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

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02871674
• Other study ID #: 0000
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 9, 2016
• Last updated: January 31, 2017
• Start date: October 2016
• Est. completion date: August 2017

Study information

• Verified date: January 2017
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Attention Deficit Hyperactivity Disorders
• Disease
• Hyperkinesis
• Neurodevelopmental Disorders

Intervention

Behavioral:
• Good 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	Shaqra University, Saudi Arabia

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Activity monitor diary	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
Other	Demographic form	The form will be used to collect demographic information for both primary caregivers and their children	Baseline
Primary	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
Primary	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	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
Secondary	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
Secondary	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