Parenting matters: helping parents with young children
| ISRCTN | ISRCTN81511074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN81511074 |
| ClinicalTrials.gov number | NCT00133055 |
| Secondary identifying numbers | MCT-67816 |
- 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
Scientific
Social Sciences Centre
1151 Richmond Street
SSC 7310
University of Western Ontario
London, Ontario
N6A 5C2
Canada
| Phone | +1 519 661 2111 (84677) |
|---|---|
| greid@uwo.ca |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2005 |
| Completion date | 31/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 480 (Added 09/08/2011: 548 actually recruited) |
| 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
N6A 5C2
Canada
Sponsor information
University of Western Ontario (Canada)
University/education
University/education
1151 Richmond Street North
London, Ontario
N6A 3K7
Canada
"ROR" |
https://ror.org/02grkyz14 |
|---|
Funders
Funder type
Research organisation
Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-67816)
No information available
The Provincial (Ontario) Centre of Excellence for Child and Youth Mental Health at CHEO (Canada)
No information available
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 | 01/02/2013 | Yes | No |
