Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial
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|ClinicalTrials.gov Identifier: NCT02871674|
Recruitment Status : Unknown
Verified January 2017 by Hetaf Alammar, University of Leeds.
Recruitment status was: Enrolling by invitation
First Posted : August 18, 2016
Last Update Posted : February 1, 2017
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?
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorders Neurodevelopmental Disorders Attention Deficit Disorder With Hyperactivity||Behavioral: Good Night Project||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||August 2017|
Experimental: Intervention group
Participants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks
Behavioral: Good Night Project
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.
No Intervention: Control group - usual care
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.
- The Children's Sleep Habits Questionnaire CSHQ [ Time Frame: 2 months ]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) [ Time Frame: 2 months ]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.
- The Sleep Disorders Scale for primary caregivers [ Time Frame: 2 months ]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 [ Time Frame: 2 months ]This is designed to measure negative emotions in adults, according to three subscales: depression, anxiety and stress.
- Conners' Teachers Rating Scale-28 (CTRS-28) [ Time Frame: 1 month ]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.
- Activity monitor (ActiGraph) [ Time Frame: 1 month ]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.
- Activity monitor diary [ Time Frame: 1 month ]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.
- Demographic form [ Time Frame: Baseline ]The form will be used to collect demographic information for both primary caregivers and their children
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02871674
|Principal Investigator:||Hetaf A Alammar, PhD student||University of Leeds|