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

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

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

Conditions
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Attention Deficit Hyperactivity Disorders, Neurodevelopmental Disorders, Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
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* Behavioral: Good Night Project


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Participants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks | Behavioral: Good Night Project<br>* 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.<br>|
| No Intervention: Control group - usual care<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioural interventions, Sleep difficulties, Children, Attention Deficit Hyperactivity Disorder, Randomised controlled trial, Saudi Arabia, Behavioural Insomnia