Back to resultsA Brief Parent-based Sleep Intervention for ADHD Children
Primary Purpose
ADHD, Insomnia
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Sleep hygiene practices and behavioural intervention
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring sleep, ADHD, behavioural intervention, insomnia
Eligibility Criteria
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.
Sites / Locations
- Child and Adolescent Psychiatric Service Clinic, New Territories East Cluster (NTEC), Hospital AuthorityRecruiting
- Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong KongRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Waiting-list control
Arm Description
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.
Children in the waiting-list control group will receive usual clinical care.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Child: Change of daytime sleepiness
Pediatric Daytime Sleepiness Scale (PDSS) - parent report
Child: Change of other sleep measures
Daily sleep diary and actigraphic assessment for consecutive seven days
Child: Change of ADHD symptoms
Strengths and Weaknesses of ADHD Symptoms (SWAN) - parent report
Child: Change of child's behaviour & other clinical symptoms
Strengths and Difficulties Questionnaire - parent report; Child Behavior Checklist (CBCL) - parent report
Child: Change of quality of life
Pediatric Quality of Life Inventory 4.0 - parent proxy report (PedsQL) - parent report
Child: Change of cognitive performance (sustained attention)
Continuous Performance Test (CPT)
Child: Change of cognitive performance (auditory attention span)
Digit Span
Child: Change of cognitive performance (working memory)
N-back
Child: Change of cognitive performance (cognitive processing)
Letter-digit substitution task
Child: Change of cognitive performance (cognitive flexibility)
Bergs Card Sorting Test (BCST)
Child: Change of cognitive performance (planning skills)
Tower of London (TOL)
Change of parental self-reported sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Change of parental insomnia symptoms
Insomnia Severity Index (ISI)
Change of parental daytime sleepiness
Epworth Sleepiness Questionnaire (ESS)
Change of parental sleep parameters as measured by actigraphy
Actigraphic sleep parameters
Change of parental sleep hygiene practice
Sleep Hygiene Index (SHI)
Change of parental stress
Parental Stress Index - Short Form (PSI-SF)
Change of parental mood symptoms
Depression Anxiety Stress Scales - 21 item (DASS-21)
Change of parental daytime fatigue
Multidimensional Fatigue Inventory (MFI)
Parent's satisfaction to the treatment
Treatment satisfaction rating scale
Full Information
NCT ID
NCT03263156
First Posted
August 23, 2017
Last Updated
April 24, 2021
Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03263156
Brief Title
A Brief Parent-based Sleep Intervention for ADHD Children
Official Title
Effects of a Brief Parent-based Sleep Intervention for Children With Attention Deficit Hyperactivity Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
Collaborators
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Insomnia
Keywords
sleep, ADHD, behavioural intervention, insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting-list control
Arm Type
No Intervention
Arm Description
Children in the waiting-list control group will receive usual clinical care.
Intervention Type
Behavioral
Intervention Name(s)
Sleep hygiene practices and behavioural intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child: Change of child's sleep
Description
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)
Time Frame
Baseline, 1-week and 3-month posttreatment
Secondary Outcome Measure Information:
Title
Child: Change of daytime sleepiness
Description
Pediatric Daytime Sleepiness Scale (PDSS) - parent report
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Child: Change of other sleep measures
Description
Daily sleep diary and actigraphic assessment for consecutive seven days
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Child: Change of ADHD symptoms
Description
Strengths and Weaknesses of ADHD Symptoms (SWAN) - parent report
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Child: Change of child's behaviour & other clinical symptoms
Description
Strengths and Difficulties Questionnaire - parent report; Child Behavior Checklist (CBCL) - parent report
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Child: Change of quality of life
Description
Pediatric Quality of Life Inventory 4.0 - parent proxy report (PedsQL) - parent report
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Child: Change of cognitive performance (sustained attention)
Description
Continuous Performance Test (CPT)
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Child: Change of cognitive performance (auditory attention span)
Description
Digit Span
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Child: Change of cognitive performance (working memory)
Description
N-back
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Child: Change of cognitive performance (cognitive processing)
Description
Letter-digit substitution task
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Child: Change of cognitive performance (cognitive flexibility)
Description
Bergs Card Sorting Test (BCST)
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Child: Change of cognitive performance (planning skills)
Description
Tower of London (TOL)
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Change of parental self-reported sleep quality
Description
Pittsburgh Sleep Quality Index (PSQI)
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Change of parental insomnia symptoms
Description
Insomnia Severity Index (ISI)
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Change of parental daytime sleepiness
Description
Epworth Sleepiness Questionnaire (ESS)
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Change of parental sleep parameters as measured by actigraphy
Description
Actigraphic sleep parameters
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Change of parental sleep hygiene practice
Description
Sleep Hygiene Index (SHI)
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Change of parental stress
Description
Parental Stress Index - Short Form (PSI-SF)
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Change of parental mood symptoms
Description
Depression Anxiety Stress Scales - 21 item (DASS-21)
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Change of parental daytime fatigue
Description
Multidimensional Fatigue Inventory (MFI)
Time Frame
Baseline, 1-week and 3-month posttreatment
Title
Parent's satisfaction to the treatment
Description
Treatment satisfaction rating scale
Time Frame
Baseline, 1-week and 3-month posttreatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shirley Xin Li, PhD,DClinPsy
Phone
852-39177035
Email
shirley.li@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shirley Xin Li, PhD,DClinPsy
Organizational Affiliation
Department of Psychology, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Child and Adolescent Psychiatric Service Clinic, New Territories East Cluster (NTEC), Hospital Authority
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly YC Lai, MRCPsych,FHKAM(Psych)
Phone
(852)26076025
Email
kellylai@cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Ka Sin Caroline Shea, FHKCPsy
Phone
(852)26076724
Email
carolinesks@gmail.com
Facility Name
Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirley Xin Li, PhD,DClinPsy
Phone
852-39177035
Email
shirley.li@hku.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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A Brief Parent-based Sleep Intervention for ADHD Children
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