Can a sleep intervention improve outcomes for children with attention-deficit hyperactivity disorder (ADHD)?
| ISRCTN | ISRCTN68819261 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68819261 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/04/2010
- Registration date
- 15/06/2010
- Last edited
- 04/02/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Harriet Hiscock
Scientific
Scientific
Flemington Road
Parkville
3052
Australia
| Phone | +61 (0)3 9345 6910 |
|---|---|
| harriet.hiscock@rch.org.au |
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Impact of a sleep intervention in children with attention-deficit hyperactivity disorder (ADHD): a randomised controlled trial |
| 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(s) | 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 |
| 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 |
| Primary outcome measure | 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 study start date | 01/05/2010 |
| Overall study end date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 12 Years |
| Sex | Both |
| Target number of participants | 248 participants (124 randomised to intervention arm; 124 randomised to control arm) |
| 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 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
Study participating centre
Flemington Road
Parkville
3052
Australia
3052
Australia
Sponsor information
Murdoch Childrens Research Institute (MCRI) (Australia)
Research organisation
Research organisation
Flemington Road
Parkville
3052
Australia
| Phone | +61 (0)3 8341 6200 |
|---|---|
| mcri@mcri.edu.au | |
| Website | http://www.mcri.edu.au/ |
"ROR" |
https://ror.org/048fyec77 |
Funders
Funder type
Research council
National Health and Medical Research Council (NHMRC) (Australia) (ref: 607362)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/01/2015 | Yes | No |
