Sleep Intervention in Children With ASD

Официальное название

Effects of Digitally Delivered Parent-based Behavioural Sleep Intervention in Children With Autism Spectrum Disorder (ASD) - A Randomised Controlled Trial

Обзор

The goal of this randomised controlled trial is to examine the following research questions: 1) whether digitally delivered parent-based behavioural sleep intervention with or without personalised support is effective in improving sleep, clinical and daytime symptoms, and 2) whether such interventions can also improve parental sleep, mental health, and parenting stress in children with ASD and insomnia.

Подробное описание

A randomised, assessor-blind, parallel-group controlled trial (RCT) will be conducted in children with ASD and insomnia. Eligible participants will be randomised to one of the following groups: app-based cognitive behavioural therapy for insomnia (CBT-I) with personalised support, app-based CBT-I without personalised support, or treatment-as-usual (TAU). Randomisation will be carried out using an automated online system and stratified by gender. Assessments will be conducted at pre-treatment and post-treatment (1 week after intervention completion). The two active treatment groups will be additionally followed up at post-treatment 3 months and posttreatment 6 months.

Вмешательства

• Поведенческое App-based CBT-I with personalised telephone support
  Participants in this group will be instructed to download a smartphone application. The smartphone app-based intervention, involving six sequential modules, is structured and based on the well-established behavioural sleep intervention elements for managing sleep problems in children, with the consideration of catering to the needs of children with ASD. The main treatment components include: (1) psychoeducation about sleep in the developmental context as well as in the context of ASD, (2) sleep
• Поведенческое App-based CBT-I without personalised telephone support
  Participants in this group will be instructed to download the same smartphone application used in the app-based CBT-I with personalised support. No telephone support will be provided to this group.

Первичные конечные точки

• Child: Change of child's sleep problems [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]

Вторичные конечные точки (12)

• Child: Change of child's ASD symptoms [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]
• Child: Change of child's emotional and behavioural problems [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]
• Child: Change of child's executive function [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]
• Child: Change of child's daytime sleepiness [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]
• Child: Change of child's quality of life [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]
• Child: Change of parent-reported child sleep diary measures [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all consented participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]
• Child: Change of child's actigraphy-based measures [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all consented participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for these participants in the treatment groups.]
• Child: Change of overall severity of child's clinical symptoms [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]
• Parent: Change of parental insomnia symptoms [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]
• Parent: Change of parental sleep quality [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]
• Parent: Change of parental mental health [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]
• Parent: Change of parenting stress [Срок оценки: Baseline, Post-Treatment (1 week after intervention completion) for all participants, and additionally two follow-ups at Post-Treatment 3-month and Post-Treatment 6-month for participants in the treatment groups.]

Критерии участия

Критерии включения

• (1) Parents/caregivers with a child aged 6 to 12 years old, and attending a local mainstream primary school at the time of recruitment;
• (2) The child is diagnosed to have ASD, which will be based on the assessment conducted by a psychiatrist or a clinical psychologist that incorporates the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) assessment criteria, with corroboration by the Autism Diagnostic Interview - Revised (ADI-R);
• (3) The child is reported by the parent/caregiver to have insomnia symptoms, typically a difficulty in falling asleep with or without bedtime resistance, which is operationally defined as sleep onset latency exceeding 25 minutes and occurring three or more times per week. The child's sleep problems have lasted for a minimum of three months and have led to an impairment in the daily functioning of the child and/or parents. Such inclusion criteria are based on the DSM-V criteria for insomnia, with the choice of a 25-minute sleep onset latency criteria based on the normative values reported by Scholle et al.;
• (4) Parent owns and knows how to use smartphones and can comprehend Chinese language;
• (5) The child's parent or guardian gives written informed consent of participation into the study;
• (6) Being able to comply with the study protocol.

Критерии исключения

• (1) Children with diagnosed intellectual disability;
• (2) Children with any diagnosed co-morbid neurological or medical conditions which could have affected their sleep, such as blindness, traumatic brain injury, epilepsy and poorly controlled eczema;
• (3) Children with diagnosed sleep disorders other than insomnia or with suspected sleep apnoea (as assessed by the Children's Sleep Habits Questionnaire (CSHQ): obtaining a score of 4 or above on the sleep-disordered breathing subscale on the CSHQ) that may potentially contribute to a disruption in sleep continuity and quality. Children who are currently receiving regular melatonin treatment, as well as other medications such as Selective Serotonin Reuptake Inhibitors (SSRIs), will be considered for inclusion in the trial if they continue to meet the eligibility criteria.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT07398183 · EA240518

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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