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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Sleep hygiene practices and behavioural intervention
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chinese University of Hong Kong

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 27, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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