School and Family Problems of Children With Kidney Failure |
|
|
Clinical Trial: Parenting Matters: Helping Parents with Young Children
This study is currently recruiting patients.
Verified by University of Western Ontario, Canada August 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Sleep Problems Behavior Problems Psychosocial | Behavior: Self-help treatment booklet and telephone support Behavior: Usual care by a family physician | Phase II |
MedlinePlus related topics: Sleep Disorders
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Secondary Outcomes: 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 (3 reports in total); 4. 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)
Expected Total Enrollment: 480
Study start: July 2005; Expected completion: December 2008
Last follow-up: January 2008; Data entry closure: February 2008
About 1 in 5 young children (age 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. 1) 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.
1b) 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.
2) Test the efficacy of the Parenting Matters program in improving parenting practices.
3) Test the efficacy of the Parenting Matters program in reducing child behaviour problems in general.
4) 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: (a) reach the largest number of individuals in need, are (b) cost effective, and (c) 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.
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria: (1) parent (primary caregiver) of a 2-5 year old child; (2) attending a medical appointment at a family medical practice; (3) phone in home; (4) parent concerned about child''''s sleep and/or discipline; (5) parent interested in participating in a treatment study
Exclusion Criteria: (1) parent non-English speaking; (2) child with significant physical or developmental disability; (3) parent''''s only sleep concern is in regards to a physiological sleep disorder (e.g. sleep apnea, snoring) or bedwetting (4) no phone
Location and Contact Information
Canada, Ontario
University of Western Ontario, London, Ontario, N6C 5A2, Canada; Recruiting
Moira Steward, PhD, Sub-Investigator
Evelyn Vingilis, PhD, Sub-Investigator
David Dozois, Phd, Sub-Investigator
David Pederson, Phd, Sub-Investigator
Steve Wetmore, MD, Sub-Investigator
Gordon Dickie, MD, Sub-Investigator
John Jordan, MD, Sub-Investigator
Ted Osmun, MD, Sub-Investigator
Terry Wade, PhD, Sub-Investigator
Judith Brown, PhD, Sub-Investigator
Graham J Reid, PhD, Principal Investigator, University of Western Ontario, Canada
More Information
Last Updated: August 19, 2005
Record first received: August 18, 2005
ClinicalTrials.gov Identifier: NCT00133055
Health Authority: Canada: Health Canada
ClinicalTrials.gov processed this record on 2005-08-23

Not Signed In -


