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

Tracking Information
First Submitted Date  ICMJE August 9, 2016
First Posted Date  ICMJE August 18, 2016
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE October 2016
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 15, 2016)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial
Official Title  ICMJE Good Night Project: Behavioural Sleep Interventions for Children With ADHD: A Randomised Controlled Trial
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?
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Attention Deficit Hyperactivity Disorders
  • Neurodevelopmental Disorders
  • Attention Deficit Disorder With Hyperactivity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention group
    Participants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks
    Intervention: Behavioral: Good Night Project
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 15, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02871674
Other Study ID Numbers  ICMJE 0000
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hetaf Alammar, University of Leeds
Study Sponsor  ICMJE University of Leeds
Collaborators  ICMJE Shaqra University, Saudi Arabia
Investigators  ICMJE
Principal Investigator: Hetaf A Alammar, PhD student University of Leeds
PRS Account University of Leeds
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP