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Can a sleep intervention improve outcomes for children with attention-deficit hyperactivity disorder (ADHD)?
ISRCTN ISRCTN68819261
DOI 10.1186/ISRCTN68819261
ClinicalTrials.gov identifier
EudraCT number
Public title Can a sleep intervention improve outcomes for children with attention-deficit hyperactivity disorder (ADHD)?
Scientific title Impact of a sleep intervention in children with attention-deficit hyperactivity disorder (ADHD): a randomised controlled trial
Acronym N/A
Serial number at source N/A
Study hypothesis We hypothesise that, compared to the control group, families randomised to the intervention group will report 3, 6 and 12 months post-intervention:
1. Improved child outcomes including:
1.1. Lower (better) mean score on an attention-deficit hyperactivity disorder (ADHD) symptom scale (primary outcome)
1.2. Lower proportion with sleep problems
1.3. Improved mean scores on continuous measures of working memory, behaviour, health-related quality of life, and school attendance
2. Improved primary caregiver outcomes including:
2.1. Lower proportion of mental health problems on an adult mental health scale
2.2. Improved mean scores on continuous measure of work attendance
Lay summary
Ethics approval Royal Children's Hospital, Melbourne, Australia and Department of Education and Early Childhood Development Human Research Ethics Committees, Victoria, Australia - pending as of 22/04/2010
Study design Single-centre randomised controlled trial
Countries of recruitment Australia
Disease/condition/study domain Attention-deficit hyperactivity disorder (ADHD)
Participants - 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 or anxiety
Participants - exclusion criteria 1. With suspected obstructive sleep apnoea as screened by three obstructive sleep apnoea items from the Child Sleep Habits Questionnaire (CSHQ) and interview with CI Hisock
2. Receiving help from a health professional (e.g. psychologist) specifically for their sleep problem (aside from their treating paediatrician)
Anticipated start date 01/05/2010
Anticipated end date 31/12/2012
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 248 participants (124 randomised to intervention arm; 124 randomised to control arm)
Interventions Behavioural sleep intervention (intervention group):
The behavioural sleep intervention will be delivered by a study-employed paediatrician, child psychologist and/or nurse.

Parent(s) and the child will be seen for two x 50 minute consultations to assess and provide strategies to assist their child's sleep problem. The first session will focus on an assessment of the child's sleep problem, providing information about normal sleep and sleep cycles, advice about sleep hygiene, and a tailored plan specific to the sleep diagnosis. For example, sleep onset association disorder, typically associated with the need for parental presence at sleep time, will be managed with adult fading. This technique requires gradual withdrawal of parental presence from the child's bedroom over 7 - 10 days. Limit setting disorder will be managed by ignoring child protests and rewarding compliance with bedtime routines. Delayed sleep phase will be managed by temporarily setting the child's bedtime later, gradually bringing it forward, and waking the child at a pre-set time in the morning to ensure they do not sleep in.

Families will receive written handouts summarising the session content and will complete a written management plan with the clinician. All families will be asked to complete a sleep diary for their child to facilitate recognition of sleep patterns and improvements and to help set further goals.

The second session will be held two weeks later to reinforce strategies and monitor progress. The sleep clinician will conatct families by telephone two weeks after the second visit to reinforce strategies, trouble shoot and monitor progress.

Usual care (control group):
Families in the usual care group will be able to access usual care for ADHD or their child's sleep from their child's paediatrician and/or other health services.
Primary outcome measure(s) Child's ADHD symptoms: ADHD Rating Scale IV (parent and teacher report), measured at 3, 6, and 12 months post-randomisation.
Secondary outcome measure(s) Secondary child outcome measures include:
1. Sleep problem - none, mild, moderate or severe (parent report), measured at 3, 6, and 12 months post-randomisation
2. Children's Sleep Habits Questionnaire (CSHQ), measured at 3, 6, and 12 months post-randomisation
3. Strengths and Difficulties Questionnaire (SDQ) (parent and teacher report), measured at 3, 6, and 12 months post-randomisation
4. Pediatric Quality of Life Inventory (Peds QL), measured at 3, 6, and 12 months post-randomisation
5. Daily Parent Rating of Evening and Morning Behaviour (DMREB), measured at 3, 6, and 12 months post-randomisation
6. School attendance, measured at 3, 6, and 12 months post-randomisation
7. Other sleep help (eg GP, school nurse), measured at 3, 6, and 12 months post-randomisation
8. Working Memory Test Battery for Children (WMTB-C, a face-to-face measure), measured at 6 months post-randomisation

Secondary primary caregiver outcome measures include:
1. Depression Anxiety Stress Scale (DASS), measured at 3 and 6 months post-randomisation
2. Work attendance, measured at 3 and 6 months post-randomisation
Sources of funding National Health and Medical Research Council (NHMRC) (Australia) (ref: 607362)
Trial website
Publications
Contact name Dr  Harriet  Hiscock
  Address Flemington Road
  City/town Parkville
  Zip/Postcode 3052
  Country Australia
  Tel +61 (0)3 9345 6910
  Fax +61 (0)3 9345 5900
  Email harriet.hiscock@rch.org.au
Sponsor Murdoch Childrens Research Institute (MCRI) (Australia)
  Address Flemington Road
  City/town Parkville
  Zip/Postcode 3052
  Country Australia
  Tel +61 (0)3 8341 6200
  Fax +61 (0)3 9348 1391
  Email mcri@mcri.edu.au
  Sponsor website: http://www.mcri.edu.au/
Date applied 22/04/2010
Last edited 15/06/2010
Date ISRCTN assigned 15/06/2010
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