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Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial

Primary Purpose

Attention Deficit Hyperactivity Disorders, Neurodevelopmental Disorders, Attention Deficit Disorder With Hyperactivity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Good Night Project
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorders focused on measuring Behavioural interventions, Sleep difficulties, Children, Attention Deficit Hyperactivity Disorder, Randomised controlled trial, Saudi Arabia, Behavioural Insomnia

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participants will be primary caregivers (women) of children aged 5-12 years who have been diagnosed with ADHD by a psychiatrist, using the criteria taken from Diagnostic and Statistical Manual of Mental Disorders-5 in Saudi Arabia.
  • Children with comorbidities will be also included.
  • Sleep difficulties are defined as a total score of over 41 in the Children's Sleep Habits Questionnaire (CSHQ).

Exclusion Criteria:

Children will be excluded from the study if they meet any of the following criteria:

  • They receive non-pharmacological interventions for their sleep difficulties.
  • They have been previously diagnosed as having an intellectual disability (IQ < 70).
  • They have obstructive sleep apnoea, according to the three items in the CSHQ.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention group

    Control group - usual care

    Arm Description

    Participants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks

    Participants in the control group will receive usual care. They will also attend their usual appointments with the psychiatrists. They will not receive any intervention.

    Outcomes

    Primary Outcome Measures

    The Children's Sleep Habits Questionnaire CSHQ
    This is used widely to assess sleep, pre and post intervention, and focuses on measurement of the following subscales: Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnias, sleep-disordered breathing and daytime sleepiness. Higher scores indicate significant sleep difficulties.
    Conners' Parent Rating Scale-48 (CPRS-48)
    This scale consists of 48 items that focus on five subscales: conduct problems, learning disabilities, psychosomatic disorders, impulsivity and hyperactivity and anxiety. It focuses on children aged 3-17 years.

    Secondary Outcome Measures

    The Sleep Disorders Scale for primary caregivers
    This scale consists of 36 items that focus on sleep difficulties in adults, and is divided according to the following subscales: insomnia, hypersomnia, circadian rhythm sleep disorders, sleep terrors and sleepwalking.
    The Depression Anxiety Stress Scales DASS
    This is designed to measure negative emotions in adults, according to three subscales: depression, anxiety and stress.
    Conners' Teachers Rating Scale-28 (CTRS-28)
    This scale consists of 28 items that focus on three subscales: Conduct problems, Hyperactivity, Inattentive and Passive. It focuses on children aged 3-17 years.

    Full Information

    First Posted
    August 9, 2016
    Last Updated
    January 31, 2017
    Sponsor
    University of Leeds
    Collaborators
    Shaqra University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02871674
    Brief Title
    Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial
    Official Title
    Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    August 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Leeds
    Collaborators
    Shaqra University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The study aims to implement and evaluate an RCT of behavioural sleep interventions for children aged 5-12 years with ADHD, and their primary caregivers, (women) in Saudi Arabia to address the following questions: To what extent can a behavioural intervention improve sleep difficulties and increase sleep duration in children with ADHD? To what extent do intervention-induced changes in sleep for children or primary caregivers (women) account for any changes in ADHD symptoms?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Attention Deficit Hyperactivity Disorders, Neurodevelopmental Disorders, Attention Deficit Disorder With Hyperactivity
    Keywords
    Behavioural interventions, Sleep difficulties, Children, Attention Deficit Hyperactivity Disorder, Randomised controlled trial, Saudi Arabia, Behavioural Insomnia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention group
    Arm Type
    Experimental
    Arm Description
    Participants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks
    Arm Title
    Control group - usual care
    Arm Type
    No Intervention
    Arm Description
    Participants in the control group will receive usual care. They will also attend their usual appointments with the psychiatrists. They will not receive any intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Good Night Project
    Intervention Description
    The behavioural interventions have been designed on the basis of three sources. Firstly, a systematic review conducted by the research team that examined the best evidence in the field in different countries. Secondly, a Delphi study, which aimed to identify behavioural interventions that can be used to manage sleep difficulties in Saudi Arabia in accordance with professionals' views and primary caregivers' needs, and which was also conducted by the research team. Thirdly, evidence-based practice resources that help in understanding and managing sleep difficulties will be translated into Arabic.
    Primary Outcome Measure Information:
    Title
    The Children's Sleep Habits Questionnaire CSHQ
    Description
    This is used widely to assess sleep, pre and post intervention, and focuses on measurement of the following subscales: Bedtime resistance, sleep onset delay, sleep duration, sleep anxiety, night waking, parasomnias, sleep-disordered breathing and daytime sleepiness. Higher scores indicate significant sleep difficulties.
    Time Frame
    2 months
    Title
    Conners' Parent Rating Scale-48 (CPRS-48)
    Description
    This scale consists of 48 items that focus on five subscales: conduct problems, learning disabilities, psychosomatic disorders, impulsivity and hyperactivity and anxiety. It focuses on children aged 3-17 years.
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    The Sleep Disorders Scale for primary caregivers
    Description
    This scale consists of 36 items that focus on sleep difficulties in adults, and is divided according to the following subscales: insomnia, hypersomnia, circadian rhythm sleep disorders, sleep terrors and sleepwalking.
    Time Frame
    2 months
    Title
    The Depression Anxiety Stress Scales DASS
    Description
    This is designed to measure negative emotions in adults, according to three subscales: depression, anxiety and stress.
    Time Frame
    2 months
    Title
    Conners' Teachers Rating Scale-28 (CTRS-28)
    Description
    This scale consists of 28 items that focus on three subscales: Conduct problems, Hyperactivity, Inattentive and Passive. It focuses on children aged 3-17 years.
    Time Frame
    1 month
    Other Pre-specified Outcome Measures:
    Title
    Activity monitor (ActiGraph)
    Description
    This outcome records the physical activity in order to provide sleep duration in seven days at baseline and seven days after a month of randomization to measure change. It will be used as an objective measure with some participants.
    Time Frame
    1 month
    Title
    Activity monitor diary
    Description
    This outcome records sleep/wake time and related information in seven days at baseline and seven days after a month of randomization to measure change. It will be used with some participants to support Activity monitor (ActiGraph) measure.
    Time Frame
    1 month
    Title
    Demographic form
    Description
    The form will be used to collect demographic information for both primary caregivers and their children
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The participants will be primary caregivers (women) of children aged 5-12 years who have been diagnosed with ADHD by a psychiatrist, using the criteria taken from Diagnostic and Statistical Manual of Mental Disorders-5 in Saudi Arabia. Children with comorbidities will be also included. Sleep difficulties are defined as a total score of over 41 in the Children's Sleep Habits Questionnaire (CSHQ). Exclusion Criteria: Children will be excluded from the study if they meet any of the following criteria: They receive non-pharmacological interventions for their sleep difficulties. They have been previously diagnosed as having an intellectual disability (IQ < 70). They have obstructive sleep apnoea, according to the three items in the CSHQ.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hetaf A Alammar, PhD student
    Organizational Affiliation
    University of Leeds
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial

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