A Brief Parent-based Sleep Intervention for ADHD Children

NCT ID: NCT03263156

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Sleep hygiene practices and behavioural intervention

Intervention Type: 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.

Waiting-list control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sleep hygiene practices and behavioural intervention

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 Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. Shirley Xin Li

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shirley Xin Li, PhD,DClinPsy

Role: PRINCIPAL_INVESTIGATOR

Department of Psychology, The University of Hong Kong

Locations

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

Hong Kong, , Hong Kong

Site Status: RECRUITING

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

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Shirley Xin Li, PhD,DClinPsy

Role: CONTACT

shirley.li@hku.hk

852-39177035

Facility Contacts

Kelly YC Lai, MRCPsych,FHKAM(Psych)

Role: primary

kellylai@cuhk.edu.hk

(852)26076025

Ka Sin Caroline Shea, FHKCPsy

Role: backup

carolinesks@gmail.com

(852)26076724

Shirley Xin Li, PhD,DClinPsy

Role: primary

shirley.li@hku.hk

852-39177035

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

30160604

Identifier Type: -

Identifier Source: org_study_id