Clinical trial NCT03263156: A Brief Parent-based Sleep Intervention for ADHD Children
Official title: Effects of a Brief Parent-based Sleep Intervention for Children With Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ADHD
Insomnia
Keywords: sleep
ADHD
behavioural intervention
insomnia
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2017-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Child: Change of child's sleep
timeFrame: Baseline, 1-week and 3-month posttreatment
Secondary outcomes:
measure: Child: Change of daytime sleepiness
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Child: Change of other sleep measures
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Child: Change of ADHD symptoms
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Child: Change of child's behaviour & other clinical symptoms
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Child: Change of quality of life
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Child: Change of cognitive performance (sustained attention)
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Child: Change of cognitive performance (auditory attention span)
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Child: Change of cognitive performance (working memory)
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Child: Change of cognitive performance (cognitive processing)
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Child: Change of cognitive performance (cognitive flexibility)
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Child: Change of cognitive performance (planning skills)
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Change of parental self-reported sleep quality
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Change of parental insomnia symptoms
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Change of parental daytime sleepiness
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Change of parental sleep parameters as measured by actigraphy
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Change of parental sleep hygiene practice
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Change of parental stress
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Change of parental mood symptoms
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Change of parental daytime fatigue
timeFrame: Baseline, 1-week and 3-month posttreatment
measure: Parent's satisfaction to the treatment
timeFrame: Baseline, 1-week and 3-month posttreatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Child and Adolescent Psychiatric Service Clinic, New Territories East Cluster (NTEC), Hospital Authority
city: Hong Kong
country: Hong Kong
facility: Sleep Research Clinic & Laboratory, Department of Psychology, The University of Hong Kong
Study officials:
affiliation: Department of Psychology, The University of Hong Kong
name: Shirley Xin Li, PhD,DClinPsy
role: PRINCIPAL_INVESTIGATOR
References: