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

NCT02871674 | Unknown

• 1 other identifier: 0000
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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. 1.To what extent can a behavioural intervention improve sleep difficulties and increase sleep duration in children with ADHD?
2. 2.To what extent do intervention-induced changes in sleep for children or primary caregivers (women) account for any changes in ADHD symptoms?

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  2 months

• 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.

  2 months

Secondary Outcomes (3)

• The Sleep Disorders Scale for primary caregivers

  2 months

• The Depression Anxiety Stress Scales DASS

  2 months

• Conners' Teachers Rating Scale-28 (CTRS-28)

  1 month

Other Outcomes (3)

• Activity monitor (ActiGraph)

  1 month

• Activity monitor diary

  1 month

• Demographic form

  Baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Good Night Project

Control group - usual care

NO INTERVENTION

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.

Interventions

Good Night Project BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leeds: lead
• Shaqra University: collaborator

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Mental Disorders

Study Officials

• Hetaf A Alammar, PhD student

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 18, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 1, 2017

Record last verified: 2017-01