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

• 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

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.