Parent-Mediated Telehealth Intervention for Insomnia in Young Autistic Children

Обзор

This study will evaluate the efficacy of a structured parent-mediated behavioral intervention called Sleep Parent Treatment (SPT) for insomnia in autistic children ages 3 to 7 years 11 months, compared to another behavioral intervention called Sleep Parent Education (SPE). Eligible children will be randomly assigned to either the SPT or SPE intervention for 10 weeks.

Подробное описание

In the general pediatric population, insomnia affects an estimated 20-25% of children, however, insomnia affects as many as 40-80% of children with autism spectrum disorder (ASD).

Insomnia is characterized by problems of initiating sleep and/or maintaining sleep occurring three or more nights per week for more than three months accompanied by distress, impairment or both. The diagnostic criteria stipulate that the sleep problem is not attributable to another cause (e.g., restless legs syndrome, caffeine intake). In autistic children, insomnia may interfere with concentration and learning, may contribute to daytime sleepiness, disruptive daytime behavior, emotion dysregulation and physical injury. The child's bedtime behavior and sleep disturbances may also interfere with sleep for caregivers or other family members and predict elevated parental stress. Chronic insomnia in children may have detrimental effects on cardiovascular, endocrine or immune systems. Parents of autistic children with insomnia consistently report that the child's bedtime resistance behaviors may be difficult to manage.

Accumulated data indicate that parent-mediated behavioral interventions for insomnia can be effective, however, only a few randomized controlled trials have rigorously tested parent-mediated behavioral interventions for insomnia in autistic children. A recently completed telehealth trial compared two behavioral interventions and found that Sleep Parent Treatment (SPT) was superior to Sleep Parent Education (SPE) for improving child sleep outcomes, parental self-efficacy and parental distress. Although encouraging, the sample size of this study provided limited exploration of treatment moderators. The researchers now propose a large-scale, definitive study of telehealth SPT versus individualized, menu-driven SPE.

In this study, autistic children with at least moderate insomnia will be randomly assigned to SPT or SPE for 10 weeks. The primary outcome is the parent-rated PAIRS, a newly validated, continuous measure assessing insomnia severity in children with ASD. It will be collected at baseline, midpoint (Week 5) and endpoint (Week 10) in the randomized phase.

Longitudinal differences in PAIRS between randomized groups will be tested for significance using a general linear mixed effects regression model (GLMM). The GLMM will use data from all study time points and report on the baseline-adjusted least-squares mean (LS-mean) difference in PAIRS at Week 10 for SPT compared to SPE, with 95% confidence interval (CI) and p-value. The researchers will follow intention-to-treat (ITT) principles throughout, analyzing participants according to originally assigned groups, regardless of what treatment they received (if any) or attrition.

Вмешательства

• Поведенческое Sleep Parent Training (SPT)
  Five SPT sessions, each 60-90 minutes in duration, are individually delivered over 10 weeks. Each session employs direct instruction, modeling, and role-playing to promote parental skill acquisition. The SPT manual includes a therapist script and parent activity sheets for each session. Video vignettes for each session model specific techniques, including correct application of a technique and ineffective strategies. To supplement the 5 sessions, three virtual parent-child coaching sessions occu
• Поведенческое Sleep Parent Education (SPE)
  SPE includes five 60-90 minute sessions, delivered individually over 10 weeks. SPE provides useful information to families of young children with ASD and insomnia. The sessions cover a review of autism, sleep hygiene, interpretation of clinical evaluations, child advocacy and evaluation of available treatments, and information on evidence-based treatments.

Первичные конечные точки

• Pediatric Autism Insomnia Scale (PAIRS) Score [Срок оценки: Baseline, Week 5, Week 10]

Вторичные конечные точки (1)

• Rate of Positive Response on the Clinical Global Impression - Improvement (CGI-I) Scale [Срок оценки: Week 10]

Критерии участия

Критерии включения

• Age >3 to 7 years 11 months
• Clinical diagnosis of ASD supported by the Autism Diagnostic Interview Revised (ADI-R)
• Score of 30 or more on the Parent-Rated Insomnia Scale - ASD (PAIRS) and the Clinical Global Impression Severity (CGI-S) score of Moderate or greater (a score of 4 or more)
• Medication and supplement free or on stable medication or supplements (no changes in the past 6 weeks and no planned changes for 10 weeks of the randomized trial)
• Parental proficiency in spoken and written English language. Study materials and many of the study measures are only available in English

Критерии исключения

• Children with a history of serious medical condition or known medical cause insomnia (e.g., nocturnal seizures, unresolved gastrointestinal problems such as reflux or constipation)
• Children with a psychiatric disorder or serious behavioral problem requiring a different treatment
• Children with known sleep apnea, restless leg syndrome, or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome)
• Children of non-English language speaking caregivers will be excluded because study intervention materials and many of the study measures are only available in English

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Emory School Of Medicine — Atlanta
• Case Western Reserve University — Cleveland
• Ohio State University — Columbus

Идентификаторы

NCT: NCT07435740 · 2025P013830 · R01HD114631

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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