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Sleeping Sound with Attention deficit hyperactivity disorder (ADHD)

Does a brief, behavioural sleep intervention, delivered by trained paediatricians and psychologists improve sleep, ADHD symptom severity and behaviour for children with ADHD? A cluster-randomised, translational trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN50834814
Enrollment
320
Registered
2014-11-17
Start date
2015-01-28
Completion date
Unknown
Last updated
2019-02-11

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

Conditions

Attention deficit hyperactivity disorder (ADHD) Mental and Behavioural Disorders Disturbance of activity and attention

Interventions

1. Behavioural sleep intervention (intervention group): Families in the intervention group will be offered two face-to-face, fortnightly sleep consultations with their paediatrician (o

Sponsors

Murdoch Children's Research Institute (Australia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria as of 13/01/2017 Families of children aged 5 - 12 years (either sex) with caregiver report of: 1. Moderate to severe sleep problems 2. ADHD symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for ADHD (child also needs to have been previously diagnosed with ADHD by a paediatrician) 3. At least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2014): 3.1 Chronic insomnia disorder 3.2 Sleep-wake phase disorder 3.3 Sleep-related anxiety” Original inclusion criteria: Families of children aged 5 - 12 years (either sex) with caregiver report of: 1. Moderate to severe sleep problems 2. ADHD symptoms meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for ADHD (child also needs to have been previously diagnosed with ADHD by a paediatrician) 3. At least one of the following sleep problems as defined by the American Academy of Sleep Medicine diagnostic criteria (2005): 3.1. Sleep onset association disorder 3.2. Limit setting disorder 3.3. Delayed sleep phase 3.4. Primary insomnia 3.5 Anxiety-associated insomnia

Exclusion criteria

Exclusion criteria: Potential participants will be excluded from the study if they meet any of the following conditions: 1. Suspected obstructive sleep apnoea as screened by three obstructive sleep apnoea items from the Child Sleep Habits Questionnaire (CSHQ) and interview with CI Hiscock (paediatrician) 2. Have a major illness (e.g. cerebral palsy) or disability (e.g. intellectual disability) 3. Non-English speaking

Design outcomes

Primary

MeasureTime frame
Parent report of child sleep problem at 3 month follow up

Secondary

MeasureTime frame
Child secondary outcome measures include: 1. Sleep: Parent report of child sleep patterns as measured by the Child Sleep Habits Questionnaire at 3 months; sleep problem and patterns at 6 month follow up, teacher report of daytime sleepiness at 3 & 6 month follow up 2. ADHD symptoms (parent and teacher report), measured at 3 & 6 months follow up 2. Psychosocial quality of life (parent report), measured at 6 month follow up 3. Behaviour (parent and teacher report), measured at 3 & 6 months follow up 4. Working memory (blinded, direct assessment), measured at 6 month follow up 5. Academic functioning (blinded, direct assessment), measured at 6 month follow up Added 30/08/2016: 6. Executive functioning and learning (blinded, direct assessment), measured at 6 month follow up Parent secondary outcome measures include: 1. Parent mental health, measured at 6 month follow up 2. Parenting behaviours, measured at 6 month follow up

Countries

Australia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026