Parenting matters: helping parents with young children

ISRCTN	ISRCTN81511074
DOI	https://doi.org/10.1186/ISRCTN81511074
ClinicalTrials.gov (NCT)	NCT00133055
Protocol serial number	MCT-67816
Sponsor	University of Western Ontario (Canada)
Funders	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67816), The Provincial (Ontario) Centre of Excellence for Child and Youth Mental Health at CHEO (Canada)

Submission date: 09/08/2005
Registration date: 09/08/2005
Last edited: 09/07/2013

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 of protocol

Not provided at time of registration

Contact information

Dr Graham James Reid
Scientific

Social Sciences Centre
1151 Richmond Street
SSC 7310
University of Western Ontario
London, Ontario
N6A 5C2
Canada

Phone	+1 519 661 2111 (84677)
Email	greid@uwo.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	The University of Western Ontario Research Ethics Board for Health Sciences Research Involving Human Subjects (HSREB), 08/11/2004
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	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)
Completion date	31/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	480
Key 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
Key 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
Date of first enrolment	01/01/2005
Date of final enrolment	31/05/2007

Locations

Countries of recruitment

Canada

Study participating centre

Social Sciences Centre

London, Ontario
N6A 5C2
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/02/2013		Yes	No