A Brief Parent-based Sleep Intervention for ADHD Children

Study Overview
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Brief Summary
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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.

Official Title
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Effects of a Brief Parent-based Sleep Intervention for Children With Attention Deficit Hyperactivity Disorder

Conditions
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ADHD, Insomnia

Intervention / Treatment
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* Behavioral: Sleep hygiene practices and behavioural intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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<br>* 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.<br>|
| No Intervention: Waiting-list control<br>Children in the waiting-list control group will receive usual clinical care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child: Change of daytime sleepiness | Pediatric Daytime Sleepiness Scale (PDSS) - parent report | Baseline, 1-week and 3-month posttreatment | 
| Child: Change of other sleep measures | Daily sleep diary and actigraphic assessment for consecutive seven days | Baseline, 1-week and 3-month posttreatment | 
| Child: Change of ADHD symptoms | Strengths and Weaknesses of ADHD Symptoms (SWAN) - parent report | 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 | 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 | Baseline, 1-week and 3-month posttreatment | 
| Child: Change of cognitive performance (sustained attention) | Continuous Performance Test (CPT) | Baseline, 1-week and 3-month posttreatment | 
| Child: Change of cognitive performance (auditory attention span) | Digit Span | Baseline, 1-week and 3-month posttreatment | 
| Child: Change of cognitive performance (working memory) | N-back | Baseline, 1-week and 3-month posttreatment | 
| Child: Change of cognitive performance (cognitive processing) | Letter-digit substitution task | Baseline, 1-week and 3-month posttreatment | 
| Child: Change of cognitive performance (cognitive flexibility) | Bergs Card Sorting Test (BCST) | Baseline, 1-week and 3-month posttreatment | 
| Child: Change of cognitive performance (planning skills) | Tower of London (TOL) | Baseline, 1-week and 3-month posttreatment | 
| Change of parental self-reported sleep quality | Pittsburgh Sleep Quality Index (PSQI) | Baseline, 1-week and 3-month posttreatment | 
| Change of parental insomnia symptoms | Insomnia Severity Index (ISI) | Baseline, 1-week and 3-month posttreatment | 
| Change of parental daytime sleepiness | Epworth Sleepiness Questionnaire (ESS) | Baseline, 1-week and 3-month posttreatment | 
| Change of parental sleep parameters as measured by actigraphy | Actigraphic sleep parameters | Baseline, 1-week and 3-month posttreatment | 
| Change of parental sleep hygiene practice | Sleep Hygiene Index (SHI) | Baseline, 1-week and 3-month posttreatment | 
| Change of parental stress | Parental Stress Index - Short Form (PSI-SF) | Baseline, 1-week and 3-month posttreatment | 
| Change of parental mood symptoms | Depression Anxiety Stress Scales - 21 item (DASS-21) | Baseline, 1-week and 3-month posttreatment | 
| Change of parental daytime fatigue | Multidimensional Fatigue Inventory (MFI) | Baseline, 1-week and 3-month posttreatment | 
| Parent's satisfaction to the treatment | Treatment satisfaction rating scale | Baseline, 1-week and 3-month posttreatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep, ADHD, behavioural intervention, insomnia