A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems

August 31, 2020 updated by: McMaster University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4L8
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Screening eligibility criteria include:

  1. Custodial caregivers of a child aged 2 years, 0 months to 4 years, 11 months.

  2. Definition of "at-risk" for child EBP as measured by (a) OR (b):

    • Elevated child EBP as indexed by above-population mean total scores on Strengths and Difficulties Questionnaire (SDQ), plus one of the following family or contextual risk factors

      • Caregiver challenges: teen parent status, caregiver mental health problems (as indexed by K6 psychological distress scale), lone caregiver
      • Sociodemographic risk factors (as indexed by the 2014 Ontario Child Health Study (OCHS) demographics questionnaire): family income below low-income cut-off (LICO), caregiver with less than grade 12 education, caregiver on social assistance.
    • Families who score within norms on caregiver or sociodemographic risk AND child SDQ scores fall within the "high" range, indicating significant burden of EBP (and thus increased risk of persistent, severe problems over time).
  3. Caregivers with sufficient knowledge of English needed for assessment measures
  4. Caregivers capable of giving informed, written consent

Exclusion Criteria:

  1. Children with suspected severe to profound developmental delay
  2. Current enrolment in another clinical intervention trial
  3. Caregiver or child with a serious medical condition that, based on Investigator judgment, might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Family Check Up
FCU Intervention: All 280 participants will undergo screening and a baseline FCU assessment before randomization. Once randomized, the FCU group (n=140) will be provided with a feedback visit and up to 6 optional sessions of the EDP curriculum over 16 weeks.
Behavioral: Family Check Up
The FCU is an ecologically sensitive, evidence-based, targeted intervention that aims to reduce child EBP. Features of the FCU: 1) Assessment-driven: a multi-method, multi-informant assessment in which the consultant reviews strengths and difficulties across domains of contextual risk, family functioning and child health. A tailored intervention plan is then created based on results 2) Motivational interviewing: Caregivers engage in self-assessment about motivation and barriers to addressing factors that may perpetuate risk. The consultant and caregiver work to establish a menu of services 3) The family may be offered up to 6 sessions of the "Everyday Parenting" curriculum. The FCU has demonstrated effectiveness and cultural sensitivity across multiple US settings.
No Intervention: Community Control
The Community Control group (n=140) will receive general information that includes a list of all the relevant services available in Hamilton. As such, the community control group would be provided with all the information needed to obtain standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 will be measured at baseline, 6- and 12-months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Outcome - Change in Parental Mental Health
Time Frame: This will be measured at baseline, 6- and 12-months
The Kessler-6 (K6) will be used to measure change in psychological distress over time
This will be measured at baseline, 6- and 12-months
Secondary Outcome - Change in Parental Stress
Time Frame: This will be measured at baseline and 12-months
Parenting Daily Hassles will be used to measure changes in parental stress over time
This will be measured at baseline and 12-months
Secondary Outcome - Change in Positive Parenting Practice
Time Frame: This will be measured at baseline and 12-months
Positive parenting practice will be coded from videotaped parent-child interactions - outcome is change in positive parenting practice over time
This will be measured at baseline and 12-months
Secondary Outcome - Change in Child Compliance
Time Frame: This will be measured at baseline and 12-months
The Coder Impressions Inventory (COIMP) will be used to score the child's behaviour from videotaped interactions - outcome is change in behaviour over time
This will be measured at baseline and 12-months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploratory outcome - Health Service Utilization
Time Frame: This will be measured at baseline, 3-, 6-, 9- and 12- months.
Service utilization questionnaire
This will be measured at baseline, 3-, 6-, 9- and 12- months.
Exploratory outcome - Change in Behavioural Observations of Parenting
Time Frame: This will be measured at baseline, 6-months and 12 months.
Behavioural Observations of Parenting will be assessed using videotapes of structured interaction between the child and parent
This will be measured at baseline, 6-months and 12 months.
Exploratory outcome - Change in Parental Emotional Regulation
Time Frame: Exploratory outcomes will be measured at baseline and at 12 months.
Difficulties in Emotion Regulation Scale (DERS)
Exploratory outcomes will be measured at baseline and at 12 months.
Exploratory outcome - Change in Child Emotional Regulation
Time Frame: This will be measured at baseline and at 12 months.
Child emotional regulation will be assessed using videotapes of the child performing structured tasks
This will be measured at baseline and at 12 months.
Exploratory outcome -Parent Executive Functioning
Time Frame: This will be measured at baseline.
Parent executive functioning will be assessed using observation of structured tasks
This will be measured at baseline.
Exploratory outcome - Change in Child Executive Functioning
Time Frame: This will be measured at baseline and at 12 months.
Child executive functioning will be assessed using observation of structured tasks
This will be measured at baseline and at 12 months.
Exploratory outcome - Change in Hair Cortisol
Time Frame: This will be measured at baseline, 6-months and 12 months.
Small amounts of hair will be collected from child and parents to assess hair cortisol
This will be measured at baseline, 6-months and 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

University of Calgary
Hamilton Health Sciences Corporation
Arizona State University
Simon Fraser University

Investigators

  • Principal Investigator: Teresa Bennett, MD/PhD, McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

June 3, 2016

First Submitted That Met QC Criteria

June 14, 2016

First Posted (Estimate)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FCU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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