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Clinical Trials/NCT04702191
NCT04702191CompletedNot Applicable

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

McMaster University1 site in 1 country502 target enrollmentStarted: February 10, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
502
Locations
1
Primary Endpoint
Parenting Practices

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Years to 6 Years (Child)
Sex
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.

Arms & Interventions

Triple P (Positive Parenting Program)

Experimental

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.

Intervention: Triple P (Behavioral)

Circle of Security Parenting

Experimental

Circle of Security - Parenting (COS-P): Once randomized to the COSP group (n=200), caregivers will be provided with an 8-week group session.

Intervention: Circle of Security Parenting (Behavioral)

Treatment As Usual

No Intervention

Treatment as usual: Caregivers randomized to this arm (n=200) will receive either a different program, or brief services depending on the organization.

Outcomes

Primary Outcomes

Parenting Practices

Time Frame: 6-months

Discipline style measured using the Parenting Scale

Child emotional/behavioural problems

Time Frame: 6-months

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

Secondary Outcomes

  • Change in Observed Parenting(Baseline, 6-months.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrea Gonzalez (for Nathan)

Associate Professor

McMaster University

Study Sites (1)

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