InsomniaNCT07398183
Sleep Intervention in Children With ASD
A study testing App-based CBT-I with personalised telephone support and App-based CBT-I without personalised telephone support in people with Insomnia and Autism Spectrum Disorder (ASD), run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Insomnia, Autism Spectrum Disorder (ASD)
- What is being tested?
- App-based CBT-I with personalised telephone support and App-based CBT-I without personalised telephone support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
Shirley X Li, 852-39177035, shirley.li@hku.hk
About this study
Official title: Effects of Digitally Delivered Parent-based Behavioural Sleep Intervention in Children With Autism Spectrum Disorder (ASD) - A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Insomnia, Autism Spectrum Disorder (ASD)
- Being tested
- App-based CBT-I with personalised telephone support, App-based CBT-I without personalised telephone support
- Keywords
- insomnia, Autism spectrum disorder, ASD, behavioral sleep intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based CBT-I with personalised telephone supportBehavioural
Also called App-based intervention with personalised 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.
App-based CBT-I without personalised telephone supportBehavioural
Also called App-based intervention without personalised 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.
| Study group | Role | What they receive |
|---|---|---|
| App-based CBT-I with personalised telephone support | Experimental | App-based cognitive behavioural therapy for insomnia with personalised telephone support Receives: 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (15)
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.
Measured: 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
The Strengths and Difficulties Questionnaire (SDQ) - parent report is a 25-item instrument for measuring internalising and externalising problems in children and adolescents. It consists of five domains (emotional symptoms, conduct problems, hyperactivity/inattention, peer problems, and prosocial behaviours), with 5 items each rated on a three-point scale [0 ("not true") to 2 ("certainly true")]. The conduct problem and hyperactivity/inattention domains were grouped under the externalizing problem subscale (range 0-20), while the emotional symptoms and peer problems were grouped under the internalizing problem subscale (range 0-20). The total difficulties score is generated by summing the scores from the four problem scales (excluding Prosocial Behavior), yielding a range from 0 to 40. Higher scores indicate more problems, except that a higher prosocial score indicated better prosocial behaviours.
Measured: 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
The Behavior Rating Inventory of Executive Function, Second Edition (BRIEF2) - Parent Report is a 63-item questionnaire designed to assess executive functioning deficits in children and adolescents across everyday home and community settings. The scale generates nine clinical subscale raw scores and a single Global Executive Composite (GEC) raw score (the primary summary measure of overall executive functioning). All raw scores range from a minimum of 0 to subscale/maximum-specific maximum values (total GEC raw score: 0-189). Higher raw scores indicate greater severity of executive functioning impairments.
Measured: 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
Pediatric Daytime Sleepiness Scale (PDSS) - parent report is an 8-item self-rated scale measuring daytime sleepiness, ranging in total scores from 0 to 32 with higher scores indicating more sleepiness.
Measured: 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
The Pediatric Quality of Life Inventory 4.0 (PedsQL) - parent report is a validated 23-item measure of quality of life for children aged 2 to 18 years. Each item is rated on a 5-point Likert scale from "never" to "almost always" based on the behavior of child in the past month. The scores are transformed on a scale from 0 to 100, with a higher score indicating better quality of life.
Measured: 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
Parent-reported child's daily sleep diary for consecutive seven days. Sleep diary derived parameters include: 1) time in bed (TIB) in hours. 2) total sleep time (TST) in hours. 3) sleep onset latency (SOL) in mins. 4) wake after sleep onset (WASO) in mins. 5) sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %.
Measured: 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
The child's sleep-wake pattern will be objectively measured by 7-day wrist actigraphy. Sleep parameter estimated by actigraphy will include time in bed, total sleep time, sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency.
Measured: 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
Clinical Global Impression (CGI) Scale is a clinician-rated scale, comprised of two one-item subscales: Severity of Illness (CGI-S) subscale evaluating the severity of psychopathology, and Clinical Global Improvement Scale (CGI-I) evaluating change from the initiation of treatment. In both cases, the score is given on a seven-point scale, with higher values indicating higher severity of illness and larger improvement respectively.
Measured: 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
Insomnia Severity Index (ISI) is a 5-item self-rated scale to measure insomnia symptoms. Possible scores range from 0 to 20, with higher scores indicating higher insomnia severity.
Measured: 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
Pittsburgh Sleep Quality Index (PSQI) is a self-rated scale consisting of 19 questions. All items are combined to form seven component scores on different aspects of sleep quality, each of which ranges from 0 to 3 points with higher scores representing more sleep disturbance. The seven component scores are added to one global score, which ranges from 0 to 21, with higher scores indicating more difficulties with sleep.
Measured: 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
Depression Anxiety Stress Scales-21 (DASS-21) consists of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS scales contains 7 items. Each subscale ranges from 0 to 21. Higher scores suggest more depression, anxiety and stress, respectively.
Measured: 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
Parenting Stress Index-Short Form (PSI-SF) is a 36-item self-report measure designed to assess stress in the parent-child relationship, derived from the full Parenting Stress Index. It includes three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (PCDI), and Difficult Child (DC). Each subscale has 12 items rated on a 5-point Likert scale, amounting to a total score that ranges from 36 to 180. Higher scores indicate higher levels of stress in the parent-child relationship.
Measured: 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 quailty of life
The World Health Organisation- Five Well-Being Index (WHO-5) consists of 5 self-report items designed to measure subjective well-being. Each item is rated on a 6-point scale from 0 ("at no time") to 5 ("all of the time"), resulting in a raw score range of 0 to 25. Higher scores indicate better well-being.
Measured: 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 diary measures
Daily sleep diary for consecutive seven days. Sleep diary derived parameters include: 1) time in bed (TIB) in hours. 2) total sleep time (TST) in hours. 3) sleep onset latency (SOL) in mins. 4) wake after sleep onset (WASO) in mins. 5) sleep efficiency (SE), which is calculated by total sleep time divided by total time in bed, %.
Measured: 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.
Parent: Change of parental actigraphy-based measures
The parental sleep-wake pattern will be objectively measured by 7-day wrist actigraphy. Sleep parameter estimated by actigraphy will include time in bed, total sleep time, sleep onset latency (SOL), wake after sleep onset (WASO), and sleep efficiency.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Jan 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Responsible party
- Principal investigator, Dr. Shirley Xin Li, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398183
- Sponsor's protocol ID
- EA240518
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Digitally Delivered Parent-based Behavioural Sleep Intervention in Children With Autism Spectrum Disorder (ASD) - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07398183
- Acronym / sponsor ID
- EA240518
- Conditions
- Insomnia, Autism Spectrum Disorder (ASD)
- Keywords
- insomnia, Autism spectrum disorder, ASD, behavioral sleep intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| App-based CBT-I with personalised telephone support | Experimental | Behavioral: App-based CBT-I with personalised telephone supportApp-based cognitive behavioural therapy for insomnia with personalised telephone support |
| App-based CBT-I without personalised support | Experimental | Behavioral: App-based CBT-I without personalised telephone supportApp-based cognitive behavioural therapy for insomnia 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- (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;
Key exclusion criteria (3 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based CBT-I with personalised telephone supportAlso: App-based intervention with personalised supportParticipants 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. | Behavioural | App-based CBT-I with personalised telephone support |
| App-based CBT-I without personalised telephone supportAlso: App-based intervention without personalised supportParticipants 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. | Behavioural | App-based CBT-I without personalised support |
Primary outcome
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.
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.
15 secondary outcomes
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.
Parent: Change of parental quailty 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.
Parent: Change of parental 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.
Parent: Change of parental 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 participants in the treatment groups.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based CBT-I with personalised telephone support and App-based CBT-I without personalised telephone support in people with Insomnia and Autism Spectrum Disorder (ASD), run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shirley X Li (852-39177035, shirley.li@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.