A Brief Parent-based Sleep Intervention for ADHD Children

NCT03263156 | Unknown

• 1 other identifier: 30160604
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Sleep problems are very common in children with ADHD, with a prevalence rate as high as 73%, and often pose significant challenges and stress to the families. Sleep problems in ADHD children are strongly associated with the exacerbation of daytime symptoms, impaired physical health, and poor parental mental health. The present study is a randomised controlled trial to compare the effects of a parent-based sleep intervention for children with ADHD (aged 6-12). Eligible participants will be randomised to either intervention (two face-to-face consultation sessions and one follow-up phone call) or waiting-list control condition. Assessments will be conducted at pre-treatment (baseline), one-week after the intervention (post-treatment), and 3 months after the intervention.

Conditions

ADHD; Insomnia

Keywords

sleep; ADHD; behavioural intervention; insomnia

Outcome Measures

Primary Outcomes (1)

• Child: Change of child's sleep

  Change of the child's sleep measured by the Children's Sleep Habits Questionnaire (CSHQ), and sleep problems rated by parent (none, mild, moderate, severe)

  Baseline, 1-week and 3-month posttreatment

Secondary Outcomes (20)

• Child: Change of daytime sleepiness

  Baseline, 1-week and 3-month posttreatment

• Child: Change of other sleep measures

  Baseline, 1-week and 3-month posttreatment

• Child: Change of ADHD symptoms

  Baseline, 1-week and 3-month posttreatment

• Child: Change of child's behaviour & other clinical symptoms

  Baseline, 1-week and 3-month posttreatment

• Child: Change of quality of life

  Baseline, 1-week and 3-month posttreatment

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention will involve two face-to-face consultation sessions and one follow-up phone call with parents to help them learn sleep hygiene practices and specific behavioural strategies to improve their child's sleep and follow up on the progress.

Behavioral: Sleep hygiene practices and behavioural intervention

Waiting-list control

NO INTERVENTION

Children in the waiting-list control group will receive usual clinical care.

Interventions

Sleep hygiene practices and behavioural intervention BEHAVIORAL

The first session will involve the provision of sleep-related psycho-education (e.g. sleep hygiene practices) and specific strategies to tackle problematic sleep-related behaviours, as well as collaborative goal setting and development of management plan tailored to the child's sleep problem for the next two weeks. The second session will involve a review of the sleep diary and a reinforcement of learned strategies, and focus on problem-solving to tackle any issues that have emerged from implementing the behavioural strategies at home. A follow-up phone call will be made two weeks later to provide parents with an opportunity to ask any further questions and to consolidate learned strategies and further troubleshoot.

Intervention group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 6-12 years old;
• With a clinical diagnosis of ADHD (any subtype), as confirmed by the Diagnostic Interview Schedule for Children-version-IV (DISC-IV);
• With parent-reported insomnia (difficulty initiating sleep and/or maintaining sleep).

You may not qualify if:

• Children with a serious medical condition (e.g. severe cerebral palsy) or intellectual disability (IQ\<70);
• Children with a neurological and/or medical condition that may lead to disordered sleep;
• Suspected clinical sleep disorders (e.g. obstructive sleep apnea, OSA) that may potentially contribute to a disruption in sleep continuity and quality, as assessed by the Children's Sleep Habits Questionnaire (CSHQ). If the child is suspected of a clinical sleep disorder, he/she will be referred to appropriate services;
• Children who are already receiving specialised help (behavioural intervention) for their sleep from a psychologist or at a specialized sleep clinic.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Chinese University of Hong Kong: collaborator

Study Sites (2)

Child and Adolescent Psychiatric Service Clinic, New Territories East Cluster (NTEC), Hospital Authority

Hong Kong, Hong Kong

RECRUITING

Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Shirley Xin Li, PhD,DClinPsy

  Department of Psychology, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley Xin Li, PhD,DClinPsy

CONTACT

852-39177035; shirley.li@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 28, 2017
• Study Start: April 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)