Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shaqra University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Participants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks |
|
| Control group - usual care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Good Night Project | Behavioral | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Children will be excluded from the study if they meet any of the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hetaf A Alammar, PhD student | University of Leeds | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 |
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 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D065886 | Neurodevelopmental Disorders |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided