A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Emotional Problems, Behavior Problems

Intervention / Treatment
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* Behavioral: Family Check Up


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family Check Up<br>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<br>* 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.<br>|
| No Intervention: Community Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome- Change in Child Externalizing Behaviors | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preschool mental health, emotional and behaviour problems