Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver's Quality of Life.

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Title: Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver's Quality of Life.
Authors: Schroder, Carmen M., Malow, Beth A., Maras, Athanasios, Melmed, Raun D., Findling, Robert L., Breddy, John, Nir, Tali, Shahmoon, Shiri, Zisapel, Nava, Gringras, Paul
Source: Journal of Autism & Developmental Disorders. Aug2019, Vol. 49 Issue 8, p3218-3230. 13p. 5 Charts, 1 Graph, 1 Map.
Subjects: Melatonin, Autism, Psychology of caregivers, Child behavior, Insomnia, Quality of life, Questionnaires, Statistical sampling, Sleep disorders, Randomized controlled trials, Treatment effectiveness, Blind experiment, Evaluation, Children, Therapeutics
Abstract: A randomized, 13-weeks, placebo-controlled double-blind study in 125 subjects aged 2–17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia demonstrated efficacy and safety of easily-swallowed prolonged-release melatonin mini-tablets (PedPRM; 2–5 mg) in improving sleep duration and onset. Treatment effects on child behavior and caregiver's quality of life were evaluated. PedPRM treatment resulted in significant improvement in externalizing but not internalizing behavior (Strengths and Difficulties questionnaire; SDQ) compared to placebo (p = 0.021) with clinically-relevant improvements in 53.7% of PedPRM-treated versus 27.6% of placebo-treated subjects (p = 0.008). Caregivers' quality of life also improved with PedPRM versus placebo (p = 0.010) and correlated with the change in total SDQ (p = 0.0005). PedPRM alleviates insomnia-related difficulties, particularly externalizing behavior in the children, subsequently improving caregivers' quality of life. [ABSTRACT FROM AUTHOR]
Copyright of Journal of Autism & Developmental Disorders is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver's Quality of Life.
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  Data: <searchLink fieldCode="AR" term="%22Schroder%2C+Carmen+M%2E%22">Schroder, Carmen M.</searchLink><br /><searchLink fieldCode="AR" term="%22Malow%2C+Beth+A%2E%22">Malow, Beth A.</searchLink><br /><searchLink fieldCode="AR" term="%22Maras%2C+Athanasios%22">Maras, Athanasios</searchLink><br /><searchLink fieldCode="AR" term="%22Melmed%2C+Raun+D%2E%22">Melmed, Raun D.</searchLink><br /><searchLink fieldCode="AR" term="%22Findling%2C+Robert+L%2E%22">Findling, Robert L.</searchLink><br /><searchLink fieldCode="AR" term="%22Breddy%2C+John%22">Breddy, John</searchLink><br /><searchLink fieldCode="AR" term="%22Nir%2C+Tali%22">Nir, Tali</searchLink><br /><searchLink fieldCode="AR" term="%22Shahmoon%2C+Shiri%22">Shahmoon, Shiri</searchLink><br /><searchLink fieldCode="AR" term="%22Zisapel%2C+Nava%22">Zisapel, Nava</searchLink><br /><searchLink fieldCode="AR" term="%22Gringras%2C+Paul%22">Gringras, Paul</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22Journal+of+Autism+%26+Developmental+Disorders%22">Journal of Autism & Developmental Disorders</searchLink>. Aug2019, Vol. 49 Issue 8, p3218-3230. 13p. 5 Charts, 1 Graph, 1 Map.
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  Data: <searchLink fieldCode="DE" term="%22Melatonin%22">Melatonin</searchLink><br /><searchLink fieldCode="DE" term="%22Autism%22">Autism</searchLink><br /><searchLink fieldCode="DE" term="%22Psychology+of+caregivers%22">Psychology of caregivers</searchLink><br /><searchLink fieldCode="DE" term="%22Child+behavior%22">Child behavior</searchLink><br /><searchLink fieldCode="DE" term="%22Insomnia%22">Insomnia</searchLink><br /><searchLink fieldCode="DE" term="%22Quality+of+life%22">Quality of life</searchLink><br /><searchLink fieldCode="DE" term="%22Questionnaires%22">Questionnaires</searchLink><br /><searchLink fieldCode="DE" term="%22Statistical+sampling%22">Statistical sampling</searchLink><br /><searchLink fieldCode="DE" term="%22Sleep+disorders%22">Sleep disorders</searchLink><br /><searchLink fieldCode="DE" term="%22Randomized+controlled+trials%22">Randomized controlled trials</searchLink><br /><searchLink fieldCode="DE" term="%22Treatment+effectiveness%22">Treatment effectiveness</searchLink><br /><searchLink fieldCode="DE" term="%22Blind+experiment%22">Blind experiment</searchLink><br /><searchLink fieldCode="DE" term="%22Evaluation%22">Evaluation</searchLink><br /><searchLink fieldCode="DE" term="%22Children%22">Children</searchLink><br /><searchLink fieldCode="DE" term="%22Therapeutics%22">Therapeutics</searchLink>
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  Data: A randomized, 13-weeks, placebo-controlled double-blind study in 125 subjects aged 2–17.5 years with Autism Spectrum Disorder or Smith-Magenis syndrome and insomnia demonstrated efficacy and safety of easily-swallowed prolonged-release melatonin mini-tablets (PedPRM; 2–5 mg) in improving sleep duration and onset. Treatment effects on child behavior and caregiver's quality of life were evaluated. PedPRM treatment resulted in significant improvement in externalizing but not internalizing behavior (Strengths and Difficulties questionnaire; SDQ) compared to placebo (p = 0.021) with clinically-relevant improvements in 53.7% of PedPRM-treated versus 27.6% of placebo-treated subjects (p = 0.008). Caregivers' quality of life also improved with PedPRM versus placebo (p = 0.010) and correlated with the change in total SDQ (p = 0.0005). PedPRM alleviates insomnia-related difficulties, particularly externalizing behavior in the children, subsequently improving caregivers' quality of life. [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Journal of Autism & Developmental Disorders is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1007/s10803-019-04046-5
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        Text: English
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        PageCount: 13
        StartPage: 3218
    Subjects:
      – SubjectFull: Melatonin
        Type: general
      – SubjectFull: Autism
        Type: general
      – SubjectFull: Psychology of caregivers
        Type: general
      – SubjectFull: Child behavior
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      – SubjectFull: Insomnia
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      – SubjectFull: Quality of life
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      – SubjectFull: Questionnaires
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      – SubjectFull: Statistical sampling
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      – SubjectFull: Sleep disorders
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      – SubjectFull: Randomized controlled trials
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      – TitleFull: Pediatric Prolonged-Release Melatonin for Sleep in Children with Autism Spectrum Disorder: Impact on Child Behavior and Caregiver's Quality of Life.
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              Text: Aug2019
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