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

Not Applicable

• Conditions: Attention Deficit Disorder With Hyperactivity; Attention Deficit Hyperactivity Disorders; Neurodevelopmental Disorders
• Interventions: Behavioral: Good Night Project

• Registration Number: NCT02871674
• Lead Sponsor: 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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-18
• Study Start: 2016-10
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Good Night Project	Participants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks

Primary Outcome Measures

Name	Time	Method
Conners' Parent Rating Scale-48 (CPRS-48)	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 Children's Sleep Habits Questionnaire CSHQ	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.

Secondary Outcome Measures

Name	Time	Method
Conners' Teachers Rating Scale-28 (CTRS-28)	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.
The Sleep Disorders Scale for primary caregivers	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	2 months	This is designed to measure negative emotions in adults, according to three subscales: depression, anxiety and stress.