RecruitingNot ApplicableNCT07398183

Sleep Intervention in Children With ASD

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

Sponsor

The University of Hong Kong

Enrollment

195 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Insomnia Autism Spectrum Disorder (ASD)

Summary

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.

Eligibility

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria5

(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);
(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 Criteria3

(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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALApp-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 hygiene education, (3) sleep-focused behavioural strategies (e.g., consistent bedtime routine, bedtime fading, extinction, sleep restriction, use of 'bedtime pass'), (4) relaxation strategies, (5) cognitive restructuring (targeting dysfunctional cognitions) and (6) relapse prevention. A weekly phone call support by a trained therapist, using a semi-structured script, will be provided during the intervention period (around 15 mins each time) to the parents.

BEHAVIORALApp-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.