Sleep Intervention in Children With ASD | NCT07398183

NCT07398183

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Chinese University of Hong Kong	OTHER

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
App-based CBT-I with personalised telephone support	Experimental	App-based cognitive behavioural therapy for insomnia with personalised telephone support	Behavioral: App-based CBT-I with personalised telephone support
App-based CBT-I without personalised support	Experimental	App-based cognitive behavioural therapy for insomnia without personalised telephone support	Behavioral: App-based CBT-I without personalised telephone support
TAU group	No Intervention	Participants will continue their usual clinical follow-up and receive standard treatment where needed. No app-based intervention and telephone support will be provided to this group.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
App-based CBT-I with personalised telephone support	Behavioral	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Child: Change of child's sleep problems	The Children's Sleep Habits Questionnaire (CSHQ) - parent report is a commonly used measure to assess sleep symptoms in children aged 4-12 years. It consists of 33 items to evaluate a child's sleep behavior over the past week. Items are rated on a 3-point scale to indicate the frequency of each sleep behavior: "usually/five to seven times per week," "sometimes/two to four times per week," and "rarely/zero to once per week." The CSHQ total score is the sum of the 33 questions and ranges from 33 to 99. Higher scores indicate more severe sleep disturbances.	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 Outcomes

Measure	Description	Time Frame
Child: Change of child's ASD symptoms	The Social Communication Questionnaire, Current Form - parent report (SCQ-CF-PR) is a 40-item screening instrument designed to assess social communication deficits and repetitive behavioral patterns associated with autism spectrum disorder (ASD). This scale quantifies autistic characteristics aligned with the three core domains of impairment in ASD: communication, reciprocal social interaction, and restricted, repetitive, and stereotyped (RRS) behaviors. The SCQ-CF-PR yields a total raw score ranging from a minimum of 0 to a maximum of 40 points, with higher scores indicating greater severity of ASD-related social communication and behavioral impairments.

Eligibility Module

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.

ID	Term
D007319	Sleep Initiation and Maintenance Disorders
D000067877	Autism Spectrum Disorder