ADHDNCT03263156
A Brief Parent-based Sleep Intervention for ADHD Children
A study testing Sleep hygiene practices and behavioural intervention in people with ADHD 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 ADHD, with a prevalence rate as high as 73%, and often pose significant challenges and stress to the families. Sleep problems in ADHD children are strongly associated with the exacerbation of daytime symptoms, impaired physical health, and poor parental mental health. Read more about this study
- Who is it for?
- Ages 6 to 12 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
- 60 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Apr 2017to 31 Dec 2021
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6-12 years old;
- With a clinical diagnosis of ADHD (any subtype), as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
- With parent-reported insomnia (difficulty initiating sleep and/or maintaining sleep).
Who cannot join
- Children with a serious medical condition (e.g. severe cerebral palsy) or intellectual disability (IQ<70);
- Children with a neurological and/or medical condition that may lead to disordered sleep;
- Suspected clinical sleep disorders (e.g. obstructive sleep apnea, OSA) that may potentially contribute to a disruption in sleep continuity and quality, as assessed by the Children's Sleep Habits Questionnaire (CSHQ). If the child is suspected of a clinical sleep disorder, he/she will be referred to appropriate services;
- Children who are already receiving specialised help (behavioural intervention) for their sleep from a psychologist or at a specialized sleep clinic.
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites, 2 recruiting
- Recruiting
Child and Adolescent Psychiatric Service Clinic, New Territories East Cluster (NTEC), Hospital Authority
Hong Kong
Kelly YC Lai, MRCPsych,FHKAM(Psych), (852)26076025, kellylai@cuhk.edu.hk
Ka Sin Caroline Shea, FHKCPsy, (852)26076724, carolinesks@gmail.com
- Recruiting
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Hong Kong
Shirley Xin Li, PhD,DClinPsy, 852-39177035, shirley.li@hku.hk
About this study
Official title: Effects of a Brief Parent-based Sleep Intervention for Children With Attention Deficit Hyperactivity Disorder
Sleep problems are very common in children with ADHD, with a prevalence rate as high as 73%, and often pose significant challenges and stress to the families. Sleep problems in ADHD children are strongly associated with the exacerbation of daytime symptoms, impaired physical health, and poor parental mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ADHD (aged 6-12). Eligible participants will be randomised to either intervention (two face-to-face consultation sessions and one follow-up phone call) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), one-week after the intervention (post-treatment), and 3 months after the intervention.
- Being tested
- Sleep hygiene practices and behavioural intervention
- Keywords
- sleep, ADHD, behavioural intervention, insomnia
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, 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 for the next two weeks. The second 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. A follow-up phone call will be made two weeks later to 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 two face-to-face consultation sessions and one follow-up phone call 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), and sleep problems rated by parent (none, mild, moderate, severe)
Measured: Baseline, 1-week and 3-month posttreatment
Secondary outcomes (20)
Child: Change of daytime sleepiness
Pediatric Daytime Sleepiness Scale (PDSS) - parent report
Measured: Baseline, 1-week and 3-month posttreatment
Child: Change of other sleep measures
Daily sleep diary and actigraphic assessment for consecutive seven days
Measured: Baseline, 1-week and 3-month posttreatment
Child: Change of ADHD symptoms
Strengths and Weaknesses of ADHD Symptoms (SWAN) - parent report
Measured: Baseline, 1-week and 3-month posttreatment
Child: Change of child's behaviour & other clinical symptoms
Strengths and Difficulties Questionnaire - parent report; Child Behavior Checklist (CBCL) - parent report
Measured: Baseline, 1-week and 3-month posttreatment
Child: Change of quality of life
Pediatric Quality of Life Inventory 4.0 - parent proxy report (PedsQL) - parent report
Measured: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (sustained attention)
Continuous Performance Test (CPT)
Measured: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (auditory attention span)
Digit Span
Measured: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (working memory)
N-back
Measured: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (cognitive processing)
Letter-digit substitution task
Measured: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (cognitive flexibility)
Bergs Card Sorting Test (BCST)
Measured: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (planning skills)
Tower of London (TOL)
Measured: Baseline, 1-week and 3-month posttreatment
Change of parental self-reported sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: Baseline, 1-week and 3-month posttreatment
Change of parental insomnia symptoms
Insomnia Severity Index (ISI)
Measured: Baseline, 1-week and 3-month posttreatment
Change of parental daytime sleepiness
Epworth Sleepiness Questionnaire (ESS)
Measured: Baseline, 1-week and 3-month posttreatment
Change of parental sleep parameters as measured by actigraphy
Actigraphic sleep parameters
Measured: Baseline, 1-week and 3-month posttreatment
Change of parental sleep hygiene practice
Sleep Hygiene Index (SHI)
Measured: Baseline, 1-week and 3-month posttreatment
Change of parental stress
Parental Stress Index - Short Form (PSI-SF)
Measured: Baseline, 1-week and 3-month posttreatment
Change of parental mood symptoms
Depression Anxiety Stress Scales - 21 item (DASS-21)
Measured: Baseline, 1-week and 3-month posttreatment
Change of parental daytime fatigue
Multidimensional Fatigue Inventory (MFI)
Measured: Baseline, 1-week and 3-month posttreatment
Parent's satisfaction to the treatment
Treatment satisfaction rating scale
Measured: Baseline, 1-week and 3-month posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start1 Apr 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- 60 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
- Investigators
- Shirley Xin Li, PhD,DClinPsy, Principal investigator, Department of Psychology, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263156
- Sponsor's protocol ID
- 30160604
- Status last verified
- Apr 2021
- First submitted
- 23 Aug 2017
- Last updated
- 27 Apr 2021
- 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 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Brief Parent-based Sleep Intervention for Children With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03263156
- Acronym / sponsor ID
- 30160604
- Keywords
- sleep, ADHD, behavioural intervention, insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 28 Aug 2017 (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 ADHD, with a prevalence rate as high as 73%, and often pose significant challenges and stress to the families. Sleep problems in ADHD children are strongly associated with the exacerbation of daytime symptoms, impaired physical health, and poor parental mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ADHD (aged 6-12). Eligible participants will be randomised to either intervention (two face-to-face consultation sessions and one follow-up phone call) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), one-week after the intervention (post-treatment), and 3 months after the intervention.
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 two face-to-face consultation sessions and one follow-up phone call 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
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 6-12 years old;
- With a clinical diagnosis of ADHD (any subtype), as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
- With parent-reported insomnia (difficulty initiating sleep and/or maintaining sleep).
Key exclusion criteria (4 listed)
- Children with a serious medical condition (e.g. severe cerebral palsy) or intellectual disability (IQ<70);
- Children with a neurological and/or medical condition that may lead to disordered sleep;
- Suspected clinical sleep disorders (e.g. obstructive sleep apnea, OSA) that may potentially contribute to a disruption in sleep continuity and quality, as assessed by the Children's Sleep Habits Questionnaire (CSHQ). If the child is suspected of a clinical sleep disorder, he/she will be referred to appropriate services;
- Children who are already receiving specialised help (behavioural intervention) for their sleep from a psychologist or at a specialized sleep clinic.
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 for the next two weeks. The second 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. A follow-up phone call will be made two weeks later to 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, 1-week and 3-month posttreatment
Change of the child's sleep measured by the Children's Sleep Habits Questionnaire (CSHQ), and sleep problems rated by parent (none, mild, moderate, severe)
20 secondary outcomes
Child: Change of daytime sleepiness
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of other sleep measures
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of ADHD symptoms
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of child's behaviour & other clinical symptoms
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of quality of life
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (sustained attention)
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (auditory attention span)
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (working memory)
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (cognitive processing)
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (cognitive flexibility)
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (planning skills)
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental self-reported sleep quality
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental insomnia symptoms
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental daytime sleepiness
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental sleep parameters as measured by actigraphy
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental sleep hygiene practice
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental stress
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental mood symptoms
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental daytime fatigue
Time frame: Baseline, 1-week and 3-month posttreatment
Parent's satisfaction to the treatment
Time frame: Baseline, 1-week and 3-month posttreatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- 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
Department of Psychology, 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 ADHD 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Apr 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirley Xin Li, PhD,DClinPsy (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 (time frame: Baseline, 1-week and 3-month posttreatment). 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 27 Apr 2021.