A Brief Parent-based Sleep Intervention for ADHD Children

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03263156
• Other study ID #: 30160604
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: April 2021
• Source: The University of Hong Kong
• Contact: Shirley Xin Li, PhD,DClinPsy
• Phone: 852-39177035
• Email: shirley.li[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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