ASDNCT05010824
A Brief Parent-based Sleep Intervention for Children With Autism Spectrum Disorder
A study testing Sleep hygiene practices and behavioural intervention in people with ASD and Insomnia, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- What is being tested?
- Sleep hygiene practices and behavioural intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesHong Kong
- Study dates
- 5 Aug 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Department of Clinical Psychology, The Duchess of Kent Children's Hospital at Sandy Bay, HKWC, Hospital Authority
Hong Kong
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
About this study
Official title: Effects of Parent-based Educational Programme for Sleep Problems in Children With Autism Spectrum Disorder (ASD): A Randomized Controlled Trial
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).
- Being tested
- Sleep hygiene practices and behavioural intervention
- Keywords
- Sleep, ASD, Insomnia, Behavioral Intervention
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep hygiene practices and behavioural interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep hygiene practices and behavioural intervention |
| Waiting-list control | No intervention | Children in the waiting-list control group will receive usual clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, immediately after the treatment
Secondary outcomes (9)
Parent: Change of parental self-reported sleep quality
Pittsburgh Sleep Quality Index (PSQI), a validated 19-item measure used to assess sleep habits, quality, and quantity, producing a total score and seven sub-scores in sleep quality, sleep onset latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The global score can range from 0 to 21. Higher scores suggest poorer sleep quality.
Measured: Baseline, immediately after the treatment
Parent: Change of parental insomnia symptoms
Insomnia Severity Index (ISI). Total score ranges from 0-28 and higher scores indicate greater insomnia severity.
Measured: Baseline, immediately after the treatment
Child: Change of child's behaviour & other clinical symptoms
Strengths and Difficulties Questionnaire - parent report, which is a 25-item screening measure for emotional and behavioral problems in children. It consists of five subscales. Each of the subscales consists of five items, and scale scores range from 0-10. A higher score is indicative of more problems for all subscales, except for the prosocial scale, where higher scores correspond to fewer difficulties in prosocial behaviour.
Measured: Baseline, immediately after the treatment
Child: Change of child's executive functions reported by parents
Behavioral Rating Inventory of Executive Function - Preschool Version (BRIEF-P). It consists of 63 items that measure various behavioral manifestations of EF based on parent or teacher ratings, within the context of the child's everyday environment.
Measured: Baseline, immediately after the treatment
Parent: Change of parental mood symptoms
Depression Anxiety Stress Scales - 21 item (DASS-21) consists of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items. Higher scores suggest more depression, anxiety and stress, respectively.
Measured: Baseline, immediately after the treatment
Parent: Change of parental stress
Chinese version of Parental Stress Scale (PSS). It contains 17 items representing pleasure or positive themes of parenthood (emotional benefits, self-enrichment, personal development) and negative components (demands on resources, opportunity costs and restrictions). Higher scores on the scale indicate greater stress.
Measured: Baseline, immediately after the treatment
Parent: Change of parental sense of competence and satisfactory in parenting
Parental Sense of Competence Scale (PSOC), which is a scale designed to measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 16-item Likert-scale questionnaire (on a 6-point scale ranging from strongly agree [1] to strongly disagree [6]), with nine questions under Satisfaction and seven under Efficacy.
Measured: Baseline, immediately after the treatment
Parent: Parent's satisfaction to the treatment
Treatment satisfaction rating scale, a parent-report measure specifically designed for the study. Lower scores suggest higher parental satisfaction.
Measured: Baseline, immediately after the treatment
Parent: Parent's overall health status
Short Form 12-item Health Survey (SF-12v2), a validated measure of health-related quality of life (HRQOL). It consists of 12 items that cover 8 subscales, namely physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). The eight subscale scores can be aggregated into a physical component summary (PCS) score and a mental component summary (MCS) score. Each of the eight SF-12v2 subscale has a scoring range from 0 to 100; a higher score indicates better HRQOL.
Measured: Baseline, immediately after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start5 Aug 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASDStudies 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shirley Xin Li, The University of Hong Kong
- Investigators
- Shirley Xin Li, PhD,DClinPsy, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05010824
- Sponsor's protocol ID
- UW20-204
- Status last verified
- Sep 2023
- First submitted
- 5 Aug 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parent-based Educational Programme for Sleep Problems in Children With Autism Spectrum Disorder (ASD): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05010824
- Acronym / sponsor ID
- UW20-204
- Keywords
- Sleep, ASD, Insomnia, Behavioral Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 18 Aug 2021 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Sleep hygiene practices and behavioural interventionThe 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. |
| Waiting-list control | No intervention | –Children in the waiting-list control group will receive usual clinical care. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
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 |
|---|---|---|
| Sleep hygiene practices and behavioural interventionThe 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. | Behavioural | Intervention group |
Primary outcome
Child: Change of child's sleep
Time frame: Baseline, immediately after the treatment
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.
Child: change of insomnia symptoms (bedtime resistance)
Time frame: Baseline, immediately after the treatment
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)
Child: change of insomnia symptoms (sleep onset delay)
Time frame: Baseline, immediately after the treatment
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)
Child: change of insomnia symptoms (night waking)
Time frame: Baseline, immediately after the treatment
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)
9 secondary outcomes
Parent: Change of parental self-reported sleep quality
Time frame: Baseline, immediately after the treatment
Parent: Change of parental insomnia symptoms
Time frame: Baseline, immediately after the treatment
Child: Change of child's behaviour & other clinical symptoms
Time frame: Baseline, immediately after the treatment
Child: Change of child's executive functions reported by parents
Time frame: Baseline, immediately after the treatment
Parent: Change of parental mood symptoms
Time frame: Baseline, immediately after the treatment
Parent: Change of parental stress
Time frame: Baseline, immediately after the treatment
Parent: Change of parental sense of competence and satisfactory in parenting
Time frame: Baseline, immediately after the treatment
Parent: Parent's satisfaction to the treatment
Time frame: Baseline, immediately after the treatment
Parent: Parent's overall health status
Time frame: Baseline, immediately after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Shirley Xin Li, PhD,DClinPsy principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep hygiene practices and behavioural intervention in people with ASD and Insomnia, run by The University of Hong Kong at 2 sites 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child: Change of child's sleep (time frame: Baseline, immediately after the treatment). The study lists 4 primary outcomes in all. 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 21 Sep 2023.