Contact information
Type
Scientific
Primary contact
Dr Graham James Reid
ORCID ID
Contact details
Social Sciences Centre
1151 Richmond Street
SSC 7310
University of Western Ontario
London
Ontario
N6A 5C2
Canada
+1 519 661 2111 (84677)
greid@uwo.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00133055
Protocol/serial number
MCT-67816
Study information
Scientific title
Acronym
Study hypothesis
We hypothesise that parents receiving treatment booklets addressing sleep and bedtime behaviours (Trial 1) or discipline problems (Trial 2) and telephone support, along with usual care by their family physician, will demonstrate greater reductions in sleep or discipline problems, improved parenting practices, and greater reductions in child behaviour problems in general following the intervention compared to parents receiving usual medical care.
Ethics approval
The University of Western Ontario Research Ethics Board for Health Sciences Research Involving Human Subjects (HSREB), 08/11/2004
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Discipline and Sleep Problems
Intervention
Intervention group in each trial (trial 1 - [sleep], trial 2 [discipline] and trial 3 [both sleep and discipline]) will receive by mail a problem-specific self-help treatment booklet. Trial 3 participants will receive one of the two treatment booklets. Furthermore all of them will receive telephone support (three phone calls in total over six week treatment period) in addition to usual care by a family physician.
Control group: Usual care by a family physician.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
There are separate primary outcomes measured for each trial:
Sleep and bedtime problems trial (Trial 1): Parent report on the Children's Sleep Habits Questionnaire
Discipline problems trial (Trial 2): Parent rated total problem score on the Eyberg Child Behavior Inventory
Sleep and Discipline problems trial (Trial 3): Parent report on the Children's Sleep Habits Questionnaire (Group 1 Sleep treatment) and Parent rated total problem score on the Eyberg Child Behavior Inventory (Group 2 Discipline treatment)
Secondary outcome measures
1. Parenting practices - Total score on the Parenting Scale
2. General child behavior problems - Total problem score on the Child Behavior Checklist
3. Daily recall ratings of sleep and discipline problems (four reports in total)
4. Parent report on the Richman sleep questionnaire (only for trial 1 [sleep and bedtime problems] and for trial 3 participants if in sleep treatment condition)
Overall trial start date
01/01/2005
Overall trial end date
31/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
Parents of children aged two to five years of either sex with concerns about their childs sleep (trial 1), discipline (trial 2), or sleep and discipline (trial 3):
1. Parent (primary caregiver) of 2 - 5 year old child
2. Attending a medical appointment at a family medical practice
3. Phone in home
4. Parent concerned about childs sleep and/or discipline
5. Parent interested in participating in a treatment study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
480 (Added 09/08/2011: 548 actually recruited)
Participant exclusion criteria
1. Parent non-English speaking
2. Child with significant physical (e.g. cerebral palsy) or developmental (e.g. Down syndrome) disability
3. Parents only sleep concern is in regards to a physiological sleep disorder (e.g. sleep apnea, snoring) or bedwetting
Recruitment start date
01/01/2005
Recruitment end date
31/05/2007
Locations
Countries of recruitment
Canada
Trial participating centre
Social Sciences Centre
London, Ontario
N6A 5C2
Canada
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67816)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Provincial (Ontario) Centre of Excellence for Child and Youth Mental Health at CHEO (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22948337
Publication citations
-
Results
Reid GJ, Stewart M, Vingilis E, Dozois DJ, Wetmore S, Jordan J, Dickie G, Osmun WE, Wade TJ, Brown JB, Zaric GS, Randomized trial of distance-based treatment for young children with discipline problems seen in primary health care., Fam Pract, 2013, 30, 1, 14-24, doi: 10.1093/fampra/cms051.