- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03263156
A Brief Parent-based Sleep Intervention for ADHD Children
April 24, 2021 updated by: Dr. Shirley Xin Li, The University of Hong Kong
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Hong Kong, Hong Kong
- Recruiting
- Child and Adolescent Psychiatric Service Clinic, New Territories East Cluster (NTEC), Hospital Authority
-
Contact:
- Kelly YC Lai, MRCPsych,FHKAM(Psych)
- Phone Number: (852)26076025
- Email: kellylai@cuhk.edu.hk
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Contact:
- Ka Sin Caroline Shea, FHKCPsy
- Phone Number: (852)26076724
- Email: carolinesks@gmail.com
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Hong Kong, Hong Kong
- Recruiting
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
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.
|
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.
|
No Intervention: Waiting-list control
Children in the waiting-list control group will receive usual clinical care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Baseline, 1-week and 3-month posttreatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Child: Change of daytime sleepiness
Time Frame: Baseline, 1-week and 3-month posttreatment
|
Pediatric Daytime Sleepiness Scale (PDSS) - parent report
|
Baseline, 1-week and 3-month posttreatment
|
Child: Change of other sleep measures
Time Frame: Baseline, 1-week and 3-month posttreatment
|
Daily sleep diary and actigraphic assessment for consecutive seven days
|
Baseline, 1-week and 3-month posttreatment
|
Child: Change of ADHD symptoms
Time Frame: Baseline, 1-week and 3-month posttreatment
|
Strengths and Weaknesses of ADHD Symptoms (SWAN) - parent report
|
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
|
Strengths and Difficulties Questionnaire - parent report; Child Behavior Checklist (CBCL) - parent report
|
Baseline, 1-week and 3-month posttreatment
|
Child: Change of quality of life
Time Frame: Baseline, 1-week and 3-month posttreatment
|
Pediatric Quality of Life Inventory 4.0 - parent proxy report (PedsQL) - parent report
|
Baseline, 1-week and 3-month posttreatment
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Child: Change of cognitive performance (sustained attention)
Time Frame: Baseline, 1-week and 3-month posttreatment
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Continuous Performance Test (CPT)
|
Baseline, 1-week and 3-month posttreatment
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Child: Change of cognitive performance (auditory attention span)
Time Frame: Baseline, 1-week and 3-month posttreatment
|
Digit Span
|
Baseline, 1-week and 3-month posttreatment
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Child: Change of cognitive performance (working memory)
Time Frame: Baseline, 1-week and 3-month posttreatment
|
N-back
|
Baseline, 1-week and 3-month posttreatment
|
Child: Change of cognitive performance (cognitive processing)
Time Frame: Baseline, 1-week and 3-month posttreatment
|
Letter-digit substitution task
|
Baseline, 1-week and 3-month posttreatment
|
Child: Change of cognitive performance (cognitive flexibility)
Time Frame: Baseline, 1-week and 3-month posttreatment
|
Bergs Card Sorting Test (BCST)
|
Baseline, 1-week and 3-month posttreatment
|
Child: Change of cognitive performance (planning skills)
Time Frame: Baseline, 1-week and 3-month posttreatment
|
Tower of London (TOL)
|
Baseline, 1-week and 3-month posttreatment
|
Change of parental self-reported sleep quality
Time Frame: Baseline, 1-week and 3-month posttreatment
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Pittsburgh Sleep Quality Index (PSQI)
|
Baseline, 1-week and 3-month posttreatment
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Change of parental insomnia symptoms
Time Frame: Baseline, 1-week and 3-month posttreatment
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Insomnia Severity Index (ISI)
|
Baseline, 1-week and 3-month posttreatment
|
Change of parental daytime sleepiness
Time Frame: Baseline, 1-week and 3-month posttreatment
|
Epworth Sleepiness Questionnaire (ESS)
|
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
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Actigraphic sleep parameters
|
Baseline, 1-week and 3-month posttreatment
|
Change of parental sleep hygiene practice
Time Frame: Baseline, 1-week and 3-month posttreatment
|
Sleep Hygiene Index (SHI)
|
Baseline, 1-week and 3-month posttreatment
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Change of parental stress
Time Frame: Baseline, 1-week and 3-month posttreatment
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Parental Stress Index - Short Form (PSI-SF)
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Baseline, 1-week and 3-month posttreatment
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Change of parental mood symptoms
Time Frame: Baseline, 1-week and 3-month posttreatment
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Depression Anxiety Stress Scales - 21 item (DASS-21)
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Baseline, 1-week and 3-month posttreatment
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Change of parental daytime fatigue
Time Frame: Baseline, 1-week and 3-month posttreatment
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Multidimensional Fatigue Inventory (MFI)
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Baseline, 1-week and 3-month posttreatment
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Parent's satisfaction to the treatment
Time Frame: Baseline, 1-week and 3-month posttreatment
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Treatment satisfaction rating scale
|
Baseline, 1-week and 3-month posttreatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shirley Xin Li, PhD,DClinPsy, Department of Psychology, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2017
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
August 23, 2017
First Submitted That Met QC Criteria
August 25, 2017
First Posted (Actual)
August 28, 2017
Study Record Updates
Last Update Posted (Actual)
April 27, 2021
Last Update Submitted That Met QC Criteria
April 24, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30160604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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