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

U

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

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.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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