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A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems

Primary Purpose

Emotional Problems, Behavior Problems

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Family Check Up
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emotional Problems focused on measuring preschool mental health, emotional and behaviour problems

Eligibility Criteria

2 Years - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Family Check Up

Community Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Primary Outcome- Change in Child Externalizing Behaviors
Change in Child Behavior Checklist (CBCL) scores

Secondary Outcome Measures

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

Full Information

First Posted
June 3, 2016
Last Updated
August 31, 2020
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation, Arizona State University, University of Calgary, Simon Fraser University
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1. Study Identification

Unique Protocol Identification Number
NCT02800603
Brief Title
A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems
Official Title
"Making the Race Fair for Young Children at Risk": A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 18, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation, Arizona State University, University of Calgary, Simon Fraser University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Problems, Behavior Problems
Keywords
preschool mental health, emotional and behaviour problems

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Check Up
Arm Type
Experimental
Arm Description
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.
Arm Title
Community Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Family Check Up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Primary Outcome- Change in Child Externalizing Behaviors
Description
Change in Child Behavior Checklist (CBCL) scores
Time Frame
Primary outcome will be measured at baseline, 6- and 12-months after enrollment
Secondary Outcome Measure Information:
Title
Secondary Outcome - Change in Parental Mental Health
Description
The Kessler-6 (K6) will be used to measure change in psychological distress over time
Time Frame
This will be measured at baseline, 6- and 12-months
Title
Secondary Outcome - Change in Parental Stress
Description
Parenting Daily Hassles will be used to measure changes in parental stress over time
Time Frame
This will be measured at baseline and 12-months
Title
Secondary Outcome - Change in Positive Parenting Practice
Description
Positive parenting practice will be coded from videotaped parent-child interactions - outcome is change in positive parenting practice over time
Time Frame
This will be measured at baseline and 12-months
Title
Secondary Outcome - Change in Child Compliance
Description
The Coder Impressions Inventory (COIMP) will be used to score the child's behaviour from videotaped interactions - outcome is change in behaviour over time
Time Frame
This will be measured at baseline and 12-months
Other Pre-specified Outcome Measures:
Title
Exploratory outcome - Health Service Utilization
Description
Service utilization questionnaire
Time Frame
This will be measured at baseline, 3-, 6-, 9- and 12- months.
Title
Exploratory outcome - Change in Behavioural Observations of Parenting
Description
Behavioural Observations of Parenting will be assessed using videotapes of structured interaction between the child and parent
Time Frame
This will be measured at baseline, 6-months and 12 months.
Title
Exploratory outcome - Change in Parental Emotional Regulation
Description
Difficulties in Emotion Regulation Scale (DERS)
Time Frame
Exploratory outcomes will be measured at baseline and at 12 months.
Title
Exploratory outcome - Change in Child Emotional Regulation
Description
Child emotional regulation will be assessed using videotapes of the child performing structured tasks
Time Frame
This will be measured at baseline and at 12 months.
Title
Exploratory outcome -Parent Executive Functioning
Description
Parent executive functioning will be assessed using observation of structured tasks
Time Frame
This will be measured at baseline.
Title
Exploratory outcome - Change in Child Executive Functioning
Description
Child executive functioning will be assessed using observation of structured tasks
Time Frame
This will be measured at baseline and at 12 months.
Title
Exploratory outcome - Change in Hair Cortisol
Description
Small amounts of hair will be collected from child and parents to assess hair cortisol
Time Frame
This will be measured at baseline, 6-months and 12 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Screening eligibility criteria include: Custodial caregivers of a child aged 2 years, 0 months to 4 years, 11 months. 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). Caregivers with sufficient knowledge of English needed for assessment measures Caregivers capable of giving informed, written consent Exclusion Criteria: Children with suspected severe to profound developmental delay Current enrolment in another clinical intervention trial 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa Bennett, MD/PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4L8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems

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