A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems

Behavior Problems Clinical Trial

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

Status Completed

Clinical Trial 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).

Clinical Trial Description

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: 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 both groups will repeat the baseline assessment, and the FCU group will have 1-2 FCU visits. ;

Related Conditions & MeSH terms

• Behavior Problems
• Emotional Problems
• Problem Behavior

• NCT number: NCT02800603
• Study type: Interventional
• Source: McMaster University
• Status: Completed
• Phase: N/A
• Start date: August 18, 2017
• Completion date: June 30, 2020