A Brief Parent-based Sleep Intervention for ADHD Children

Sponsor
The University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT03263156
Collaborator
Chinese University of Hong Kong (Other)
60
2
2
57
30
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Sleep hygiene practices and behavioural intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of a Brief Parent-based Sleep Intervention for Children With Attention Deficit Hyperactivity Disorder
Actual Study Start Date :
Apr 1, 2017
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

No Intervention: Waiting-list control

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

Outcome Measures

Primary Outcome Measures

  1. Child: Change of child's sleep [Baseline, 1-week and 3-month posttreatment]

    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)

Secondary Outcome Measures

  1. Child: Change of daytime sleepiness [Baseline, 1-week and 3-month posttreatment]

    Pediatric Daytime Sleepiness Scale (PDSS) - parent report

  2. Child: Change of other sleep measures [Baseline, 1-week and 3-month posttreatment]

    Daily sleep diary and actigraphic assessment for consecutive seven days

  3. Child: Change of ADHD symptoms [Baseline, 1-week and 3-month posttreatment]

    Strengths and Weaknesses of ADHD Symptoms (SWAN) - parent report

  4. Child: Change of child's behaviour & other clinical symptoms [Baseline, 1-week and 3-month posttreatment]

    Strengths and Difficulties Questionnaire - parent report; Child Behavior Checklist (CBCL) - parent report

  5. Child: Change of quality of life [Baseline, 1-week and 3-month posttreatment]

    Pediatric Quality of Life Inventory 4.0 - parent proxy report (PedsQL) - parent report

  6. Child: Change of cognitive performance (sustained attention) [Baseline, 1-week and 3-month posttreatment]

    Continuous Performance Test (CPT)

  7. Child: Change of cognitive performance (auditory attention span) [Baseline, 1-week and 3-month posttreatment]

    Digit Span

  8. Child: Change of cognitive performance (working memory) [Baseline, 1-week and 3-month posttreatment]

    N-back

  9. Child: Change of cognitive performance (cognitive processing) [Baseline, 1-week and 3-month posttreatment]

    Letter-digit substitution task

  10. Child: Change of cognitive performance (cognitive flexibility) [Baseline, 1-week and 3-month posttreatment]

    Bergs Card Sorting Test (BCST)

  11. Child: Change of cognitive performance (planning skills) [Baseline, 1-week and 3-month posttreatment]

    Tower of London (TOL)

  12. Change of parental self-reported sleep quality [Baseline, 1-week and 3-month posttreatment]

    Pittsburgh Sleep Quality Index (PSQI)

  13. Change of parental insomnia symptoms [Baseline, 1-week and 3-month posttreatment]

    Insomnia Severity Index (ISI)

  14. Change of parental daytime sleepiness [Baseline, 1-week and 3-month posttreatment]

    Epworth Sleepiness Questionnaire (ESS)

  15. Change of parental sleep parameters as measured by actigraphy [Baseline, 1-week and 3-month posttreatment]

    Actigraphic sleep parameters

  16. Change of parental sleep hygiene practice [Baseline, 1-week and 3-month posttreatment]

    Sleep Hygiene Index (SHI)

  17. Change of parental stress [Baseline, 1-week and 3-month posttreatment]

    Parental Stress Index - Short Form (PSI-SF)

  18. Change of parental mood symptoms [Baseline, 1-week and 3-month posttreatment]

    Depression Anxiety Stress Scales - 21 item (DASS-21)

  19. Change of parental daytime fatigue [Baseline, 1-week and 3-month posttreatment]

    Multidimensional Fatigue Inventory (MFI)

  20. Parent's satisfaction to the treatment [Baseline, 1-week and 3-month posttreatment]

    Treatment satisfaction rating scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Child and Adolescent Psychiatric Service Clinic, New Territories East Cluster (NTEC), Hospital Authority Hong Kong Hong Kong
2 Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong Hong Kong Hong Kong

Sponsors and Collaborators

  • The University of Hong Kong
  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Shirley Xin Li, PhD,DClinPsy, Department of Psychology, The University of Hong Kong

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Dr. Shirley Xin Li, Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT03263156
Other Study ID Numbers:
  • 30160604
First Posted:
Aug 28, 2017
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Shirley Xin Li, Assistant Professor, The University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2021