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A Brief Parent-based Sleep Intervention for ADHD Children

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03263156
Enrollment
60
Registered
2017-08-28
Start date
2017-04-01
Completion date
2021-12-31
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, Insomnia

Keywords

sleep, ADHD, behavioural intervention, insomnia

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.

Interventions

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.

Sponsors

Chinese University of Hong Kong
CollaboratorOTHER
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Child: Change of child's sleepBaseline, 1-week and 3-month posttreatmentChange 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

MeasureTime frameDescription
Child: Change of other sleep measuresBaseline, 1-week and 3-month posttreatmentDaily sleep diary and actigraphic assessment for consecutive seven days
Child: Change of ADHD symptomsBaseline, 1-week and 3-month posttreatmentStrengths and Weaknesses of ADHD Symptoms (SWAN) - parent report
Child: Change of child's behaviour & other clinical symptomsBaseline, 1-week and 3-month posttreatmentStrengths and Difficulties Questionnaire - parent report; Child Behavior Checklist (CBCL) - parent report
Child: Change of quality of lifeBaseline, 1-week and 3-month posttreatmentPediatric Quality of Life Inventory 4.0 - parent proxy report (PedsQL) - parent report
Child: Change of cognitive performance (sustained attention)Baseline, 1-week and 3-month posttreatmentContinuous Performance Test (CPT)
Child: Change of cognitive performance (auditory attention span)Baseline, 1-week and 3-month posttreatmentDigit Span
Child: Change of cognitive performance (working memory)Baseline, 1-week and 3-month posttreatmentN-back
Child: Change of cognitive performance (cognitive processing)Baseline, 1-week and 3-month posttreatmentLetter-digit substitution task
Child: Change of cognitive performance (cognitive flexibility)Baseline, 1-week and 3-month posttreatmentBergs Card Sorting Test (BCST)
Child: Change of daytime sleepinessBaseline, 1-week and 3-month posttreatmentPediatric Daytime Sleepiness Scale (PDSS) - parent report
Change of parental self-reported sleep qualityBaseline, 1-week and 3-month posttreatmentPittsburgh Sleep Quality Index (PSQI)
Change of parental insomnia symptomsBaseline, 1-week and 3-month posttreatmentInsomnia Severity Index (ISI)
Change of parental daytime sleepinessBaseline, 1-week and 3-month posttreatmentEpworth Sleepiness Questionnaire (ESS)
Change of parental sleep parameters as measured by actigraphyBaseline, 1-week and 3-month posttreatmentActigraphic sleep parameters
Change of parental sleep hygiene practiceBaseline, 1-week and 3-month posttreatmentSleep Hygiene Index (SHI)
Change of parental stressBaseline, 1-week and 3-month posttreatmentParental Stress Index - Short Form (PSI-SF)
Change of parental mood symptomsBaseline, 1-week and 3-month posttreatmentDepression Anxiety Stress Scales - 21 item (DASS-21)
Change of parental daytime fatigueBaseline, 1-week and 3-month posttreatmentMultidimensional Fatigue Inventory (MFI)
Parent's satisfaction to the treatmentBaseline, 1-week and 3-month posttreatmentTreatment satisfaction rating scale
Child: Change of cognitive performance (planning skills)Baseline, 1-week and 3-month posttreatmentTower of London (TOL)

Countries

Hong Kong

Contacts

Primary ContactShirley Xin Li, PhD,DClinPsy
shirley.li@hku.hk852-39177035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026