Condition category
Mental and Behavioural Disorders
Date applied
22/04/2010
Date assigned
15/06/2010
Last edited
04/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Harriet Hiscock

ORCID ID

Contact details

Flemington Road
Parkville
3052
Australia
+61 (0)3 9345 6910
harriet.hiscock@rch.org.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Impact of a sleep intervention in children with attention-deficit hyperactivity disorder (ADHD): a randomised controlled trial

Acronym

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Attention-deficit hyperactivity disorder (ADHD)

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Child's ADHD symptoms: ADHD Rating Scale IV (parent and teacher report), measured at 3, 6, and 12 months post-randomisation.

Secondary outcome measures

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

Overall trial start date

01/05/2010

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

248 participants (124 randomised to intervention arm; 124 randomised to control arm)

Participant 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)

Recruitment start date

01/05/2010

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Australia

Trial participating centre

Flemington Road
Parkville
3052
Australia

Sponsor information

Organisation

Murdoch Childrens Research Institute (MCRI) (Australia)

Sponsor details

Flemington Road
Parkville
3052
Australia
+61 (0)3 8341 6200
mcri@mcri.edu.au

Sponsor type

Research organisation

Website

http://www.mcri.edu.au/

Funders

Funder type

Research council

Funder name

National Health and Medical Research Council (NHMRC) (Australia) (ref: 607362)

Alternative name(s)

NHMRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25646809

Publication citations

Additional files

Editorial Notes