Clinical Trial: A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: "Making the Race Fair for Young Children at Risk": A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems

Brief Summary: The purpose of the study is to evaluate the first Canadian implementation project of the Family Check up (FCU), an evidence-based prevention and early intervention model that engages families and communities in reducing the burden of childhood emotional and behaviour problems (EBP).

Detailed Summary:

The aim of this study is to establish and evaluate the first Canadian implementation project of the FCU as an evidence-based prevention and early intervention model that engages families and communities in reducing the burden of childhood EBP. These objectives will be achieved in two foundational phases. During Phase 1, the clinical and systems infrastructure required to deliver, sustain and ultimately scale up the FCU will be built. During Phase 2, a 1:1 randomized controlled trial (RCT) will be conducted. The RCT will involve 280 participating caregiver-child dyads to examine the effects of the FCU as a targeted prevention intervention within the Canadian context, as delivered to caregivers and children aged 2-4 years at high risk of persistent childhood EBP.

Phase 1 (June 2016 to December 2016): Training, and Implementation: The REACH Institute at Arizona State University has developed an efficient model for international implementation of the FCU. They will help implement the intervention within McMaster Children's Hospital (MCH), train MCH therapists as FCU consultants, and two trainers. All therapists will be credentialed as FCU consultants by REACH through a process of supervision, consultation and monitoring of therapeutic fidelity.

Phase 2: Investigators will conduct a 1:1 randomized controlled trial of 280 children aged 2-4 years into either the FCU (n=140) or community control (CC, n=140). All 280 participants will undergo screening and a baseline FCU assessment before randomization. Once randomized, the FCU group will be provided with a feedback visit and up to 6 optional sessions of the Everyday Parenting (EDP) curriculum over 16 weeks. The CC group will receive general information about currently available community services in Hamilton. At 6 months, both groups will undergo light assessments. At 12 months bo
Sponsor: McMaster University

Current Primary Outcome:

• Primary Outcome- Change in Child Externalizing Behaviors [ Time Frame: Primary outcome will be measured at baseline, 6- and 12-months after enrollment ]
  Change in Child Behavior Checklist (CBCL) scores
• Primary Outcome - Change in Child Noncompliance With Primary Caregiver [ Time Frame: Primary outcome will be measured at baseline, 6- and 12-months after enrollment ]
  The Coder Impressions Inventory (COIMP) will be used to score the child's behaviour from videotaped interactions - outcome is change in behaviour over time

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Secondary Outcome - Change in Parental Mental Health [ Time Frame: Secondary outcomes will be measured at screening, baseline, 6- and 12-months ]
  Centre for Epidemiologic Studies Depression Scale Revised (CES-D) will be used to measure change in depressive symptomatology over time
• Secondary Outcome - Change in Parental Stress [ Time Frame: Secondary outcomes will be measured at screening, baseline, 6- and 12-months ]
  Parenting Stress Index (PSI) will be used to measure changes in parental stress over time
• Secondary Outcome - Change in Positive Parenting Practice [ Time Frame: Secondary outcomes will be measured at screening, baseline, 6- and 12-months ]
  Positive parenting practice will be coded from videotaped parent-child interactions - outcome is change in positive parenting practice over time

Original Secondary Outcome: Same as current

Information By: McMaster University

Dates:
Date Received: June 3, 2016
Date Started: June 2016
Date Completion: March 2019
Last Updated: June 14, 2016
Last Verified: June 2016