Clinical trial NCT04702191: Promoting Healthy Families: A Canadian Evaluation
Official title: Promoting Healthy Families: A Canadian Evaluation of Two Evidence-based Parenting Programs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Behavior Problem
Parenting
Keywords: child behavior problem, parenting, parental capacity
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: University of Manitoba
name: Institute for Clinical Evaluative Sciences
name: Public Health Agency of Canada (PHAC)
name: University of Exeter
First posted: 2021-01-08
Enrollment: 502
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Child emotional/behavioural problems
timeFrame: 6-months
measure: Parenting Practices
timeFrame: 6-months
Secondary outcomes:
measure: Change in Observed Parenting
timeFrame: Baseline, 6-months.
Other outcomes:
measure: Caregiver Emotion Regulation
timeFrame: Baseline, 6- and 12-months.
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Andrea Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnold, D.S., O'Leary, S.G., Wolff, L.S., & Acker, M.M. (1993). The Parenting Scale: A Measure of Dysfunctional Parenting in Discipline Situations. Psychological Assessment, 5(2), 137-144.
citation: Cooper, G., Hoffman, K., Powell, B., & Marvin, R. (2005). The circle of security intervention: Differential diagnosis and differential treatment. In L. J. Berlin, Y. Ziv, L. Amaya-Jackson, & M. T. Greenberg (Eds.), Enhancing early attachments: Theory, research, intervention, and policy (pp. 127-151). New York, NY: The Guilford Press.
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