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

Conditions

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

      • Hong Kong, Hong Kong
        • Recruiting
        • Child and Adolescent Psychiatric Service Clinic, New Territories East Cluster (NTEC), Hospital Authority
        • Contact:
        • Contact:
      • Hong Kong, Hong Kong
        • Recruiting
        • Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong

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
Child: Change of cognitive performance (sustained attention)
Time Frame: Baseline, 1-week and 3-month posttreatment
Continuous Performance Test (CPT)
Baseline, 1-week and 3-month posttreatment
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
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
Pittsburgh Sleep Quality Index (PSQI)
Baseline, 1-week and 3-month posttreatment
Change of parental insomnia symptoms
Time Frame: Baseline, 1-week and 3-month posttreatment
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
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
Change of parental stress
Time Frame: Baseline, 1-week and 3-month posttreatment
Parental Stress Index - Short Form (PSI-SF)
Baseline, 1-week and 3-month posttreatment
Change of parental mood symptoms
Time Frame: Baseline, 1-week and 3-month posttreatment
Depression Anxiety Stress Scales - 21 item (DASS-21)
Baseline, 1-week and 3-month posttreatment
Change of parental daytime fatigue
Time Frame: Baseline, 1-week and 3-month posttreatment
Multidimensional Fatigue Inventory (MFI)
Baseline, 1-week and 3-month posttreatment
Parent's satisfaction to the treatment
Time Frame: Baseline, 1-week and 3-month posttreatment
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.

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

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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