Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000344392
Ethics application status
Not yet submitted
Date submitted
12/06/2008
Date registered
22/07/2008
Date last updated
25/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Sleeping sound with Attention Deficit Hyperactivity Disorder (ADHD)
Scientific title
Can managing sleep problems in children with Attention Deficit Hyperactivity Disorder (ADHD) improve child sleep, behaviour, quality of life, and school attendance? – a pilot study
Secondary ID [1] 631 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention Deficit Hyperactivity Disorder 3256 0
Condition category
Condition code
Mental Health 3421 3421 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this pilot study is to determine the acceptability and feasibility of two different models of managing sleep problems in children with ADHD.
The models differ in level of intensity of the treatment given. The first model (intensive model) consists of basic sleep hygiene strategies, education about normal sleep and sleep cycles, tailored sleep management plan, and sleep diary. These interventions will be delivered in the first consultation (each consultation will be 40 minutes long). The second session will take place approximately two weeks after their initial consultation to reinforce strategies and monitor progress. Families will be contacted by telephone approximately two weeks after this visit to refine strategies and to make a third appointment if the family are continuing to have difficulties.
Intervention code [1] 2996 0
Behaviour
Comparator / control treatment
Active - The second model is a one session model of treating sleep problems - basic sleep hygiene strategies, education about normal sleep and sleep cycles, given generic written information around common sleep problems. This intervention will take place one 40 minute consultation. These families will not receive further face to face or telephone follow-up.
Control group
Active

Outcomes
Primary outcome [1] 4315 0
The acceptability, frequency of use and ease of use of each component of the intervention as per our previous RCTs (Hiscock H et al Arch. Dis. Child. 2007 92: p. 952-958; Hiscock H et al BMJ, 2002;324:1062-1067). Parents will be asked to rate how helpful they found various components of the program on a four point scale (very helpful, a little helpful, not helpful, didn't receive this advice). Parents will also be asked to rate how often they were able to put the advice received into practice on a 5 point scale (almost all of the time, about half of the time, about a quater of the time, less than a quater of the time, did not receive this advice)
Timepoint [1] 4315 0
2 months post randomisation
Primary outcome [2] 4316 0
Barriers to participation in the study, attendance at consultations and uptake of interventions as per our previous parenting RCT (Hiscock H et al Arch. Dis. Child. 2007 92: p. 952-958; Hiscock H et al BMJ, 2002;324:1062-1067). Parent will be asked what were the best and worst things about the program, how we could improve the program, and if they would recommend this program to friends/family.
Timepoint [2] 4316 0
2 months post randomisation
Secondary outcome [1] 7272 0
Primary caregiver report of child sleep problem - none, mild, moderate or severe. This question is used in the Longitudinal Study of Australian Children to monitor parental concerns about their child's sleep.
Timepoint [1] 7272 0
2 & 5 months post randomisation
Secondary outcome [2] 7273 0
Children's Sleep Habits Questionnaire - validated 33-item measure of dyssomnias and parasomnias
Timepoint [2] 7273 0
2 & 5 months post randomisation
Secondary outcome [3] 7274 0
Pediatric Quality of Life Inventory 4.0-Parent version (Peds-QL) - validated 23-item measure of child health-related quality of life including physical, emotional, social, and school functioning.
Timepoint [3] 7274 0
2 & 5 months post randomisation
Secondary outcome [4] 7275 0
School attendance - over the preceding 6 months
Timepoint [4] 7275 0
2 & 5 months post randomisation
Secondary outcome [5] 7276 0
Depression Anxiety Stress Scale - validated 21-item measure of adult depression, anxiety and stress.
Timepoint [5] 7276 0
2 & 5 months post randomisation
Secondary outcome [6] 7277 0
Caregiver work attendance - over the previous 6 months
Timepoint [6] 7277 0
2 & 5 months post randomisation
Secondary outcome [7] 7278 0
Child Health Questionnaire (CHQ) PF5014 - emotional impact, time impact and family activities subscales.
Timepoint [7] 7278 0
2 & 5 months post randomisation

Eligibility
Key inclusion criteria
1) School aged children with ADHD who have a moderate/severe sleep problem by primary caregiver report
2) Children must meet the American Academy of Sleep Medicine diagnostic criteria for any of the following: sleep onset association disorder, limit setting disorder, delayed sleep phase, primary insomnia or anxiety.
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with suspected obstructive sleep apnoea identified from parental responses to the 3 items in the Child Sleep Habits Questionnaire, (which screens for obstructive sleep apnoea) will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The research assistant will then explain the pilot to eligible families. Interested families will be mailed a baseline package including: (1) parent information statement, (2) two written informed consent forms – one to sign and keep, the other to return to the study team, (3) baseline survey and (4) a reply-paid envelope. We will seek approval from the Royal Children’s Hospital’s Ethics in Human Research Committee to conduct this project. Upon receipt of the signed consent form and baseline survey, families will be randomly allocated to either a one session education-based model or a 2 to 3 session intensive management model. Families will be randomised using a pregenerated random number sequence provided by an independent statistician from the hospital’s Clinical Epidemiology and Biostatistics Unit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software (i.e., computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3479 0
Charities/Societies/Foundations
Name [1] 3479 0
Foundation for Children
Country [1] 3479 0
Australia
Primary sponsor type
Hospital
Name
Centre for Community Child Health
Address
The Royal Children's Hospital
Flemington Road, Parkville Vic 3052
Country
Australia
Secondary sponsor category [1] 3122 0
Hospital
Name [1] 3122 0
Murdoch Children's Research Institute
Address [1] 3122 0
The Royal Children's Hospital
Flemington Road, Parkville Vic 3052
Country [1] 3122 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5509 0
The Royal Children's Hospital (RCH) Human Research Ethics Committee
Ethics committee address [1] 5509 0
Ethics committee country [1] 5509 0
Australia
Date submitted for ethics approval [1] 5509 0
09/05/2008
Approval date [1] 5509 0
Ethics approval number [1] 5509 0
28067

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28664 0
Address 28664 0
Country 28664 0
Phone 28664 0
Fax 28664 0
Email 28664 0
Contact person for public queries
Name 11821 0
Harriet Hiscock
Address 11821 0
Centre for Community Child Health
The Royal Children's Hospital
Flemington Road, Parkville Vic 3052
Country 11821 0
Australia
Phone 11821 0
93456910
Fax 11821 0
93455900
Email 11821 0
[email protected]
Contact person for scientific queries
Name 2749 0
Harriet Hiscock
Address 2749 0
Centre for Community Child Health
The Royal Children's Hospital
Flemington Road, Parkville Vic 3052
Country 2749 0
Australia
Phone 2749 0
93456910
Fax 2749 0
93455900
Email 2749 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.