Promoting Healthy Families: A Canadian Evaluation (PHF)

December 3, 2024 updated by: Andrea Gonzalez (for Nathan), McMaster University

Promoting Healthy Families: A Canadian Evaluation of Two Evidence-based Parenting Programs

Interventions that promote safe, stable, and nurturing relationships between caregivers and children are key to improving healthy family relationships, reducing child socioemotional and behaviour problems, and preventing child maltreatment. Although a broad range of parenting programs are currently implemented in communities across Ontario, most programs are inadequately evaluated, or else not evaluated at all. Using a three-armed randomized controlled trial, the aim of the current study is to evaluate the effectiveness of two parenting programs, the Triple P - Positive Parenting Program (group - level 4) and the Circle of Security Parenting Program (group) compared to treatment as usual in Ontario, Canada.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The overall goal of the evaluation is to provide robust evidence about the implementation and effectiveness of two parenting programs, the Triple P and Circle of Security Parenting (COSP), in the province of Ontario, on parenting practices and functioning, and child emotional behaviour problems outcomes, and secondary outcomes including selected child maltreatment-related outcomes. These objectives will be achieved in two phases. The investigators will conduct a multi-site, three-arm randomized controlled trial of 600 participating caregivers and their children to compare Triple P (level 4 group) and COSP to treatment as usual (TAU) with respect to improving positive practices and child outcomes. Participants will be randomly assigned to one of the three conditions using stratified (by site) block randomization. All participants will undergo screening and a baseline assessment before randomization. Once randomized, the Triple P and COSP caregivers will receive 8-week session. The TAU group will receive a different program, or short therapy sessions depending on the organization. Caregivers will complete follow-up assessments at post-treatment, 6- and 12-months.

Study Type

Interventional

Enrollment (Actual)

502

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S3K1
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Caregivers of children are eligible for inclusion if:

  • Custodial caregiver of child is aged 2 to 6 years at time of screening.
  • Families with sufficient knowledge of English needed for assessment measures.
  • Caregivers capable of giving informed, written consent.

  • Definition of 'at-risk' as measured by one of the following criteria as outlined below:

    • Elevated child emotional behavioural problems as indexed by above- population mean total scores on the Strengths and Difficulties Questionnaire (SDQ); OR
    • One of the following family or contextual risk factor
    • Parental challenge - parental mental health problems, as indexed by score on K6 distress scale ≥ 13; adolescent parent status (less than 20 years of age); single parent status; OR Sociodemographic risk factor - parent with less than grade 12 education; parent on social assistance;
    • Expressed difficulties with parenting: Do you often feel like your child is difficult to take care of?

Exclusion Criteria:

• Children with suspected severe to profound developmental delay.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Triple P (Positive Parenting Program)
Triple P - level 4 group: All 600 participants will undergo screening and a baseline assessment before randomization. Once randomized, the Triple P group (n=200) will be provided with 8-week group/individual sessions.
Behavioral: Triple P
Triple P - level 4 group is a group-based parenting intervention for families with children who exhibit behavioural or emotional difficulties. Group sessions typically focus on topics such as positive parenting, helping children develop, managing misbehaviour, and planning ahead. Practitioners then provide individual feedback on progress using positive parenting strategies and goal setting. Trained practitioners will deliver the program according to the manualized protocol (Turner, Markie-Dadds, & Sanders, 2010). This will include eight weekly sessions with maximum of 12 parents. The first four sessions will be as group sessions. These four group sessions will be followed by three one-to-one practical and personalised telephone consultations. Finally, there will be one group session, which will complete the programme and parents' contact with the Triple P practitioners. The main aim of this session is to review progress and plan for the future.
Other Names:
  • Triple P - group level 4
Experimental: Circle of Security Parenting
Circle of Security - Parenting (COS-P): Once randomized to the COSP group (n=200), caregivers will be provided with an 8-week group session.
Behavioral: Circle of Security Parenting
Circle of Security - Parenting (COS-P) will be delivered according to the protocol outlined by Cooper, Hoffman and Powell (Cooper et al., 2009). COS-P is a manualized eight-session parent-education group program which has the same broad aims and core components of the COS-Intensive model from which it was developed (i.e., to increase caregiver sensitivity and responsiveness to child cues, empathy for the child by supporting parental reflective functioning, recognition and understanding of child attachment cues, and awareness of the impact of the caregiver's own attachment history on caregiving patterns). The program is led by one or two facilitators and includes 10-12 caregivers. The program uses clinical DVD clips of problematic parent-child interaction and healthy alternatives to illustrate attachment patterns and parenting styles, and to promote group discussion.
No Intervention: Treatment As Usual
Treatment as usual: Caregivers randomized to this arm (n=200) will receive either a different program, or brief services depending on the organization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child emotional/behavioural problems
Time Frame: 6-months
The investigators will measure change in child emotional and behavioural problems across time points.
6-months
Parenting Practices
Time Frame: 6-months
Discipline style measured using the Parenting Scale
6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Observed Parenting
Time Frame: Baseline, 6-months.
Video-taped caregiver-child interactions
Baseline, 6-months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Emotion Regulation
Time Frame: Baseline, 6- and 12-months.
Change in Parental Emotional Regulation will be measured using the Difficulties in Emotion Regulation Scale.
Baseline, 6- and 12-months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

University of Manitoba
Institute for Clinical Evaluative Sciences
University of Exeter
Public Health Agency of Canada (PHAC)

Investigators

  • Principal Investigator: Andrea Gonzalez, PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Actual)

March 15, 2024

Study Completion (Actual)

March 17, 2024

Study Registration Dates

First Submitted

January 2, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Actual)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10583 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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