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Completed

NCT Number: NCT04702191

Promoting Healthy Families: A Canadian Evaluation

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.

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Key information

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S3K1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Triple P

Behavioral

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

Circle of Security Parenting

Behavioral

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.

Primary outcomes

  1. Child emotional/behavioural problems

    Time frame: 6-months

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

  2. Parenting Practices

    Time frame: 6-months

    Discipline style measured using the Parenting Scale

Secondary outcomes

  1. Change in Observed Parenting

    Time frame: Baseline, 6-months.

    Video-taped caregiver-child interactions

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PHF

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2021
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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