Attention Deficit Disorder With Hyperactivity, Attention Deficit Hyperactivity Disorders, Neurodevelopmental Disorders
Conditions
Keywords
Behavioural interventions, Sleep difficulties, Children, Attention Deficit Hyperactivity Disorder, Randomised controlled trial, Saudi Arabia, Behavioural Insomnia
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?
Interventions
BEHAVIORALGood 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.
Sponsors
Shaqra University
University of Leeds
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Demographic form | Baseline | The form will be used to collect demographic information for both primary caregivers and their children |
| Activity monitor (ActiGraph) | 1 month | 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. |
| Activity monitor diary | 1 month | 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. |
Outcome results
None listed