Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Shaqra University, Saudi Arabia
Information provided by (Responsible Party):
Hetaf Alammar, University of Leeds

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:

  1. To what extent can a behavioural intervention improve sleep difficulties and increase sleep duration in children with ADHD?
  2. 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. Demographic form [ Time Frame: Baseline ]
    The form will be used to collect demographic information for both primary caregivers and their children



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Leeds
Shaqra University, Saudi Arabia
Investigators
Layout table for investigator information
Principal Investigator: Hetaf A Alammar, PhD student University of Leeds
Layout table for additonal information
Responsible Party: Hetaf Alammar, PhD student, University of Leeds
ClinicalTrials.gov Identifier: NCT02871674    
Other Study ID Numbers: 0000
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Keywords provided by Hetaf Alammar, University of Leeds:
Behavioural interventions
Sleep difficulties
Children
Attention Deficit Hyperactivity Disorder
Randomised controlled trial
Saudi Arabia
Behavioural Insomnia
Additional relevant MeSH terms:
Layout table for MeSH terms
Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Neurodevelopmental Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms