Promoting Healthy Families: A Canadian Evaluation

Sponsor
McMaster University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04702191
Collaborator
University of Manitoba (Other), Institute for Clinical Evaluative Sciences (Other), Ontario Child Health Support Unit (Other), Public Health Agency of Canada (PHAC) (Other)
600
1
3
58.6
10.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Triple P
  • Behavioral: Circle of Security Parenting
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Promoting Healthy Families: A Canadian Evaluation of Two Evidence-based Parenting Programs
Actual Study Start Date :
Feb 10, 2021
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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.

    Outcome Measures

    Primary Outcome Measures

    1. Child emotional/behavioural problems [6-months]

      The investigators will measure change in child emotional and behavioural problems across time points.

    2. Parenting Practices [6-months]

      Discipline style measured using the Parenting Scale

    Secondary Outcome Measures

    1. Average number of child hospitalizations and injuries [24 months]

      Data for the secondary outcomes will be derived from various ICES databases including Health Services Administrative Data (physician billings, inpatient hospital discharges and emergency and ambulatory care visits).

    2. Change in Observed Parenting [Baseline, 9-weeks, 6- and 12-months.]

      Video-taped caregiver-child interactions

    Other Outcome Measures

    1. Caregiver Emotion Regulation [Baseline, 9-weeks, 6- and 12-months.]

      Change in Parental Emotional Regulation will be measured using the Difficulties in Emotion Regulation Scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 6 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 McMaster University Hamilton Ontario Canada L8S3K1

    Sponsors and Collaborators

    • McMaster University
    • University of Manitoba
    • Institute for Clinical Evaluative Sciences
    • Ontario Child Health Support Unit
    • Public Health Agency of Canada (PHAC)

    Investigators

    • Principal Investigator: Andrea Gonzalez, PhD, McMaster University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Andrea Gonzalez, Associate Professor, McMaster University
    ClinicalTrials.gov Identifier:
    NCT04702191
    Other Study ID Numbers:
    • 10583
    First Posted:
    Jan 8, 2021
    Last Update Posted:
    Mar 3, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 3, 2021