responses to the child’s behavior or to test parent knowledge of materials covered in the session. Parents also were given homework assignments to complete between sessions. In this telehealth pilot study, we did not conduct home visits (weeks 4 and 22) and we did not include in-session role-play activities. Otherwise, PT via telehealth was not different from the standard “in-person” RUBI-PT protocol (Bearss et al. [<reflink idref="bib5" id="ref62">5</reflink>] ).</p> <hd id="AN0128597951-28">Site Engagement</hd> <p>Involvement of each of the four sites initially involved meetings, both via phone and in-person, of site staff and study investigators. These meetings included an overview of the study, an orientation of the particular site (including telehealth equipment setup) and confirmation of methods to bring families into treatment as well as ensuring delivery of study materials (e.g., questionnaires filled out by participants) from site to study staff.</p> <hd id="AN0128597951-29">PT Delivery</hd> <p>RUBI PT was delivered to each family by one of four therapists [psychology predoctoral intern (N = 1 case); postdoctoral psychology fellow (N = 10 cases); two licensed psychologists (N = 3 cases)]. To ensure that therapists delivered the RUBI-PT program in a competent manner in line with pre-established standards of adherence to the treatment manuals, we implemented a systematic method to train and supervise therapists. Training began with the therapist reviewing the treatment manuals and watching a video of a completed Parent Training case. Once familiar with the program materials, therapists were assigned a case for training on the RUBI-PT program. During the conduct of the training case, therapists received weekly supervision by a certified RUBI-PT therapist. In addition, all sessions were viewed (either live or from recorded videotapes) in order to ensure that the trainee delivered each RUBI-PT session in accordance with the manual with a minimum benchmark of 80% reliability for each session. Therapists were able to treat study families once they had reached 80% reliability on all 11 core sessions.</p> <hd id="AN0128597951-30">Analytic Methods</hd> <hd id="AN0128597951-31">Feasibility</hd> <p>We examined attrition, parent session attendance, adherence to session objectives, and satisfaction with telehealth delivery of PT. We also calculated therapist fidelity to the manual, satisfaction with telehealth delivery, and the rate of successful outcome data collection. Using results from our prior study (Bearss et al. [<reflink idref="bib5" id="ref63">5</reflink>] ) as comparison points, we set the following benchmarks: attrition ≤ 11%, attendance to Core sessions ≥ 92%, parental adherence ≥ 95, ≥ 97% for therapist fidelity. As no prior benchmark as been set for collection of study outcome measures, we established a bar of collecting &gt; 90% of expected measures.</p> <hd id="AN0128597951-32">Preliminary Efficacy</hd> <p>Statistical significance was evaluated at the 0.05 level, and data analyses were performed using SAS v9.4 (Cary, NC). Mixed effects regression, utilizing all available data, was employed to evaluate least squares (LS) mean changes in study end points from Baseline to week 24 for the ABC, HSQ-ASD, and Vineland measures. For each end point, the LS mean difference in measurement outcomes from Baseline to week 24 was estimated together with two-sided 95% confidence intervals (CI). The regression models for each measure included fixed effects for study visit (4 or 2 levels, based on measure). Random effects were the subject-specific intercepts. Model residual errors were confirmed for normality in each case via histograms, boxplots, and quantile-quantile probability plots. Concurrent with the mixed model framework, missing data were assumed to be at random after visual evaluation of the participation logs for patterns in attrition, as well as quantitative analyses considering univariate differences in baseline characteristics between those that attended all their study visits versus those that did not. Effect sizes (ES; standardized mean differences) were calculated to allow comparison of effects across the different assessments and acquired by dividing the absolute LS mean difference by the pooled standard deviation at baseline for each outcome. Effect sizes were considered as small (0.2), medium (0.5), or large (0.8). The proportion of participants showing a positive response on the CGI-I at week 24 was calculated as a percentage.</p> <hd id="AN0128597951-33">Results</hd> <p>Caregivers of 18 children completed the initial telephone screen and 14 (9 boys, 5 girls) subsequently attended the in-person screen visit required for study participation. All 14 were deemed eligible (see Table 2 for demographic data for the sample). Regional sites were an average of 187.5 (SD = 59.4) miles from the study treatment center (range 106-245 miles). Families lived an average of 9.1 miles (SD = 7.9) from their regional telehealth site.</p> <p></p> <p>Baseline demographic and clinical characteristics</p> <p> <ephtml> &lt;table frame="hsides" rules="groups"&gt;&lt;tr&gt;&lt;th align="left"&gt;Characteristic&lt;/th&gt;&lt;th align="left"&gt;N&amp;#8201;=&amp;#8201;14&lt;/th&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;Child demographics&lt;/td&gt;&lt;td align="left" /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Child age, mean&amp;#8201;&amp;#177;&amp;#8201;SD&lt;/td&gt;&lt;td align="left"&gt;5.8&amp;#8201;&amp;#177;&amp;#8201;1.7&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;IQ score, mean&amp;#8201;&amp;#177;&amp;#8201;SD&amp;#42;&lt;/td&gt;&lt;td align="left"&gt;69.4&amp;#8201;&amp;#177;&amp;#8201;17.6&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Gender&amp;#8212;males, N (%)&lt;/td&gt;&lt;td align="left"&gt;9 (64.3%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Race, N (%)&lt;/td&gt;&lt;td align="left" /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;White, Non-Hispanic&lt;/td&gt;&lt;td align="left"&gt;10 (71.4%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;African American, Non-Hispanic&lt;/td&gt;&lt;td align="left"&gt;2 (14.3%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;White, Hispanic&lt;/td&gt;&lt;td align="left"&gt;1 (7.1%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;African American, Hispanic&lt;/td&gt;&lt;td align="left"&gt;1 (7.1%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Diagnosis, N (%)&lt;/td&gt;&lt;td align="left" /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;ASD&amp;#42;&amp;#42;&lt;/td&gt;&lt;td align="left"&gt;12 (85.7%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Psychotropic medication&lt;/td&gt;&lt;td align="left"&gt;7 (50%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;School program, N (%)&lt;/td&gt;&lt;td align="left" /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Regular class&lt;/td&gt;&lt;td align="left"&gt;6 (42.9%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Special education&lt;/td&gt;&lt;td align="left"&gt;7 (50%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Home school&lt;/td&gt;&lt;td align="left"&gt;1 (7.1%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;Caregiver demographics&lt;/td&gt;&lt;td align="left" /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Mother age, mean&amp;#8201;&amp;#177;&amp;#8201;SD&lt;/td&gt;&lt;td align="left"&gt;38.3&amp;#8201;&amp;#177;&amp;#8201;8.3&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Father age, mean&amp;#8201;&amp;#177;&amp;#8201;SD (N&amp;#8201;=&amp;#8201;13)&lt;/td&gt;&lt;td align="left"&gt;39.8&amp;#8201;&amp;#177;&amp;#8201;10.2&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Family makeup, N (%)&lt;/td&gt;&lt;td align="left" /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Intact two-parent family&lt;/td&gt;&lt;td align="left"&gt;5 (35.7%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Parent with partner&lt;/td&gt;&lt;td align="left"&gt;4 (28.6%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Grandparent/adoptive parents&lt;/td&gt;&lt;td align="left"&gt;3 (21.4%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Single parent&lt;/td&gt;&lt;td align="left"&gt;2 (14.3%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left" colspan="2"&gt;&amp;#160;Household income, N (%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;&amp;#60;&amp;#8201;$20,000&lt;/td&gt;&lt;td align="left"&gt;4 (28.6%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;$20,000-$40,000&lt;/td&gt;&lt;td align="left"&gt;5 (35.7%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;$40,001-$60,000&lt;/td&gt;&lt;td align="left"&gt;2 (14.3%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;$60,001-$90,000&lt;/td&gt;&lt;td align="left"&gt;1 (7.1%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;&amp;#62;&amp;#8201;$90,000&lt;/td&gt;&lt;td align="left"&gt;2 (14.3%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Maternal education, N (%)&lt;/td&gt;&lt;td align="left" /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;&amp;#60;&amp;#8201;8th grade&lt;/td&gt;&lt;td align="left"&gt;1 (7.1%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;HS graduate/GED&lt;/td&gt;&lt;td align="left"&gt;1 (7.1%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Some college&lt;/td&gt;&lt;td align="left"&gt;7 (50.0%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;College graduate&lt;/td&gt;&lt;td align="left"&gt;4 (28.6%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Advanced graduate&lt;/td&gt;&lt;td align="left"&gt;1 (7.1%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Miles from home to regional telehealth Site&lt;/td&gt;&lt;td align="left"&gt;9.1&amp;#8201;&amp;#177;&amp;#8201;7.9&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;Child clinical characteristics&lt;/td&gt;&lt;td align="left" /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;CGI&amp;#8212;severity, N (%)&lt;/td&gt;&lt;td align="left" /&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Moderately Ill&lt;/td&gt;&lt;td align="left"&gt;9 (64.3%)&lt;/td&gt;&lt;/tr&gt;&lt;tr&gt;&lt;td align="left"&gt;&amp;#160;&amp;#160;Markedly Ill&lt;/td&gt;&lt;td align="left"&gt;5 (35.7%)&lt;/td&gt;&lt;/tr&gt;&lt;/table&gt; </ephtml> </p> <p>*3 participants (21.4%) had a receptive language below 18 months</p> <p>**2 participants did not meet ASD criteria on the ADOS but held a community diagnosis of ASD</p> <p>At pre-treatment, 50% of children were on psychotropic medications. All participants had a community diagnosis of ASD. While a community diagnosis of ASD was acceptable for enrollment in the study, the diagnosis of ASD was confirmed in 12 of 14 children during the baseline assessment. Based on gold standard tools (ADOS) and clinician judgment, two children were deemed to not meet DSM-IV-TR criteria for ASD. One family dropped out between baseline and the first session. All remaining families (N = 13) completed the trial. All 14 families were included in the analyses.</p> <hd id="AN0128597951-34">Feasibility Outcomes</hd> <p>Table 3 compares the pre-specified benchmarks, based on results from the original RUBI PT trial (Bearss et al. [<reflink idref="bib5" id="ref64">5</reflink>] ) to feasibility outcomes from this pilot trial. One of 14 participants (7.1%) exited the trial prior to week 24. Of the 154 expected core sessions (11 sessions × 14 participants), actual attendance was 141 (91.6%). Most caregivers who completed the Parent Satisfaction Questionnaire (11 of 13; 84.6%) reported that the number of sessions was appropriate. All 13 caregivers who completed the PT program reported greater confidence to manage current and future disruptive behaviors, and all 13 caregivers indicated that they would recommend the program to other parents of children ASD and with similar problems. Twelve of 14 families completed the Telehealth Caregiver Satisfaction Survey. All 12 endorsed “agree” or “strongly agree” in feeling comfortable with the delivery of PT via telehealth and all would recommend PT by telehealth to other parents. However, 4 of 12 caregivers (33%) endorsed “agree/strongly agree” or “unsure” that telehealth unnecessarily complicated the delivery of PT.</p> <p></p> <p>The telehealth PT program was delivered by four therapists. On the Telehealth Provider Satisfaction Survey, all “disagreed” that telehealth interfered with the delivery of PT and all “disagreed/strongly disagreed” that the telehealth equipment was too complicated to use. Two of four therapists reported that delivery of PT via telehealth was just as good as delivering in clinic; two endorsed feeling “unsure” on this point.</p> <p>Video recordings of the 10% randomly selected sessions (14 of 135 available Core sessions) were independently reviewed by a RUBI-PT trained therapist. Therapist fidelity to the manual was 98.2%, and parent adherence (engagement and understanding of in-session material) was high (94.6% of in-session goals completed). Regarding collection of outcome measures, 85.7% (12/14) of parent-report measures (ABC, HSQ-ASD) at week 8, and 92.9% (13/14) at weeks 16 and 24 were returned.</p> <hd id="AN0128597951-35">Preliminary Efficacy Outcomes</hd> <p>From Baseline to week 24, there were statistically significant improvements on the parent-rated ABC-I and HSQ-ASD, with effect sizes at 1.25 and 0.86, respectively. ABC-I subscale scores declined from 25.00 (SE: 2.36) at Baseline to 13.58 (SE: 2.40) at week 24 (p &lt; 0.001; Difference: − 11.42, CI − 14.73, − 8.11; 45.6% reduction). Per-item mean scores on the HSQ-ASD declined from 3.65 (SE: 0.41) at Baseline to 2.21 (SE: 0.42) at week 24 (p &lt; 0.001; Difference: − 1.44, CI − 2.10, − 0.77; 39.5% reduction) (see Table 4). The Social Withdrawal, Stereotypies, Hyperactivity, and Inappropriate Speech subscales of the ABC also showed significant improvement from Baseline to week 24 (p &lt; 0.05). All Vineland Domain Standard Scores failed to improve significantly from Baseline to week 24 (see Fig. 1). On the CGI-I, 11 of 14 participants (78.6%) were rated as much improved or very much improved by the independent evaluator (note: the subject who dropped out was rated as a non-responder).</p> <p></p> <p>Mixed model LS mean Vineland domain scores and standard errors from Baseline to Week 24</p> <hd id="AN0128597951-36">Discussion</hd> <p>Results from this pilot trial support the feasibility and preliminary efficacy of the 24-week RUBI parent training program for children with ASD and disruptive behavior when delivered via telehealth. The intervention was acceptable to caregivers as evidenced by a 93% rate of completion, 92% attendance of core sessions and 95% of attainment of session objectives. Therapists delivered the manual in a consistent fashion as evidenced by 98% fidelity on a random sample of sessions viewed by independent reviewers. Outcome data collection across the 24-week trial exceeded 90%. Although the study was not designed to test the efficacy of PT via telehealth, the results are consistent with the findings from a recent large-scale randomized clinical trial (Bearss et al. [<reflink idref="bib5" id="ref65">5</reflink>] ). In short, findings from this pilot trial suggest that even with required modifications to the original protocol (e.g., elimination of the home visits and role-play), RUBI PT can be delivered reliably by therapists to caregivers off-site with high rates of engagement and satisfaction.</p> <p>The children and families in the telehealth study, however, had important differences from the multisite trial (Bearss et al. [<reflink idref="bib5" id="ref66">5</reflink>] ). For example, 50% of children were intellectually disabled compared to 25% in the previous trial. Only 36% (n = 5) of children lived in intact, 2-parent families compared to 88% in our multisite trial. In the multisite trial, 62% of caregivers had college or advanced degrees compared to 36% among participating families in this telehealth trial. Demonstrating the feasibility of PT by telehealth in this diverse sample of socioeconomically challenged families is a small but important step toward implementation of an evidenced-based treatment in underserved rural areas.</p> <p>The successful conduct of the study required site engagement and buy-in. For example, staff at each site was responsible for registration, room scheduling, maintenance of the telehealth equipment, and transmission of study data to the research site. The process of engaging sites included teleconferences with team members as well as site visits during the enrollment phase.</p> <p>This project involved treatment delivery from a specialized autism center to four rural community sites (one hospital, one primary care center, two schools). The choice to evaluate clinic-to-clinic service delivery was driven by the presence of a well-developed statewide telehealth system and network, the hospital requirement that services be delivered on a HIPAA-compliant network, and the potential to deliver clinic-to-clinic services as a reimbursable service (billing clinic-to-home was not an option at the time of this study). Clinic-to-clinic (e.g., Wacker et al. [<reflink idref="bib40" id="ref67">40</reflink>] , [<reflink idref="bib41" id="ref68">41</reflink>] ) as well as clinic-to-home (Suess et al. [<reflink idref="bib36" id="ref69">36</reflink>] ; Vismara et al. [<reflink idref="bib39" id="ref70">39</reflink>] , [<reflink idref="bib38" id="ref71">38</reflink>] ) are just two of several potential service delivery models utilizing technology that are currently being explored. Clinic-to-clinic has the following advantages: (<reflink idref="bib1" id="ref72">1</reflink>) services can be conducted over HIPAA-secure networks; (<reflink idref="bib2" id="ref73">2</reflink>) increased reliability of the technology used; (<reflink idref="bib3" id="ref74">3</reflink>) increased potential to bill for services; and (<reflink idref="bib4" id="ref75">4</reflink>) the availability of support staff to address technological issues. Challenges include the need for families travel to a center in order to receive services. In contrast, clinic-to-home services decrease logistical burdens such as transportation and allow for treatment in more naturalistic setting, but it conversely requires access to internet-supported services. In the Suess et al. ([<reflink idref="bib36" id="ref76">36</reflink>] ) trial of functional communication training, families were given internet access as well as a Windows-based laptop, webcam, and Ethernet cable if they did not already own the necessary equipment (Lee et al. [<reflink idref="bib22" id="ref77">22</reflink>] ). Finally, billing for clinic-to-home services is not yet universally accepted.</p> <p>Although the findings of this study were positive, the conduct of the trial encountered several challenges. For example, at the regional medical center, parents were required to check in at the hospital registration desk before being seen in the telehealth clinic. Missed communication between the registration desk and the clinic resulted in unintended wait-times for some appointments and occasionally resulted in missed appointments. At the school sites, booking the one available telehealth conference room for PT appointments was occasionally preempted by school meetings. Conducting treatment at schools also required the team to provide treatment around school holidays, and both school sites were closed for the summer, requiring treatment to occur from August to May. Finally, at all four telehealth sites there were screen freezes, timing lags and video connections occasionally dropped. Despite these challenges, we still achieved a high rate of session attendance due in no small part to the flexibility of the telehealth sites, parents and caregivers.</p> <p>Although promising, this pilot study has several limitations. First, this was a small sample and there was no control group. In the absence of a control group, it is not possible to separate the effects of treatment from the effect of time or attention on disruptive behavior in this sample of children with ASD. In addition, parent- and clinician-ratings of change in child behavior was not blinded. Confidence in the outcome data is bolstered by the availability of data from two groups of clinicians who were independent of one another and uninvolved in the treatment of the child: the independent evaluator who completed ratings of child progress over time, and the independent rater of therapist fidelity and parent adherence. All clinicians, nonetheless, were aware of the child’s treatment status. Thus, these results may provide proof-of-concept but not certainty in outcomes. Families also were paid for participation in all assessment and treatment visits. This may impact generalizability of findings, as parents are will have to pay for services in clinical settings. Finally, the small sample size limits the generalizability of efficacy findings.</p> <p>This project fits in with our long-term interest in the application of PT into routine care for young children with ASD and disruptive behavior. A large-scale randomized clinical trial controlling for time and attention, as well as blinded approaches to outcome measurement, is needed to test whether PT via telehealth is a viable way to extend the reach of this evidenced based treatment to underserved rural areas. There are many pathways toward this goal. Direct service to parents via telehealth by experts at a major medical center to community settings as done in this study is one model. Alternatively, telehealth could be used to train clinicians in underserved areas. A third possibility is to train clinicians in community clinics that do not have telehealth capacity. All approaches should consider the implications of cost and resource allocation when evaluating new models of implementation.</p> <hd id="AN0128597951-37">Acknowledgements</hd> <p>The authors thank Felissa Goldstein, MD for her for support of this project. This publication was made possible by the following grants: the National Institute of Mental Health NIMH R01 MH081148 (Principal investigator: L. Scahill); the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR000454. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.</p> <hd id="AN0128597951-38">Author Contributions</hd> <p>KB contibuted to concept/design, acquisition of data, analysis/interpretation, drafting of manuscript, critical revision. TLB contibuted to acquisition of data, analysis/interpretation, drafting, revision. SAC contibuted to acquisition of dta, analysis/interpretation, drafting, revision. VP contibuted to analysis/interpretation, drafting, revision. SEG contibuted to analysis/interpretation, drafting, revision. CC contibuted to concept design, acquisition, drafting, revision. LS contibuted to concept/design, acquisition, analysis/interpretation, drafting, revision.</p> <hd id="AN0128597951-39">Compliance with Ethical Standards</hd> <hd id="AN0128597951-40">Conflict of interest</hd> <p>Dr. Scahill serves as a consultant for Neuren, Coronado, Roche, MedAdvante, and Shire. Drs. Bearss, Burrell, Postorino, Crooks, Mr. Gillespie and Ms. Challa have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript.</p> <hd id="AN0128597951-41">Ethical Approval</hd> <p>All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.</p> <hd id="AN0128597951-42">Informed Consent</hd> <p>Informed consent was obtained from parents or legal guardians of all participants included in the study.</p> <hd id="AN0128597951-43">References</hd> <hd id="AN0128597951-44">Citations</hd> <p>1 Aman MG, Singh NN, Aberrant behavior checklist (ABC-2), 2017, 2, East Aurora, NY, Slosson Publishing</p> <ulist> <item>2 Aman MG, McDougle CJ, Scahill L, Handen B, Arnold LE, Johnson C, Medication and parent training in children with pervasive developmental disorders and serious behavior problems: Results from a randomized clinical trial, Journal of the American Academy of Child and Adolescent Psychiatry, 2009, 48, 1143, 1154, 10.1097/CHI.0b013e3181bfd669</item> <item>3 Diagnostic and statistical manual of mental disorders: DSM-5, 2013, 5, Washington, DC, American Psychiatric Association</item> <item>4 Arnold LE, Vitiello B, McDougle C, Scahill L, Shah B, Gonzalez NM, Parent-defined target symptoms respond to risperidone in RUPP autism study: Customer approach to clinical trials, Journal of the American Academy of Child and Adolescent Psychiatry, 2003, 42, 12, 1443, 14450, 10.1097/00004583-200312000-00011</item> <item>5 Bearss K, Johnson C, Smith T, Lecavalier L, Swiezy N, Aman M, Effect of parent training vs parent education on behavioral problems in children with autism spectrum disorder: A randomized clinical trial, JAMA: The Journal of the American Medical Association, 2015, 313, 15, 1524, 1533, 10.1001/jama.2015.3150</item> <item>6 Belfer ML, Saxena S, WHO Child Atlas Project, Lancet, 2006, 367, 551, 552, 10.1016/S0140-6736(06)68199-3</item> <item>7 Boisvert M, Lang R, Andrianopoulos M, Bocardin ML, Telepractice in the assessment and treatment of individuals with autism spectrum disorders: A systematic review, Developmental Neurorehabilitation, 2010, 13, 423, 432, 10.3109/17518423.2010.499889</item> <item>8 Centers for Disease Control and Prevention (CDC), Prevalence of autism spectrum disorder among children aged 8 years—Autism and Developmental Disabilities Monitoring Network, 11 sites, United States, 2010, Morbidity and Mortality Weekly Report. 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Retrieved 22 October 2012, http://who.int/metnal_health/evidence/atlas_id_2007.pdf.</item> <item>45 Zablotsky B, Black LI, Maenner MJ, Schieve LA, Blumberg SJ, Estimated Prevalence of Autism and Other Developmental Disabilities Following Questionnaire Changes in the 2014 National Health Interview Survey, National Health Statistics Reports, 2015, 87, 1, 21</item> </ulist> <p>PHOTO (COLOR)</p> <aug> <p>By Karen Bearss; T. Lindsey Burrell; Saankari A. Challa; Valentina Postorino; Scott E. Gillespie; Courtney Crooks and Lawrence Scahill</p> </aug> <nolink nlid="nl1" bibid="bib3" firstref="ref1"></nolink> <nolink nlid="nl2" bibid="bib8" firstref="ref2"></nolink> <nolink nlid="nl3" bibid="bib14" firstref="ref3"></nolink> <nolink nlid="nl4" bibid="bib45" firstref="ref4"></nolink> <nolink nlid="nl5" bibid="bib6" firstref="ref5"></nolink> <nolink nlid="nl6" bibid="bib44" firstref="ref6"></nolink> <nolink nlid="nl7" bibid="bib40" firstref="ref7"></nolink> <nolink nlid="nl8" bibid="bib41" firstref="ref8"></nolink> <nolink nlid="nl9" bibid="bib13" firstref="ref9"></nolink> <nolink nlid="nl10" bibid="bib12" firstref="ref10"></nolink> <nolink nlid="nl11" bibid="bib7" firstref="ref11"></nolink> <nolink nlid="nl12" bibid="bib23" firstref="ref12"></nolink> <nolink nlid="nl13" bibid="bib37" firstref="ref13"></nolink> <nolink nlid="nl14" bibid="bib18" firstref="ref16"></nolink> <nolink nlid="nl15" bibid="bib19" firstref="ref17"></nolink> <nolink nlid="nl16" bibid="bib29" firstref="ref18"></nolink> <nolink nlid="nl17" bibid="bib42" firstref="ref19"></nolink> <nolink nlid="nl18" bibid="bib39" firstref="ref20"></nolink> <nolink nlid="nl19" bibid="bib38" firstref="ref21"></nolink> <nolink nlid="nl20" bibid="bib16" firstref="ref22"></nolink> <nolink nlid="nl21" bibid="bib27" firstref="ref23"></nolink> <nolink nlid="nl22" bibid="bib26" firstref="ref24"></nolink> <nolink nlid="nl23" bibid="bib34" firstref="ref25"></nolink> <nolink nlid="nl24" bibid="bib17" firstref="ref26"></nolink> <nolink nlid="nl25" bibid="bib21" firstref="ref27"></nolink> <nolink nlid="nl26" bibid="bib5" firstref="ref28"></nolink> <nolink nlid="nl27" bibid="bib43" firstref="ref33"></nolink> <nolink nlid="nl28" bibid="bib1" firstref="ref36"></nolink> <nolink nlid="nl29" bibid="bib2" firstref="ref37"></nolink> <nolink nlid="nl30" bibid="bib24" firstref="ref41"></nolink> <nolink nlid="nl31" bibid="bib32" firstref="ref42"></nolink> <nolink nlid="nl32" bibid="bib28" firstref="ref45"></nolink> <nolink nlid="nl33" bibid="bib10" firstref="ref46"></nolink> <nolink nlid="nl34" bibid="bib11" firstref="ref47"></nolink> <nolink nlid="nl35" bibid="bib20" firstref="ref54"></nolink> <nolink nlid="nl36" bibid="bib30" firstref="ref55"></nolink> <nolink nlid="nl37" bibid="bib9" firstref="ref57"></nolink> <nolink nlid="nl38" bibid="bib35" firstref="ref59"></nolink> <nolink nlid="nl39" bibid="bib36" firstref="ref69"></nolink> <nolink nlid="nl40" bibid="bib4" firstref="ref75"></nolink> <nolink nlid="nl41" bibid="bib22" firstref="ref77"></nolink> |
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| Items | – Name: Title Label: Title Group: Ti Data: Feasibility of Parent Training via Telehealth for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot – Name: Language Label: Language Group: Lang Data: English – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Bearss%2C+Karen%22">Bearss, Karen</searchLink><br /><searchLink fieldCode="AR" term="%22Burrell%2C+T%2E+Lindsey%22">Burrell, T. Lindsey</searchLink><br /><searchLink fieldCode="AR" term="%22Challa%2C+Saankari+A%2E%22">Challa, Saankari A.</searchLink><br /><searchLink fieldCode="AR" term="%22Postorino%2C+Valentina%22">Postorino, Valentina</searchLink><br /><searchLink fieldCode="AR" term="%22Gillespie%2C+Scott+E%2E%22">Gillespie, Scott E.</searchLink><br /><searchLink fieldCode="AR" term="%22Crooks%2C+Courtney%22">Crooks, Courtney</searchLink><br /><searchLink fieldCode="AR" term="%22Scahill%2C+Lawrence%22">Scahill, Lawrence</searchLink> – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="SO" term="%22Journal+of+Autism+and+Developmental+Disorders%22"><i>Journal of Autism and Developmental Disorders</i></searchLink>. Apr 2018 48(4):1020-1030. – Name: Avail Label: Availability Group: Avail Data: Springer. 233 Spring Street, New York, NY 10013. Tel: 800-777-4643; Tel: 212-460-1500; Fax: 212-348-4505; e-mail: service-ny@springer.com; Web site: http://www.springerlink.com – Name: PeerReviewed Label: Peer Reviewed Group: SrcInfo Data: Y – Name: Pages Label: Page Count Group: Src Data: 11 – Name: DatePubCY Label: Publication Date Group: Date Data: 2018 – Name: SourceSuprt Label: Sponsoring Agency Group: SrcSuprt Data: National Institute of Mental Health (DHHS/NIH)<br />National Center for Advancing Translational Sciences (NCATS) (DHHS/NIH) – Name: NumberContract Label: Contract Number Group: NumCntrct Data: MH081148<br />UL1TR000454 – Name: TypeDocument Label: Document Type Group: TypDoc Data: Journal Articles<br />Reports - Research – Name: Audience Label: Education Level Group: Audnce Data: <searchLink fieldCode="EL" term="%22Adult+Education%22">Adult Education</searchLink> – Name: Subject Label: Descriptors Group: Su Data: <searchLink fieldCode="DE" term="%22Parents%22">Parents</searchLink><br /><searchLink fieldCode="DE" term="%22Pervasive+Developmental+Disorders%22">Pervasive Developmental Disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Autism%22">Autism</searchLink><br /><searchLink fieldCode="DE" term="%22Rural+Areas%22">Rural Areas</searchLink><br /><searchLink fieldCode="DE" term="%22Young+Children%22">Young Children</searchLink><br /><searchLink fieldCode="DE" term="%22Parent+Education%22">Parent Education</searchLink><br /><searchLink fieldCode="DE" term="%22Outcome+Measures%22">Outcome Measures</searchLink><br /><searchLink fieldCode="DE" term="%22Feasibility+Studies%22">Feasibility Studies</searchLink><br /><searchLink fieldCode="DE" term="%22Pilot+Projects%22">Pilot Projects</searchLink><br /><searchLink fieldCode="DE" term="%22Student+Behavior%22">Student Behavior</searchLink><br /><searchLink fieldCode="DE" term="%22Behavior+Problems%22">Behavior Problems</searchLink><br /><searchLink fieldCode="DE" term="%22Access+to+Health+Care%22">Access to Health Care</searchLink><br /><searchLink fieldCode="DE" term="%22Telecommunications%22">Telecommunications</searchLink><br /><searchLink fieldCode="DE" term="%22Health+Services%22">Health Services</searchLink><br /><searchLink fieldCode="DE" term="%22Allied+Health+Personnel%22">Allied Health Personnel</searchLink><br /><searchLink fieldCode="DE" term="%22Outcomes+of+Treatment%22">Outcomes of Treatment</searchLink> – Name: DOI Label: DOI Group: ID Data: 10.1007/s10803-017-3363-2 – Name: ISSN Label: ISSN Group: ISSN Data: 0162-3257 – Name: Abstract Label: Abstract Group: Ab Data: Telehealth is a potential solution to limited access to specialized services for children with autism spectrum disorder (ASD) in rural areas. We conducted a feasibility trial of parent training with children ages 3-8 with ASD and disruptive behavior from rural communities. Fourteen children (mean age 5.8 ± 1.7) from four telehealth sites enrolled. Thirteen families (92.9%) completed treatment, with 91.6% of core sessions attended. Therapists attained 98% fidelity to the manual and 93% of expected outcome measures were collected at week 24. Eleven of 14 (78.6%) participants were rated as much/very much improved. Parent training via telehealth was acceptable to parents and treatment could be delivered reliably by therapists. Preliminary efficacy findings suggests further study is justified. – Name: AbstractInfo Label: Abstractor Group: Ab Data: As Provided – Name: Ref Label: Number of References Group: RefInfo Data: 45 – Name: DateEntry Label: Entry Date Group: Date Data: 2018 – Name: AN Label: Accession Number Group: ID Data: EJ1173373 |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=eric&AN=EJ1173373 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s10803-017-3363-2 Languages: – Text: English PhysicalDescription: Pagination: PageCount: 11 StartPage: 1020 Subjects: – SubjectFull: Parents Type: general – SubjectFull: Pervasive Developmental Disorders Type: general – SubjectFull: Autism Type: general – SubjectFull: Rural Areas Type: general – SubjectFull: Young Children Type: general – SubjectFull: Parent Education Type: general – SubjectFull: Outcome Measures Type: general – SubjectFull: Feasibility Studies Type: general – SubjectFull: Pilot Projects Type: general – SubjectFull: Student Behavior Type: general – SubjectFull: Behavior Problems Type: general – SubjectFull: Access to Health Care Type: general – SubjectFull: Telecommunications Type: general – SubjectFull: Health Services Type: general – SubjectFull: Allied Health Personnel Type: general – SubjectFull: Outcomes of Treatment Type: general Titles: – TitleFull: Feasibility of Parent Training via Telehealth for Children with Autism Spectrum Disorder and Disruptive Behavior: A Demonstration Pilot Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Bearss, Karen – PersonEntity: Name: NameFull: Burrell, T. Lindsey – PersonEntity: Name: NameFull: Challa, Saankari A. – PersonEntity: Name: NameFull: Postorino, Valentina – PersonEntity: Name: NameFull: Gillespie, Scott E. – PersonEntity: Name: NameFull: Crooks, Courtney – PersonEntity: Name: NameFull: Scahill, Lawrence IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 04 Type: published Y: 2018 Identifiers: – Type: issn-print Value: 0162-3257 Numbering: – Type: volume Value: 48 – Type: issue Value: 4 Titles: – TitleFull: Journal of Autism and Developmental Disorders Type: main |
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