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

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?

Study Overview

• Status: Unknown
• Conditions: Neurodevelopmental Disorders; Attention Deficit Disorder With Hyperactivity; Attention Deficit Hyperactivity Disorders
• Intervention / Treatment: Behavioral: Good Night Project

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 months
The Depression Anxiety Stress Scales DASS	This is designed to measure negative emotions in adults, according to three subscales: depression, anxiety and stress.	2 months
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.	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activity monitor (ActiGraph)	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.	1 month
Activity monitor diary	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.	1 month
Demographic form	The form will be used to collect demographic information for both primary caregivers and their children	Baseline

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: Shaqra University
• Investigators: Principal Investigator: Hetaf A Alammar, PhD student, University of Leeds

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: August 9, 2016
• First Submitted That Met QC Criteria: August 15, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Estimate): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 31, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Children; Randomised controlled trial; Attention Deficit Hyperactivity Disorder; Saudi Arabia; Behavioural Insomnia; Behavioural interventions; Sleep difficulties
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Neurodevelopmental Disorders
• Other Study ID Numbers: 0000 (Centre for care Science, KI, Norrbacka Eugeniastiftelsen)