A Brief Parent-based Sleep Intervention for Children With Autism Spectrum Disorder

NCT05010824 | Completed

• 1 other identifier: UW20-204
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

Sleep problems are very common in children with ASD, with a prevalence rate as high as 78%, and often pose significant challenges and stress to the families. Sleep problems in children with ASD are strongly associated with the exacerbation of daytime symptoms, and poor parental sleep quality and mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ASD (aged 3-6). Eligible participants will be randomised to either intervention (three consultation sessions and four follow-up phone calls) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), and one-week after the intervention (post-treatment).

Conditions

ASD; Insomnia

Keywords

Sleep; ASD; Insomnia; Behavioral Intervention

Outcome Measures

Primary Outcomes (4)

• Child: Change of child's sleep

  Change of the child's sleep measured by the Children's Sleep Habits Questionnaire (CSHQ). The total score of CSHQ ranges from 33 to 99. A higher score reflects more sleep disturbance.

  Baseline, immediately after the treatment

• Child: change of insomnia symptoms (bedtime resistance)

  Change of the child's bedtime resistance measured by the Children's Sleep Habits Questionnaire (CSHQ) bedtime resistance score (6 items; score range: 6-18)

  Baseline, immediately after the treatment

• Child: change of insomnia symptoms (sleep onset delay)

  Change of the child's sleep onset delay measured by the Children's Sleep Habits Questionnaire (CSHQ) sleep onset delay score (1 item; score range: 1-3)

  Baseline, immediately after the treatment

• Child: change of insomnia symptoms (night waking)

  Change of the child's night waking measured by the Children's Sleep Habits Questionnaire (CSHQ) night waking score (3 items; score range: 3-9)

  Baseline, immediately after the treatment

Secondary Outcomes (9)

• Parent: Change of parental self-reported sleep quality

  Baseline, immediately after the treatment

• Parent: Change of parental insomnia symptoms

  Baseline, immediately after the treatment

• Child: Change of child's behaviour & other clinical symptoms

  Baseline, immediately after the treatment

• Child: Change of child's executive functions reported by parents

  Baseline, immediately after the treatment

• Parent: Change of parental mood symptoms

  Baseline, immediately after the treatment

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention will involve three consultation sessions and four follow-up phone calls with parents to help them learn sleep hygiene practices and specific behavioural strategies to improve their child's sleep and follow up on the progress.

Behavioral: Sleep hygiene practices and behavioural intervention

Waiting-list control

NO INTERVENTION

Children in the waiting-list control group will receive usual clinical care.

Interventions

Sleep hygiene practices and behavioural intervention BEHAVIORAL

The first session will involve the provision of sleep-related psycho-education (e.g. sleep hygiene practices) and specific strategies to tackle problematic sleep-related behaviours, as well as collaborative goal setting and development of management plan tailored to the child's sleep problem. The second and third session will involve a review of the sleep diary and a reinforcement of learned strategies, and focus on problem-solving to tackle any issues that have emerged from implementing the behavioural strategies at home. Follow-up phone calls provide parents with an opportunity to ask any further questions and to consolidate learned strategies and further troubleshoot.

Intervention group

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parents/caregivers (aged 21 or above) of preschool children (aged 3 to 6 years old) with a clinical diagnosis of ASD attending paediatric developmental clinic or clinical psychology service at the Duchess of Kent Child Assessment Centre (DKCAC)
• Clinical diagnosis of ASD would be made by either a Pediatrician or a Clinical Psychologist, using at least one of the following diagnostic tools: Childhood Autism Rating Scale, Second Edition (CARS-2), Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), Autism Diagnostic Interview-Revised (ADI-R) and clinical interview based on diagnostic criteria of ASD depicted in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).

You may not qualify if:

• \- Parent/caregiver of children with diagnosed co-morbid neurological, psychiatric or medical conditions which could have affected their sleep, such as obstructive sleep apnea, epilepsy, childhood anxiety disorder

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (2)

Department of Clinical Psychology, The Duchess of Kent Children's Hospital at Sandy Bay, HKWC, Hospital Authority

Hong Kong, Hong Kong

Location

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Shirley Xin Li, PhD,DClinPsy

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 18, 2021
• Study Start: August 5, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)