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Parenting Matters: Helping Parents With Young Children

Primary Purpose

Sleep Problems, Behavior Problems, Child Behavior

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Self-help treatment booklet and telephone support
Usual care by a family physician
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Problems focused on measuring parenting, sleep problems, behavior problems, brief intervention, self-help, preschool-age children, psychosocial

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Parent (primary caregiver) of a 2-5 year old child Attending a medical appointment at a family medical practice Phone in home Parent concerned about child's sleep and/or discipline Parent interested in participating in a treatment study Exclusion Criteria: Parent non-English speaking Child with significant physical or developmental disability Parent's only sleep concern is in regards to a physiological sleep disorder (e.g. sleep apnea, snoring) or bedwetting No phone

Sites / Locations

  • University of Western Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment booklet and telephone coaching

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

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 Habit Questionnaire (Group 1-sleep treatment) and parent rated total problem score on the Eyberg Child Behavior Inventory (Group 2-discipline treatment)

Secondary Outcome Measures

Parenting practices-total score on the Parenting Scale
General child behavior problems-total problem score on the Child Behavior Checklist
Daily recall ratings of sleep and discipline problems (3 reports in total)
Parent report on the Richman sleep questionnaires (only for Trial 1-sleep and bedtime problems and for Trial 3 participants if in sleep treatment condition)

Full Information

First Posted
August 18, 2005
Last Updated
April 11, 2018
Sponsor
University of Western Ontario, Canada
Collaborators
Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT00133055
Brief Title
Parenting Matters: Helping Parents With Young Children
Official Title
Parenting Matters: Helping Parents With Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Western Ontario, Canada
Collaborators
Canadian Institutes of Health Research (CIHR), Children's Hospital of Eastern Ontario

4. Oversight

5. Study Description

Brief Summary
Sleep and discipline problems are the most common problems for parents of young children (ages 2 to 5 years old) and are the two concerns with the strongest relations to future child behavior problems. The Parenting Matters program combines treatment booklets and telephone support to help parents deal with sleep or discipline problems. Parents with concerns and who are interested in the study are identified during a visit to their family physician. We, the investigators at the University of Western Ontario, expect that parents receiving treatment booklets, along with usual care by their family physician, will have greater reductions in their child's sleep or discipline problems, improved parenting practices, and greater reductions in child behaviour problems after receiving the Parenting Matters intervention, compared to parents receiving usual medical care.
Detailed Description
About 1 in 5 young children (ages 2 to 5 years) has a significant psychosocial problem, but over 80% do not receive treatment. Without treatment, up to half of these children will have problems into childhood and adolescence. New methods of treating and preventing children's psychosocial problems are needed. Sleep and discipline problems (or child non-compliance) are the most common problems for parents of young children, and are the two concerns with the strongest relations to future child behavior problems. Further, parenting practices have consistently been linked to the development of psychosocial problems. The Parenting Matters program combines treatment booklets and telephone support to help parents with sleep or discipline problems among young children. Objectives: Test the efficacy of the Parenting Matters program interventions for sleeping and bedtime behaviors (Trial 1), and discipline (Trial 2) in reducing problem-specific outcomes. Test the effects of the Parenting Matters program interventions for parents who are concerned about both their children's sleep and discipline (Trial 3) in reducing problem-specific outcomes related to sleep (Group 1) and discipline problems (Group 2) will be tested. Test the efficacy of the Parenting Matters program in improving parenting practices. Test the efficacy of the Parenting Matters program in reducing child behaviour problems in general. Examine predictors of treatment success. Method: All parents of 2 to 5 year-olds seen in a family practice for a routine appointment are asked to complete a psychosocial concerns checklist. Parents who have concerns regarding their child's sleep (Trial 1), how to discipline their child (Trial 2), or concerns about both their child's sleep and discipline (Trial 3), and meet the other study criteria, are invited to take part in the study. Mailed baseline assessment packages assess children's behavior, parenting practices and potential predictors of treatment success. Parents are randomized to usual care, or the Parenting Matters program along with usual care. The Parenting Matters program includes treatment booklets addressing either sleep or discipline problems, and telephone coach support (3 calls over 6 weeks). Primary outcomes are parents' ratings of their children's sleep or discipline problems measured at post-treatment (7 weeks after baseline). Parents repeat assessment packages at 3- and 6-month follow-ups. Goals & Relevance: This research addresses the need for new ways of providing early interventions for young children that: reach the largest number of individuals in need; are cost effective; and time efficient. By addressing the most common issues facing parents of young children, it engages parents in areas of direct relevance to them. The program focuses on parenting practices thereby building family strengths that may have a lasting impact on child development. Collaboration with family physicians builds on the ongoing positive relationships between parents and family physicians and provides a mechanism to reach a significant proportion of young children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Problems, Behavior Problems, Child Behavior
Keywords
parenting, sleep problems, behavior problems, brief intervention, self-help, preschool-age children, psychosocial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
548 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment booklet and telephone coaching
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Self-help treatment booklet and telephone support
Intervention Description
The Parenting Matters treatment program consisted of a self-help treatment booklet and two telephone coaching calls from a paraprofessional telephone coach at Weeks 2 and 5 of the program. Two booklets were used in the three trials; one addressed sleep issues and the second discipline problems.
Intervention Type
Behavioral
Intervention Name(s)
Usual care by a family physician
Intervention Description
Parents in the usual care condition were told to continue with care from their family physician and/or any other treatment recommended by the physician.
Primary Outcome Measure Information:
Title
Sleep and bedtime problems trial (Trial 1): parent report on the Children's Sleep Habits Questionnaire
Time Frame
7 weeks post randomization
Title
Discipline problems trial (Trial 2): parent rated total problem score on the Eyberg Child Behavior Inventory
Time Frame
7 weeks post randomization
Title
Sleep and discipline problems trial (Trial 3): parent report on the Children's Sleep Habit Questionnaire (Group 1-sleep treatment) and parent rated total problem score on the Eyberg Child Behavior Inventory (Group 2-discipline treatment)
Time Frame
7 weeks post randomization
Secondary Outcome Measure Information:
Title
Parenting practices-total score on the Parenting Scale
Time Frame
7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Title
General child behavior problems-total problem score on the Child Behavior Checklist
Time Frame
7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Title
Daily recall ratings of sleep and discipline problems (3 reports in total)
Time Frame
4 & 6 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only
Title
Parent report on the Richman sleep questionnaires (only for Trial 1-sleep and bedtime problems and for Trial 3 participants if in sleep treatment condition)
Time Frame
7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Parent (primary caregiver) of a 2-5 year old child Attending a medical appointment at a family medical practice Phone in home Parent concerned about child's sleep and/or discipline Parent interested in participating in a treatment study Exclusion Criteria: Parent non-English speaking Child with significant physical or developmental disability Parent's only sleep concern is in regards to a physiological sleep disorder (e.g. sleep apnea, snoring) or bedwetting No phone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Graham J Reid, PhD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5A2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22948337
Citation
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 Feb;30(1):14-24. doi: 10.1093/fampra/cms051. Epub 2012 Sep 3.
Results Reference
derived
Links:
URL
http://psychology.uwo.ca/faculty/reid_res.htm
Description
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