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Recruiting NCT07398183

Sleep Intervention in Children With ASD

No phase Interventional Insomnia Autism Spectrum Disorder (ASD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: App-based CBT-I with personalised telephone support, App-based CBT-I without personalised telephone support.
Who it may be relevant to
Registry conditions: Insomnia, Autism Spectrum Disorder (ASD). Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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
  • Behavioral 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.

Primary outcome measures

  • Child: Change of child's sleep problems [Time frame: 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.]
Secondary outcome measures (12)
  • Child: Change of child's ASD symptoms [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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.]

Eligibility criteria

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07398183 · EA240518

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗