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Brief Parent-Mediated Intervention for Children with Autism Spectrum Disorder: A Feasibility Study from South India

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Title: Brief Parent-Mediated Intervention for Children with Autism Spectrum Disorder: A Feasibility Study from South India
Language: English
Authors: Manohar, Harshini, Kandasamy, Preeti, Chandrasekaran, Venkatesh, Rajkumar, Ravi Philip
Source: Journal of Autism and Developmental Disorders. Aug 2019 49(8):3146-3158.
Availability: Springer. Available from: Springer Nature. 233 Spring Street, New York, NY 10013. Tel: 800-777-4643; Tel: 212-460-1500; Fax: 212-348-4505; e-mail: customerservice@springernature.com; Web site: https://link.springer.com/
Peer Reviewed: Y
Page Count: 13
Publication Date: 2019
Document Type: Journal Articles
Reports - Research
Descriptors: Foreign Countries, Intervention, Parents as Teachers, Behavior Modification, Home Programs, Feasibility Studies, Young Children, Autism, Pervasive Developmental Disorders, Anxiety, Program Effectiveness
Geographic Terms: India
DOI: 10.1007/s10803-019-04032-x
ISSN: 0162-3257
Abstract: The study assesses the acceptability and feasibility of a brief parent-mediated home-based intervention for children with autism spectrum disorder (ASD), deliverable in resource-limited settings, with an emphasis on addressing parental stress from a socio-cultural perspective. 50 children (2-6 years), with a DSM 5 diagnosis of ASD were randomized to intervention (n = 26) or active control group (n = 24). The intervention based on naturalistic developmental behavioral approach, focusing on joint attention, imitation, social and adaptive skills was structured to be delivered in five outpatient sessions over 12 weeks. All children were followed up at 4, 8 and 12 weeks. Parents of children randomized to the intervention group reported more improvements across parental stress and child outcome measures compared to those in the control group. The intervention was found to be acceptable and feasible, with high fidelity measures and retention rates.
Abstractor: As Provided
Entry Date: 2019
Accession Number: EJ1221792
Database: ERIC
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  Value: <anid>AN0137441304;aut01aug.19;2019Jul13.07:13;v2.2.500</anid> <title id="AN0137441304-1">Brief Parent-Mediated Intervention for Children with Autism Spectrum Disorder: A Feasibility Study from South India </title> <p>The study assesses the acceptability and feasibility of a brief parent-mediated home-based intervention for children with autism spectrum disorder (ASD), deliverable in resource-limited settings, with an emphasis on addressing parental stress from a socio-cultural perspective. 50 children (2–6 years), with a DSM 5 diagnosis of ASD were randomized to intervention (n = 26) or active control group (n = 24). The intervention based on naturalistic developmental behavioral approach, focusing on joint attention, imitation, social and adaptive skills was structured to be delivered in five outpatient sessions over 12 weeks. All children were followed up at 4, 8 and 12 weeks. Parents of children randomized to the intervention group reported more improvements across parental stress and child outcome measures compared to those in the control group. The intervention was found to be acceptable and feasible, with high fidelity measures and retention rates.</p> <p>Keywords: Autism spectrum disorder; ASD; Intervention; Parent-mediated; Parental stress; India; Low-resource</p> <p>Electronic supplementary material The online version of this article (10.1007/s10803-019-04032-x) contains supplementary material, which is available to authorized users.</p> <hd id="AN0137441304-2">Introduction</hd> <p>Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by marked impairment in reciprocal social interaction and communication, and repetitive behavior (APA [<reflink idref="bib2" id="ref1">2</reflink>]). Recently, there has been an increasing worldwide prevalence of ASD, with an estimated prevalence of 0.5–1% (Elsabbagh et al. [<reflink idref="bib13" id="ref2">13</reflink>]). According to the global estimates, a significant proportion of the global population belongs to the low-and-middle-income countries (LAMICs). In the LAMICs, where the health care resources are limited, a 90–10 gap in accessibility to mental health services continues to exist (Reichow et al. [<reflink idref="bib39" id="ref3">39</reflink>]). Disorder-specific interventions are delivered by trained personnel in specialist child development centres. However, the majority of the patient population visiting the readily accessible, resource-limited primary care settings receive non-specific interventions or no treatment at all. (Harshini and Preeti [<reflink idref="bib18" id="ref4">18</reflink>]).</p> <p>Many international studies have proven the efficacy of developmental interventions and have recommended such interventions as an integral part of the treatment of children with ASD (Schreibman et al. [<reflink idref="bib44" id="ref5">44</reflink>]). These studies have tested intensive interventions developed in the high-income countries. These are typically delivered by trained professionals and are labor and time-intensive. There is a paucity of high-quality studies and randomized controlled trials establishing the efficacy and feasibility of ASD interventions in the LAMIC settings. The lack of culturally-appropriate intervention modules and trained personnel for service delivery necessitates employing alternate strategies for intervention testing in resource-limited settings. Adapting the existing intervention modules developed in the high-income countries and task-shifting for non-specialist delivery has been attempted and found to be effective (Divan et al. [<reflink idref="bib9" id="ref6">9</reflink>]; Green et al. [<reflink idref="bib17" id="ref7">17</reflink>]; Rahman et al. [<reflink idref="bib38" id="ref8">38</reflink>]). In a global health context, developing low-cost, culturally-relevant and feasible interventions have been proposed to improve service delivery (Hastings et al. [<reflink idref="bib20" id="ref9">20</reflink>]; Reichow et al. [<reflink idref="bib39" id="ref10">39</reflink>]).</p> <p>Involving parents in the treatment process of children with ASD is seen as an essential strategy (Hastings et al. [<reflink idref="bib20" id="ref11">20</reflink>]; McConachie and Diggle [<reflink idref="bib29" id="ref12">29</reflink>]). Parents and parent-mediated interventions form a vital role in improving affordability and accessibility, more so in resource-limited settings. The inclusion of parents in therapist-delivered early intensive behavioral interventions (EIBI) was found to have positive effects in increasing parental fidelity to treatment, reducing the child's behavior problems and parental distress (Strauss et al. [<reflink idref="bib46" id="ref13">46</reflink>]).</p> <p>The average age of diagnosis of ASD in India is around 3–6 years and a time delay of 2 years from symptom recognition to treatment initiation is observed across different health care settings (Daley [<reflink idref="bib5" id="ref14">5</reflink>]; Kommu et al. [<reflink idref="bib27" id="ref15">27</reflink>]). 'Professional-as-consultant' and 'parent-as-therapist' model can bridge the current lack of specialists. Parent-mediated interventions, if delivered by pediatricians and primary care physicians at the first contact, can prevent delay in the initiation of interventions.</p> <p>Parents of children with ASD experience higher levels of stress in the personal and social spheres when compared to parents of typically developing children (Desai et al. [<reflink idref="bib8" id="ref16">8</reflink>]; Divan et al. [<reflink idref="bib10" id="ref17">10</reflink>]; Estes et al. [<reflink idref="bib14" id="ref18">14</reflink>]). Parental mental health, perceived stress and family adaptation have been found to influence child-related outcomes in early interventions, both in the short and long-term (Osborne et al. [<reflink idref="bib33" id="ref19">33</reflink>]; Ozonoff and Cathcart [<reflink idref="bib34" id="ref20">34</reflink>]). Lesser stress levels in the parents have been shown to improve intervention gains, and in turn, treatment-related positive outcomes have a positive effect on parental stress (Hastings et al. [<reflink idref="bib20" id="ref21">20</reflink>]). Also, the lack of improvement in child-related outcomes was found to increase parental stress (Oosterling et al. [<reflink idref="bib32" id="ref22">32</reflink>]). It is essential to address parental stress and enhance coping for better parental engagement, more so if interventions are parent-delivered (Harshini and Preeti [<reflink idref="bib18" id="ref23">18</reflink>]). Recent Cochrane systemic reviews on parent-mediated interventions for ASD also emphasize the need for systematically evaluating and addressing parental stress (Oono et al. [<reflink idref="bib31" id="ref24">31</reflink>]). Culture plays a vital role in determining the factors that mediate parental stress and coping (Srinath and Jacob [<reflink idref="bib45" id="ref25">45</reflink>]). Also, cultural belief systems strongly influence the family's understanding of the child's disorder. Understanding and addressing parental stress from a cultural perspective can help in prioritizing issues of relevance to the community and plan culturally-relevant and appropriate interventional strategies (Daley et al. [<reflink idref="bib6" id="ref26">6</reflink>]).</p> <hd id="AN0137441304-3">The Current Study</hd> <p>The current study aimed to evaluate the acceptability and feasibility of an ASD-specific behavioral intervention, deliverable in resource limited settings, over a brief time frame. The randomized control trial (RCT) design was chosen to address the paucity of ASD interventional studies in the LAMIC settings. The aims of the RCT are (<reflink idref="bib1" id="ref27">1</reflink>) to assess the acceptability and feasibility of the parent-mediated intervention model, delivered on an out-patient basis over 12 weeks (<reflink idref="bib2" id="ref28">2</reflink>) to assess the impact of the intervention on parental stress and coping</p> <p>The components of the study intervention are adapted from the good intervention practices followed in specialist child psychiatry centers and institutes of national importance in India (Girimaji et al. [<reflink idref="bib16" id="ref29">16</reflink>]), which include the principles of Naturalistic Developmental Behavioral Interventions (NDBI) as one of the reference models (Ingersoll and Schreibman [<reflink idref="bib21" id="ref30">21</reflink>]; Schreibman et al. [<reflink idref="bib44" id="ref31">44</reflink>]). The outpatient delivery and parent-mediated model were chosen to suit the needs of our patient population and to deliver ASD-specific interventions with the limited available resources. Existing challenges in the low-resource settings were reviewed, and the steps taken to address them while conceptualizing, designing and testing the intervention module are described elsewhere (Harshini and Preeti [<reflink idref="bib18" id="ref32">18</reflink>]). The module is designed to (<reflink idref="bib1" id="ref33">1</reflink>) facilitate intervention delivery in the resource-limited settings, (<reflink idref="bib2" id="ref34">2</reflink>) to address parental stress and coping from a cultural perspective (<reflink idref="bib3" id="ref35">3</reflink>) to curtail the existing treatment gap.</p> <hd id="AN0137441304-4">Methodology</hd> <p></p> <hd id="AN0137441304-5">Setting</hd> <p>The study was conducted in the Child Guidance Clinic (CGC) of a non-funded tertiary care hospital in India, from June 2015 to June 2017. CGC runs in liaison between Department of Psychiatry and Pediatrics and caters to about 200–300 children a month.</p> <hd id="AN0137441304-6">Study Design</hd> <p>The study design was a pilot randomized controlled trial with two parallel arms:</p> <p></p> <ulist> <item> Intervention group received brief parent-mediated intervention, in addition to Treatment as usual (TAU)</item> <p></p> <item> Active control group received TAU.</item> </ulist> <p>Active control group was chosen for ethical concerns.</p> <hd id="AN0137441304-7">Population</hd> <p>All consecutive children attending the CGC, aged between 2 and 6 years, fulfilling diagnostic criteria for ASD according to DSM 5, with the presence of a caregiver willing to deliver interventions on a home-basis were considered eligible for participation. Children with comorbid developmental disorders as ADHD, epilepsy and intellectual disability were also included, to make the sample representative of the clinical population. Children with auditory and visual impairment were excluded. Written informed consent was obtained from the parents. Informed consent for telephonic contact for follow up reminders was also taken.</p> <hd id="AN0137441304-8">Randomization and Blinding</hd> <p>Following diagnostic ascertainment and baseline assessments, children were randomized to two groups, the Intervention group (n = 26) and active control group (n = 24) (Fig. 1).</p> <p>Graph: Fig. 1CONSORT trial profile</p> <p>Allocation of participants by simple randomization was based on predetermined computer-generated random numbers. The allocation sequence was generated by PK and serially numbered opaque sealed envelope technique was used for allocation concealment. Following eligibility screening and consent from the caregiver, a unique number from the opaque sealed envelope was used to assign participants to the treatment arms. Participant assignment was done by PK based on random sequence, and the same was concealed from the therapist (HM) to avoid allocation bias. The interventions being behavioral, neither the therapist nor the participating families could be blinded. The baseline research assessments, intervention delivery, and outcome assessments were done by the therapist (HM). Randomized children received intervention according to the allocated arm throughout the study period.</p> <p>The study was approved by Institute research monitoring and ethics committee, and registered under Clinical trials registry, India (Trial Registration Number: CTRI/2017/05/008672). This study was done as a part of postgraduate dissertation in a non-funded government institute in India.</p> <hd id="AN0137441304-9">Study Intervention: Parent-Mediated Intervention for Children with ASD</hd> <p></p> <hd id="AN0137441304-10">Rationale and Components</hd> <p>The study intervention focuses on joint attention skills, to address ASD-specific core deficits, as early as the point of diagnosis. The components of the intervention include joint attention, verbal and motor imitation, social engagement and adaptive skill training. The components are based on the principles of Naturalistic Developmental Behavioral Interventions (NDBI) and the theoretical underpinnings of core deficits in ASD. Joint attention is an early socio-communicative behavior that involves two people actively sharing attention or using gestural communication with respect to an object or event (Jones and Carr [<reflink idref="bib22" id="ref36">22</reflink>]). Lack of development of joint attention, more importantly as a function of social motivation, is an early feature of ASD and is a core deficit unique to children with ASD. Theoretically, impairment in joint attention also contributes to other core deficits in ASD such as impairment in social interaction and language development (Baldwin [<reflink idref="bib3" id="ref37">3</reflink>]). Studies focusing on joint attention based interventions in children with ASD report positive changes in collateral non-target social and communication behaviors and have recommended joint attention as a pivotal component of the early intervention (Kasari et al. [<reflink idref="bib25" id="ref38">25</reflink>]; Whalen et al. [<reflink idref="bib47" id="ref39">47</reflink>]).The principles of NDBI involve teaching developmentally appropriate and prerequisite skills in a naturalistic environment, using family-friendly behavioral strategies, and a strong emphasis on home-based parent-mediated component (Ingersoll and Schreibman [<reflink idref="bib21" id="ref40">21</reflink>], Schreibman et al. [<reflink idref="bib44" id="ref41">44</reflink>]).</p> <p>The intervention components also represent the skill deficits identified in children at-risk for ASD, on assessments using screening instruments like Modified Checklist for Autism in Toddlers (M-CHAT) (Robins et al. [<reflink idref="bib40" id="ref42">40</reflink>]). The components aim to address proximal socio-communicative skill deficits as part of early behavioral intervention, and it meets the age-related developmental demands of the study population. While modules developed in high-income countries predominantly focus on joint attention and communication skills, focus on adaptive skill training is a unique need in our setting (Karanth et al. [<reflink idref="bib24" id="ref43">24</reflink>]). Hence, systematic training of adaptive skills based on the child's current developmental level is also included.</p> <hd id="AN0137441304-11">Structure</hd> <p>The intervention was structured to be delivered on a one–one basis over five sessions (including research assessments, interventions, and follow-up) during outpatient visits, by the principal investigator (HM) to the parents (Harshini and Preeti [<reflink idref="bib18" id="ref44">18</reflink>]). The brevity and outpatient-based delivery were planned to suit the needs of our patient population and the existing healthcare system. The research assessments and intervention were scheduled during the routine outpatient visits, to avoid additional burden to participating families.</p> <p></p> <ulist> <item> Visit 1 and 2: Pre-intervention assessment, educating parents and addressing stress from a cultural perspective</item> <p></p> <item> Visit 1 through 3: Intervention</item> <p></p> <item> Visit 3, 4 and 5: Follow-up, review of intervention and ongoing support</item> </ulist> <p>Parental education, pre-intervention assessment and parent training for intervention delivery were completed from visits one to three. The content of the sessions were kept flexible and overlap was allowed and tailored to the concurrent level of understanding of the disorder, parental stress and coping, mastery of techniques and needs of the individual participants.</p> <p>The components and structure of the intervention are described in detail in the attached supplement.</p> <hd id="AN0137441304-12">Control Group: Components of Treatment as Usual (TAU)</hd> <p>Most children with autism and other developmental disorders are being treated by pediatricians or primary care physicians. In our center, which is a tertiary care setting, the treating team comprises of pediatrician, psychiatrist, speech and occupational therapist. Commonly, treatment as usual involves monthly visits to the treating doctor. Referral for speech and language interventions and occupational therapy are initiated and pharmacological intervention for comorbidities are considered on a case–case basis. Most children presenting to primary care settings receive non-specific interventions or no treatment at all.</p> <p>Children in the intervention arm received parent-mediated intervention in addition to the treatment-as-usual.</p> <hd id="AN0137441304-13">Measures Used</hd> <p>All children and parents were assessed at baseline and the end of 4, 8 and 12 weeks of intervention using the following measures.</p> <hd id="AN0137441304-14">Childhood Autism Rating Scale (CARS)</hd> <p>The Childhood Autism Rating Scale is a 15-item, clinician-rated scale (Schopler et al. [<reflink idref="bib43" id="ref45">43</reflink>]). The components represent the core deficits in ASD, and the total score provides an estimate of autism symptom severity. CARS has been used in Indian children for diagnostic purposes with good reliability and validity, as well as for monitoring symptom severity (Nair et al. [<reflink idref="bib30" id="ref46">30</reflink>]; Russell et al. [<reflink idref="bib42" id="ref47">42</reflink>]).</p> <hd id="AN0137441304-15">Vineland Social Maturity Scale</hd> <p>The Vineland social maturity scale (VSMS) is a clinician-rated tool to assess social and adaptive behavior, developed by Edgar Doll (Doll [<reflink idref="bib11" id="ref48">11</reflink>]). VSMS was used to assess comorbid intellectual disability.</p> <hd id="AN0137441304-16">Family Interview for Stress and Coping (FISC)</hd> <p>The family interview for stress and coping (FISC) (Girimaji et al. [<reflink idref="bib16" id="ref49">16</reflink>]) is a semi-structured, clinician-rated instrument, developed to systematically elicit and quantify perceived stress, mediators of stress and coping strategies in the families of children with developmental disorders. The instrument measures various domains of stress such as daily care stress, personal distress, social and final concerns, and mediators of stress such as awareness regarding the disorder, attitudes, and expectations from the child, rearing practices and overall family adaptation. Higher scores represented higher levels of perceived stress, lack of awareness and maladaptive coping strategies. The severity of stress is shown to correlate with the level of coping strategies. FISC was developed and validated in the Indian population and was chosen for its cultural relevance. In addition to objective assessment, the instrument also helps to formulate individualized family-focused interventions.</p> <hd id="AN0137441304-17">10 Point Visual Analog Scale for Parental and Child-Related Outcome Measures</hd> <p>As standardized rating scales often fail to capture micro-gains, subjective rating on a 10-point visual analog scale was used to rate the parent's and clinician's perception of child's response on the various intervention components such as joint attention, imitation, social as well as adaptive skills, at each visit. Parental subjective distress, understanding of the disorder, intervention techniques and perceived competence to implement interventions were also measured. Structured tools assessing joint attention components in specific were not used in the current study due to lack of open-access.</p> <hd id="AN0137441304-18">Fidelity of Intervention and Implementation</hd> <p>Fidelity of intervention (Appendix 1) was monitored using a checklist completed by the therapist during each visit, and fidelity of implementation of interventions (Appendix 2) was monitored using a simple home log coded by parents. The study being non-funded and conducted in a LAMIC setting; fidelity measures were monitored using checklists only. Audio–video recordings were not used due to logistic and socio-cultural limitations.</p> <p>All the above standardized rating scales have been used in clinical and research settings in the Indian population (Girimaji et al. [<reflink idref="bib16" id="ref50">16</reflink>]; Russell et al. [<reflink idref="bib42" id="ref51">42</reflink>]). Subjective rating scales and fidelity measures were devised appropriate to the intervention and the sociocultural and educational background of the population being studied.</p> <hd id="AN0137441304-19">Outcome Measures</hd> <p></p> <hd id="AN0137441304-20">Primary Outcome Measures</hd> <p>Parental stress and coping assessed on FISC at baseline, 4 weeks, 8 weeks and 12 weeks, parental report of subjective unit of distress, understanding and competence.</p> <hd id="AN0137441304-21">Secondary Outcome Measures</hd> <p>Autism symptom severity assessed on CARS at baseline, 4 weeks, 8 weeks and 12 weeks.</p> <p>Fidelity of intervention and implementation measures</p> <hd id="AN0137441304-22">Statistical Analysis</hd> <p></p> <hd id="AN0137441304-23">Sample Size</hd> <p>The sample size was calculated based on a previous study, which assessed efficacy of parent-mediated interventions (Kasari et al. [<reflink idref="bib26" id="ref52">26</reflink>]). The study had demonstrated 9.7 points difference on a measure of joint attention between the groups over 12 months. Assuming that the change was linear over time, there would be a difference of 2.4 at the end of 3 months. Including 20% drop-outs at the end of 3 months, 5% precision, 80% power and 95% Confidence interval, the sample size was estimated to be 25 in each group to demonstrate a similar difference.</p> <p>All statistical analysis were carried out using IBM PASWSTATISTICS Version 19.0 (SPSS 19.0). Statistical analysis was undertaken according to a pre-specified analysis plan at 12 weeks endpoint of intervention. Categorical variables are represented as frequencies and percentages and continuous variables as means and standard deviations or median and inter-quartile range for parametric and non-parametric distribution respectively. Comparison of categorical variables between groups was done using Chi square or Fisher's exact test and continuous variables by independent samples <emph>T</emph> test or Mann–Whitney <emph>U</emph> test based on distribution.</p> <p>Analysis of treatment effects was done on intent to treat basis. Attending a minimum of 4 out of 5 sessions was pre-considered to show intervention effects and to include for intent to treat analysis. Last observation was carried forward in case of lost to follow-up. There was no missing data across the outcome measures, apart from those who dropped out.</p> <p>Primary and secondary outcome measures: Analysis of parental stress and coping scores measured on Family Interview for Stress and Coping (FISC) and child's autism severity on Childhood Autism Rating Scale (CARS) at the 4-time points (baseline, 4 weeks, 8 weeks and 12 weeks) within the subjects over time and between the two intervention groups were done using repeated measures two-way Analysis of Variance (RM- ANOVA), the intervention effect sizes represented as partial-eta squared. The fidelity measures, feasibility and acceptability of the intervention and implementation were represented as summary statistics.</p> <p>Bivariate Pearson's correlation was done to assess the correlation between outcome measures and the parental, child and intervention variables. All tests are two-tailed and p-value of < 0.05 was considered significant.</p> <hd id="AN0137441304-24">Results</hd> <p>Figure 1 shows the CONSORT diagram and trial profile. The socio-demographic and clinical profiles of the children in both groups are comparable at baseline (Table 1). The mean age of the children in the intervention group was 42.6 (± 17.5) months and 40.1 (± 17.1) months in the control group. The variables such as autism severity, parental stress, educational status of parents, other concurrent interventions and comorbidities were comparable between the two groups (Table 1).</p> <p>Socio-demographic and clinical profile</p> <p> <ephtml> <table frame="hsides" rules="groups"><thead><tr><th align="left"><p>Socio-demographic and clinical profile</p></th><th align="left"><p>Intervention (n = 26)</p><p>Mean (SD)/n (%)</p></th><th align="left"><p>Control (n = 24)</p><p>Mean (SD)/n (%)</p></th><th align="left"><p>Comparison (p value)</p></th></tr></thead><tbody><tr><td align="left"><p>Age (in months)</p></td><td align="left"><p>42.6 (17.5)</p></td><td align="left"><p>40.1 (17.1)</p></td><td align="left"><p>T = 0.506 (0.615)</p></td></tr><tr><td align="left"><p>Sex</p></td><td align="left" /><td align="left" /><td align="left" /></tr><tr><td align="left"><p> Male</p></td><td align="left"><p>22 (84.6)</p></td><td align="left"><p>20 (83.3)</p></td><td align="left" rowspan="2"><p>0.601</p></td></tr><tr><td align="left"><p> Female</p></td><td align="left"><p>4 (15.3)</p></td><td align="left"><p>4 (16.7)</p></td></tr><tr><td align="left"><p>Educational status of primary care giver (no of years of schooling)</p></td><td align="left"><p>13 (4.2)</p></td><td align="left"><p>12.71 (3.4)</p></td><td align="left"><p>T = 0.264 (0.793)</p></td></tr><tr><td align="left"><p>Socioeconomic status</p></td><td align="left" /><td align="left" /><td align="left" /></tr><tr><td align="left"><p> Low</p></td><td align="left"><p>4 (15.3)</p></td><td align="left"><p>7 (29.1)</p></td><td align="left" /></tr><tr><td align="left"><p> Middle</p></td><td align="left"><p>12 (46.1)</p></td><td align="left"><p>7 (29.1)</p></td><td align="left"><p>ƛ<sup>2</sup> = 2.057</p></td></tr><tr><td align="left"><p> High</p></td><td align="left"><p>10 (38.4)</p></td><td align="left"><p>10 (41.6)</p></td><td align="left"><p>(0.357)</p></td></tr><tr><td align="left" rowspan="2"><p>Autism severity (baseline CARS total score)</p></td><td align="left" rowspan="2"><p>35.42 (2.7)</p></td><td align="left" rowspan="2"><p>36 (4.3)</p></td><td align="left"><p>T = 0.550</p></td></tr><tr><td align="left"><p>p = 0.585</p></td></tr><tr><td align="left"><p>Comorbidities</p></td><td align="left" /><td align="left" /><td align="left" /></tr><tr><td align="left" rowspan="2"><p> ADHD</p></td><td align="left" rowspan="2"><p>11</p></td><td align="left" rowspan="2"><p>9</p></td><td align="left"><p>ƛ<sup>2</sup> = 2.204</p></td></tr><tr><td align="left"><p>p = 0.138</p></td></tr><tr><td align="left" rowspan="2"><p> Intellectual disability</p></td><td align="left" rowspan="2"><p>8</p></td><td align="left" rowspan="2"><p>9</p></td><td align="left"><p>ƛ<sup>2</sup> = 0.252</p></td></tr><tr><td align="left"><p>p = 0767</p></td></tr><tr><td align="left"><p> Seizure disorder</p></td><td align="left"><p>4</p></td><td align="left"><p>8</p></td><td align="left"><p>0.767</p></td></tr><tr><td align="left" rowspan="2"><p> Baseline parental stress and coping (total FISC score)</p></td><td align="left" rowspan="2"><p>12.46 (5.4)</p></td><td align="left" rowspan="2"><p>12.54 (5)</p></td><td align="left"><p>T = 0.043</p></td></tr><tr><td align="left"><p>P = 0.966</p></td></tr></tbody></table> </ephtml> </p> <hd id="AN0137441304-25">Services Utilized Outside of the Study Intervention: TAU</hd> <p>The ongoing interventions outside the study intervention, as part of TAU, was found to be comparable between the two groups. Speech and language therapy was attended by 19 (73%) children in the intervention group and 12 (50%) children in the TAU group for an average of 0.5 h per week. Occupational therapy was attended by 12 children in each group (46% in the intervention and 50% in the TAU group), for an average of 0.5 h per week. Among the families, 14 (54%) children in the intervention group and 15 (62%) in the TAU group attended mainstream schools, while 3 children in each group attended special schools. No ASD specific interventions were offered in the mainstream schools as well as special schools during the intervention period. Pharmacotherapy for comorbidities was required in 17 (65%) and 16 (67%) of children in the intervention and TAU group respectively.</p> <hd id="AN0137441304-26">Acceptability, Feasibility and Fidelity Measures</hd> <p>About 94% (n = 47) families attended at least 4 out of 5 sessions, and 86% (n = 43) families attended all the 5 sessions of intervention. The attrition rate was 6%, representing a high level of motivation in the participating families. Only 8% of families required reminders when they missed the scheduled follow-up appointments. About 73% of the families preferred home-based behavioral interventions, 25% preferred combination of pharmacotherapy and behavioral interventions, and only 2% preferred pharmacotherapy as a stand-alone treatment modality for their children. High retention rates and parental preference for behavioral interventions indicate acceptability of the intervention in our setting.</p> <p>High therapist fidelity was noted, all components of the intervention monitored on the checklist was delivered to 92% (n = 46) the families. In 8% families, few intervention targets were not delivered given the concurrent developmental abilities, comorbid disorders, and parental stress. Most parents adhered to the behavioral prescription for home program and were able to implement the number of targets prescribed during each session, using appropriate strategies and techniques. The adherence and duration of interventions improved over time with comfort and mastery of techniques as per the parental report. The number of hours of home-based interventions was 8.37 (± 4.76) hours per week in the intervention group and 2.75 (± 1.56) hours per week in the control group. Three families reported difficulty in implementation of the home-based interventions due to comorbid ADHD, and two families due to personal distress and lack of social support, while none reported difficulty in understanding of the components and techniques of delivery. Report of parental satisfaction and perceived usefulness of the intervention was collected as part of participant feedback at the end of the 12 weeks program. 90% (n = 45) of families reported satisfaction with the parent-mediated intervention for their children.</p> <hd id="AN0137441304-27">Parental Stress and Coping</hd> <p>A significant difference was observed in the reduction of parental stress (F = 3.728, p = 0.026, ES = 0.072) and enhancement of coping (F = 9.508, p = 0.001, ES <bold>η</bold><sups><bold>2</bold></sups>= 0.165), as measured on FISC, from baseline to 12 weeks and in favor of the intervention group, with small effect size (Table 2) (Fig. 2). The total scores of parental stress was found to have a positive correlation with the total scores on coping strategies both at baseline (r = 0.381, p = 0.006) and at 12 weeks (r = 0.368, p = 0.008). On FISC, most parents reported higher levels of stress related to daily care demands and moderate levels personal distress, while social and financial concerns were reported only by few families (n = 2). Parental subjective measures such as reduction in subjective unit of distress (F = 17.72, p < 0.001, ES <bold>η</bold><sups><bold>2</bold></sups>= 0.27), and improvement in understanding of the disorder, intervention techniques and perceived competence (F = 3.276, p = 0.047, ES <bold>η</bold><sups><bold>2</bold></sups>= 0.064) were statistically significant in favor of intervention group, with small effect size.</p> <p>Parental stress and coping on FISC</p> <p> <ephtml> <table frame="hsides" rules="groups"><thead><tr><th align="left" colspan="2"><p>Parental stress and coping total scores on FISC</p></th><th align="left"><p>Intervention</p><p>(n = 26)</p><p>Mean (SD)</p></th><th align="left"><p>Control</p><p>(n = 24)</p><p>Mean (SD)</p></th><th align="left"><p>Time effect (p)</p><p>ES (η<sup>2</sup>)</p></th><th align="left"><p>Time* group effect (p)</p><p>ES (η<sup>2</sup>)</p></th></tr></thead><tbody><tr><td align="left" rowspan="4"><p>Perceived stress in the families</p></td><td align="left"><p>Baseline</p></td><td char="(" align="char"><p>12.46 (6.95)</p></td><td char="(" align="char"><p>12.54 (6.07)</p></td><td align="left" rowspan="4"><p>F = 4.971</p><p>(0.008)*</p><p>ES = 0.094</p></td><td align="left" rowspan="4"><p>F = 3.728</p><p>(0.026)*</p><p>ES = 0.072</p></td></tr><tr><td align="left"><p>Week 4</p></td><td char="(" align="char"><p>11.81 (6.59)</p></td><td char="(" align="char"><p>12.46 (6.07)</p></td></tr><tr><td align="left"><p>Week 8</p></td><td char="(" align="char"><p>10.38 (6.4)</p></td><td char="(" align="char"><p>12.46 (6.1)</p></td></tr><tr><td align="left"><p>Week 12</p></td><td char="(" align="char"><p>10.65(6.2)</p></td><td char="(" align="char"><p>12.29 (6.19)</p></td></tr><tr><td align="left" rowspan="4"><p>Coping strategies</p></td><td align="left"><p>Baseline</p></td><td char="(" align="char"><p>20.27 (3.7)</p></td><td char="(" align="char"><p>20.21 (3.8)</p></td><td align="left" rowspan="4"><p>F = 51.36</p><p>(< 0.001)*</p><p>ES = 0.51</p></td><td align="left" rowspan="4"><p>F = 9.508</p><p>(0.001)*</p><p>ES = 0.165</p></td></tr><tr><td align="left"><p>Week 4</p></td><td char="(" align="char"><p>19.65 (3.3)</p></td><td char="(" align="char"><p>20.08 (3.8)</p></td></tr><tr><td align="left"><p>Week 8</p></td><td char="(" align="char"><p>18.38 (3.7)</p></td><td char="(" align="char"><p>19.67 (3.8)</p></td></tr><tr><td align="left"><p>Week 12</p></td><td char="(" align="char"><p>16.46 (3.9)</p></td><td char="(" align="char"><p>18.71 (4.2)</p></td></tr></tbody></table> </ephtml> </p> <p>Effect size calculated as partial eta squared</p> <p>Graph: Fig. 2Perceived stress and coping strategies—change in FISC scores from baseline to 12 weeks</p> <p>Stress and competence can have a bidirectional effect. To understand this relationship, post hoc comparison of parental stress and competence at each time point was done. A significant difference in the reduction of parental distress was observed in the initial 4 weeks (MD = 0.849, 95% CI 0.183–1.516, p = 0.006), while competence improved significantly after 8 weeks (MD = − 0.941, 95% CI − 1.6 to − 0.242, p = 0.003) and continued to improve at the end of 12 weeks (MD = − 1.095, 95% CI − 1.84 to − 0.34, p = 0.001).</p> <hd id="AN0137441304-28">Autism Severity</hd> <p>Significant difference was found in the reduction of CARS total score at the end of 12 weeks in favor of the intervention group (F = 9.733, p = 0.001, ES <bold>η</bold><sups><bold>2</bold></sups>= 0.169), with small effect size (Fig. 3). It was interesting to note that children showed significant improvement in relating to people, imitation skills, visual response (p < 0.001), listening response (p = 0.015) and non-verbal communication (p = 0.007) over a short term of 12 weeks. These were the skills specifically targeted in the current intervention. Higher order skills such as verbal communication (p = 0.290) and object engagement (p = 0.261) did not show significant change.</p> <p>Graph: Fig. 3Reduction in autism severity—change in CARS scores from baseline to 12 weeks</p> <p>Table 3 shows the correlations of outcome measures with parent-related, child-related and intervention variables. Reduction in parental stress at the end of 12 weeks was found to have positive correlations with baseline parental stress and improvement in parental understanding and competence at the end of 12 weeks. Parents with higher stress at baseline had more change at the end of the interventions, where as families with less baseline stress had lesser numerical difference. Parental stress at 12 weeks did not have correlations with severity of the child's developmental disorder as well as number of hours of home-based interventions.</p> <p>Correlates of outcome measures</p> <p> <ephtml> <table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="2"><p>Correlates of outcome measures</p></th><th align="left"><p>Parental stress and coping at 12 weeks</p></th><th align="left"><p>Autism severity at 12 weeks</p></th></tr><tr><th align="left"><p>Pearson's correlation (r) (p value)</p></th><th align="left"><p>Pearson's correlation (r) (p value)</p></th></tr></thead><tbody><tr><td align="left"><p>Intervention related</p></td><td align="left" /><td align="left" /></tr><tr><td align="left"><p> 1. Number of hours of parent mediated interventions</p></td><td char="(" align="char"><p>0.196 (0.172)</p></td><td char="(" align="char"><p>0.445 (0.001)*</p></td></tr><tr><td align="left"><p> 2. Number. of sessions attended</p></td><td char="(" align="char"><p>0.039 (0.787)</p></td><td char="(" align="char"><p>0.330 (0.020)*</p></td></tr><tr><td align="left"><p>Parent- related variables</p></td><td align="left" /><td align="left" /></tr><tr><td align="left"><p> 1. Perceived stress at baseline</p></td><td char="(" align="char"><p>0.324 (0.022)*</p></td><td char="(" align="char"><p>− 0.071 (0.629)</p></td></tr><tr><td align="left"><p> 2. Parental understanding and competence at Week 12</p></td><td char="(" align="char"><p>0.251 (< 0.001)*</p></td><td char="(" align="char"><p>0.311 (0.030)*</p></td></tr><tr><td align="left"><p>Child- related variables</p></td><td align="left" /><td align="left" /></tr><tr><td align="left"><p> 1. Baseline autism severity</p></td><td char="(" align="char"><p>0.268 (0.060)</p></td><td char="(" align="char"><p>− 0.109 (0.458)</p></td></tr><tr><td align="left"><p> 2. Baseline adaptive functioning</p></td><td char="(" align="char"><p>− 0.051 (0.725)</p></td><td char="(" align="char"><p>− 0.003 (0.984)</p></td></tr><tr><td align="left"><p> 3. Severity of comorbid ADHD</p></td><td char="(" align="char"><p>0.103 (0.477)</p></td><td char="(" align="char"><p>0.017 (0.907)</p></td></tr></tbody></table> </ephtml> </p> <p>Changes in CARS total score was found to have positive correlations with the number of hours of intervention as well as parental understanding and competence. Improvement in autism severity did not have correlations with parental stress and severity of autism and comorbid developmental disorders.</p> <hd id="AN0137441304-29">Discussion</hd> <p>This is one of the few studies evaluating the feasibility and acceptability of ASD-specific behavioral interventions in the Indian settings. The study tests the delivery of ASD-specific intervention components in an outpatient parent-mediated model in the resource-limited settings. Addressing parental stress from a socio-cultural perspective is a unique aspect of this study. This study adds to the evidence for parent-mediated interventions in ASD in the LAMIC settings.</p> <p>High fidelity of intervention and implementation was observed in the current study. Parental adherence and retention rates were high. The use of the checklist for therapist and daily log for parents could have facilitated the process. Though the intervention components are simple, tested and evidence-based, fine-tuning of the intervention delivery methods to the cultural sensitivities and needs of the Indian families could have been pivotal in the acceptability and feasibility of the intervention (Supplementary material).</p> <p>Most parents have reported improvement in perceived stress and coping at the end of 12 weeks of intervention, with a significant difference in favor of parent-mediated intervention group. Similar results have been found in studies by (Rogers et al. [<reflink idref="bib41" id="ref53">41</reflink>]; Wong and Kwan [<reflink idref="bib48" id="ref54">48</reflink>]), where brief parent-mediated interventions (12 weeks) was found to improve parental stress significantly. Though the parental stress and coping was assessed on a subjective measure, as well as objective clinician-rated assessment, the lack of independent outcome assessment is an important limitation. There are very few studies which have systematically looked into parental stress and coping in the context of parent-mediated interventions (Oono et al. [<reflink idref="bib31" id="ref55">31</reflink>]). Parental stress in autism interventions has been examined across several angles, including (<reflink idref="bib1" id="ref56">1</reflink>) whether involving parents as the therapist can increase parental stress and (<reflink idref="bib2" id="ref57">2</reflink>) whether parental stress influence child-related outcomes. Studies on long-term outcomes (1–2 years) have reported no increase in parental stress in the parent-mediated intervention group compared to the TAU group (Aldred et al. [<reflink idref="bib1" id="ref58">1</reflink>]; Drew et al. [<reflink idref="bib12" id="ref59">12</reflink>]; Estes et al. [<reflink idref="bib14" id="ref60">14</reflink>]). In contrast, studies have attributed the failure of intervention effects on child-related outcomes to the lack of consideration and monitoring of parental stress and competence (Oosterling et al. [<reflink idref="bib32" id="ref61">32</reflink>]). Systematic reviews have recommended that monitoring of parental stress is a prerequisite to achieving conclusive evidence on parent-mediated interventions (Oono et al. [<reflink idref="bib31" id="ref62">31</reflink>]).</p> <p>In our study, the parental stress at baseline was predominantly contributed by daily care demands and personal distress as elicited systematically on FISC. The total stress scores being relatively less at baseline could be attributed to the selective nature of the domains affected. Also, some families in the current study reported less or no stress at study entry. In our study, the comparatively lesser levels of stress could be possibly explained by the younger age and mild to moderate severity of ASD in the children, and the relative lack of engagement in other treatment services requiring substantial financial support. Parental stress scores were found to have a positive correlation with total scores on coping strategies. Addressing the reported domains of stress systematically could have possibly improved awareness regarding the disorder, attitudes towards the child and intervention practices. Also, addressing misconceptions and maladaptive child rearing and intervention practices could have in turn mediated in the reduction of parental perceived stress. Though the change in stress scores from baseline to 12 weeks is numerically small, it holds important clinical significance as it could have facilitated active engagement of the parents.</p> <p>Studies have shown a significant changes in child-related measures such as autism severity, joint attention, and dyadic interaction, language and communication skills, adaptive and intellectual functions following parent-mediated interventions. Studies using Autism Diagnostic Observation Schedule (ADOS), have found a significant change in autism severity at the end of 12 months of interventions (Aldred et al. [<reflink idref="bib1" id="ref63">1</reflink>]; Dawson et al. [<reflink idref="bib7" id="ref64">7</reflink>]; Pickles et al. [<reflink idref="bib37" id="ref65">37</reflink>]). Few Asian and Indian studies have used CARS to assess autism severity and have found a significant change in scores by three months of parent-mediated interventions (Juneja et al. [<reflink idref="bib23" id="ref66">23</reflink>]; Pajareya and Nopmaneejumruslers [<reflink idref="bib35" id="ref67">35</reflink>]; Perera et al. [<reflink idref="bib36" id="ref68">36</reflink>]; Wong and Kwan [<reflink idref="bib48" id="ref69">48</reflink>]). Findings of our study are in line with RCTs conducted in similar settings.</p> <p>In the current study, the intervention components primarily focused on joint attention, imitation and social engagement and improvement has been noted in these proximal measures within 12 weeks. Considering the enduring nature of symptoms in ASD and the brief duration of intervention in the current study, the small numerical changes in the total CARS score reflecting the improvement in proximal socio-communicative skills holds clinical significance. Longer follow-up and more intensive interventions are required to achieve substantial gains in higher order skills such as language and communication and substantial reduction in autism symptom severity.</p> <p>Stress and competence could have a bidirectional effect. In the current study, reduction in parental stress was seen in the initial 4 weeks, while parental competence improved significantly from 8 to 12 weeks. Reduction in stress could have probably increased parental engagement in interventions, thereby improving competence. More engagement and comfort with the learned intervention techniques also could have contributed to increased competence, as parents gain mastery over time. Also, improvement in perceived competence and the ability to skillfully contribute to their child's treatment process probably could have contributed to the reduction in parental stress in turn.</p> <p>In addition to intervention-related factors, child and parent-related factors have been found to influence outcomes in parent-mediated interventions independently (Hastings and Johnson [<reflink idref="bib19" id="ref70">19</reflink>]). Studies have shown that the severity of parental stress is influenced by the severity of ASD, level of adaptive functioning and severity of comorbid developmental disorders. In the current study, parental stress and coping at the end of the intervention was found to have positive correlations with the severity of perceived stress at baseline and the improvement in understanding and competence at the end of 12 weeks. The change in stress scores did not have correlations with baseline child-related variables.</p> <p>Studies have shown that children with younger age and milder symptom severity show better improvement with interventions (Fein et al. [<reflink idref="bib15" id="ref71">15</reflink>]). Children with better adaptive functioning, cognitive abilities and lesser object-related engagement at baseline were found to benefit better from parent-mediated interventions (Ben-Itzchak and Zachor [<reflink idref="bib4" id="ref72">4</reflink>]). Many studies have reported more hours of interventions resulted in better child-related outcomes (Linstead et al. [<reflink idref="bib28" id="ref73">28</reflink>]). In the current study, the number of sessions, hours of interventions and parental competence had a positive correlation with change in CARS score. The baseline child and parental characteristics did not have correlations with parental and child outcome measures. Improvement in child-related outcomes was found to be influenced only by intervention-related variables irrespective of the child's age, the severity of autism, parental education and socioeconomic status. This finding should be interpreted in the background of the limitation that the improvement in ASD severity is a parent reported measure.</p> <hd id="AN0137441304-30">Strengths</hd> <p>Our study is one among the few RCTs on parent-mediated intervention in children with Autism in the Indian settings. Incorporating socio-cultural aspects in the intervention design, addressing parental stress, ensuring fidelity of intervention and implementation, applicability and generalizability to resource-limited outpatient settings, and low attrition rates are the strengths. The study has attempted to address the paucity of systematically tested ASD-specific intervention deliverable by parents, across educational and socio-economic barriers.</p> <hd id="AN0137441304-31">Limitations</hd> <p>Lack of independent blind assessor for the primary outcome and fidelity measures is a significant limitation of the study. As the study was part of the postgraduate dissertation, both the intervention delivery and the outcome assessments were conducted by the therapist. Ethical concerns limit having a control group with no treatment, a limitation discussed by most RCTs on ASD behavioral interventions. Gold standard, structured instruments were not used for diagnostic ascertainment, due to lack of open access and affordability in the resource-limited setting. Longer follow-up period is required to demonstrate substantial gains in child-related outcomes. More high-quality, methodologically rigorous RCTs are required to test the efficacy of ASD interventions in LAMIC settings.</p> <hd id="AN0137441304-32">Conclusion</hd> <p>Educating parents and empowering them with parent-mediated interventions in the initial phase of diagnosis helps to improve parental stress, enhance coping and perceived competence. A strong understanding of the issues of relevance to the local community emerges from the clinical experience of working with families and helps in developing culturally-relevant, low-cost programs, with feasibility and acceptability.</p> <p>Parent-mediated interventions deliverable at the first contact can help in addressing the delay in initiation of interventions, and prepare the family for more comprehensive center-based interventions. 'Professional-as-consultant' and 'Parent-as-therapist' model can bridge the existing gap in the healthcare system.</p> <p>This study adds to the limited existing literature on ASD interventions from the non-funded LAMIC settings. There is a need for methodologically rigorous RCTs to establish efficacy of parent-mediated interventions in low-income countries.</p> <hd id="AN0137441304-33">Funding</hd> <p>No funding. Research conducted in a non-funded government hospital in a low-resource setting.</p> <hd id="AN0137441304-34">Acknowledgments</hd> <p>The authors thank Prof Dr. Shoba Srinath and Prof Dr. Satish Chandra Girimaji, Department of Child and Adolescent Psychiatry, NIMHANS, Bangalore, India for their expert review of the intervention. We also thank Prof Dr. Mahadevan Subramanian, Department of Pediatrics, JIPMER, Puducherry, India, for his valuable contribution to the design of the study.</p> <hd id="AN0137441304-35">Author Contributions</hd> <p>HM is the principal investigator, involved in data collection, intervention delivery and manuscript preparation. PK conceptualized the study design, developed the intervention, contributed to drafting the manuscript and approved the final version. VC participated in the design and coordination of the study and interpretation of the data. RP contributed to intellectual content and approved the manuscript. All authors read and approved the final manuscript.</p> <hd id="AN0137441304-36">Compliance with Ethical Standards</hd> <p></p> <hd id="AN0137441304-37">Conflict of interest</hd> <p>All authors declared that they have no competing interest.</p> <hd id="AN0137441304-38">Electronic supplementary material</hd> <p>Graph: Supplementary material 1 (DOCX 34 kb)</p> <hd id="AN0137441304-39">Publisher's Note</hd> <p>Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.</p> <ref id="AN0137441304-40"> <title> References </title> <blist> <bibl id="bib1" idref="ref27" type="bt">1</bibl> <bibtext> Aldred C, Green J, Adams C. A new social communication intervention for children with autism: pilot randomised controlled treatment study suggesting effectiveness. 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  Data: Brief Parent-Mediated Intervention for Children with Autism Spectrum Disorder: A Feasibility Study from South India
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  Data: <searchLink fieldCode="AR" term="%22Manohar%2C+Harshini%22">Manohar, Harshini</searchLink><br /><searchLink fieldCode="AR" term="%22Kandasamy%2C+Preeti%22">Kandasamy, Preeti</searchLink><br /><searchLink fieldCode="AR" term="%22Chandrasekaran%2C+Venkatesh%22">Chandrasekaran, Venkatesh</searchLink><br /><searchLink fieldCode="AR" term="%22Rajkumar%2C+Ravi+Philip%22">Rajkumar, Ravi Philip</searchLink>
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  Data: Springer. Available from: Springer Nature. 233 Spring Street, New York, NY 10013. Tel: 800-777-4643; Tel: 212-460-1500; Fax: 212-348-4505; e-mail: customerservice@springernature.com; Web site: https://link.springer.com/
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  Data: 10.1007/s10803-019-04032-x
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  Data: The study assesses the acceptability and feasibility of a brief parent-mediated home-based intervention for children with autism spectrum disorder (ASD), deliverable in resource-limited settings, with an emphasis on addressing parental stress from a socio-cultural perspective. 50 children (2-6 years), with a DSM 5 diagnosis of ASD were randomized to intervention (n = 26) or active control group (n = 24). The intervention based on naturalistic developmental behavioral approach, focusing on joint attention, imitation, social and adaptive skills was structured to be delivered in five outpatient sessions over 12 weeks. All children were followed up at 4, 8 and 12 weeks. Parents of children randomized to the intervention group reported more improvements across parental stress and child outcome measures compared to those in the control group. The intervention was found to be acceptable and feasible, with high fidelity measures and retention rates.
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