An interventional study of Sleep hygiene practices and behavioural intervention in ADHD and Insomnia, sponsored by The University of Hong Kong. Status unknown at 2 sites in Hong Kong. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2021-04-27.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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
Children in the waiting-list control group will receive usual clinical care.
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.
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)
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of daytime sleepiness
Pediatric Daytime Sleepiness Scale (PDSS) - parent report
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of other sleep measures
Daily sleep diary and actigraphic assessment for consecutive seven days
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of ADHD symptoms
Strengths and Weaknesses of ADHD Symptoms (SWAN) - parent report
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of child's behaviour & other clinical symptoms
Strengths and Difficulties Questionnaire - parent report; Child Behavior Checklist (CBCL) - parent report
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of quality of life
Pediatric Quality of Life Inventory 4.0 - parent proxy report (PedsQL) - parent report
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (sustained attention)
Continuous Performance Test (CPT)
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (auditory attention span)
Digit Span
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (working memory)
N-back
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (cognitive processing)
Letter-digit substitution task
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (cognitive flexibility)
Bergs Card Sorting Test (BCST)
Time frame: Baseline, 1-week and 3-month posttreatment
Child: Change of cognitive performance (planning skills)
Tower of London (TOL)
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental self-reported sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental insomnia symptoms
Insomnia Severity Index (ISI)
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental daytime sleepiness
Epworth Sleepiness Questionnaire (ESS)
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental sleep parameters as measured by actigraphy
Actigraphic sleep parameters
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental sleep hygiene practice
Sleep Hygiene Index (SHI)
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental stress
Parental Stress Index - Short Form (PSI-SF)
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental mood symptoms
Depression Anxiety Stress Scales - 21 item (DASS-21)
Time frame: Baseline, 1-week and 3-month posttreatment
Change of parental daytime fatigue
Multidimensional Fatigue Inventory (MFI)
Time frame: Baseline, 1-week and 3-month posttreatment
Parent's satisfaction to the treatment
Treatment satisfaction rating scale
Time frame: Baseline, 1-week and 3-month posttreatment
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Sleep Initiation and Maintenance Disorders→
The University of Hong Kong