Clinical trial NCT05010824: A Brief Parent-based Sleep Intervention for Children With Autism Spectrum Disorder
Official title: Effects of Parent-based Educational Programme for Sleep Problems in Children With Autism Spectrum Disorder (ASD): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ASD
Insomnia
Keywords: Sleep
ASD
Insomnia
Behavioral Intervention
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 75
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

- 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

Primary outcomes:
measure: Child: Change of child's sleep
timeFrame: Baseline, immediately after the treatment
measure: Child: change of insomnia symptoms (bedtime resistance)
timeFrame: Baseline, immediately after the treatment
measure: Child: change of insomnia symptoms (sleep onset delay)
timeFrame: Baseline, immediately after the treatment
measure: Child: change of insomnia symptoms (night waking)
timeFrame: Baseline, immediately after the treatment
Secondary outcomes:
measure: Parent: Change of parental self-reported sleep quality
timeFrame: Baseline, immediately after the treatment
measure: Parent: Change of parental insomnia symptoms
timeFrame: Baseline, immediately after the treatment
measure: Child: Change of child's behaviour & other clinical symptoms
timeFrame: Baseline, immediately after the treatment
measure: Child: Change of child's executive functions reported by parents
timeFrame: Baseline, immediately after the treatment
measure: Parent: Change of parental mood symptoms
timeFrame: Baseline, immediately after the treatment
measure: Parent: Change of parental stress
timeFrame: Baseline, immediately after the treatment
measure: Parent: Change of parental sense of competence and satisfactory in parenting
timeFrame: Baseline, immediately after the treatment
measure: Parent: Parent's satisfaction to the treatment
timeFrame: Baseline, immediately after the treatment
measure: Parent: Parent's overall health status
timeFrame: Baseline, immediately after the treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Clinical Psychology, The Duchess of Kent Children's Hospital at Sandy Bay, HKWC, Hospital Authority
city: Hong Kong
country: Hong Kong
facility: Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Shirley Xin Li, PhD,DClinPsy
role: PRINCIPAL_INVESTIGATOR
References: