NCT00133055

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
548

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

April 13, 2018

Status Verified

August 1, 2011

Enrollment Period

3.7 years

First QC Date

August 18, 2005

Last Update Submit

April 11, 2018

Conditions

Keywords

parentingsleep problemsbehavior problemsbrief interventionself-helppreschool-age childrenpsychosocial

Outcome Measures

Primary Outcomes (3)

  • Sleep and bedtime problems trial (Trial 1): parent report on the Children's Sleep Habits Questionnaire

    7 weeks post randomization

  • Discipline problems trial (Trial 2): parent rated total problem score on the Eyberg Child Behavior Inventory

    7 weeks post randomization

  • 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)

    7 weeks post randomization

Secondary Outcomes (4)

  • Parenting practices-total score on the Parenting Scale

    7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only

  • General child behavior problems-total problem score on the Child Behavior Checklist

    7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only

  • Daily recall ratings of sleep and discipline problems (3 reports in total)

    4 & 6 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only

  • 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)

    7 weeks post randomization; 3- & 6-month follow-up; 12-month follow-up treatment group only

Study Arms (2)

Treatment booklet and telephone coaching

EXPERIMENTAL
Behavioral: Self-help treatment booklet and telephone support

Usual Care

OTHER
Behavioral: Usual care by a family physician

Interventions

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.

Treatment booklet and telephone coaching

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.

Usual Care

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Western Ontario

London, Ontario, N6C 5A2, Canada

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

ParasomniasMental DisordersChild Behavior

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesBehavior

Study Officials

  • Graham J Reid, PhD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 18, 2005

First Posted

August 22, 2005

Study Start

July 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 13, 2018

Record last verified: 2011-08

Locations