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

University of Leeds

Status: Unknown

Conditions: Attention Deficit Disorder With Hyperactivity; Neurodevelopmental Disorders; Attention Deficit Hyperactivity Disorders

Treatments: Behavioral: Good Night Project

Study type: Interventional

Funder types: Other

Identifiers

NCT02871674

0000

Details and patient eligibility

About

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?

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Intervention group

Experimental group

Description:

Participants in the intervention group will receive behavioural training by psychologists in three sessions over three weeks

Treatment:

Behavioral: Good Night Project

Control group - usual care

No Intervention group

Description:

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.