Clinical trial NCT02800603: 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
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Problems
Behavior Problems
Keywords: preschool mental health
emotional and behaviour problems
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
name: Arizona State University
name: University of Calgary
name: Simon Fraser University
First posted: 2016-06-15
Enrollment: 207
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Outcome- Change in Child Externalizing Behaviors
timeFrame: Primary outcome will be measured at baseline, 6- and 12-months after enrollment
Secondary outcomes:
measure: Secondary Outcome - Change in Parental Mental Health
timeFrame: This will be measured at baseline, 6- and 12-months
measure: Secondary Outcome - Change in Parental Stress
timeFrame: This will be measured at baseline and 12-months
measure: Secondary Outcome - Change in Positive Parenting Practice
timeFrame: This will be measured at baseline and 12-months
measure: Secondary Outcome - Change in Child Compliance
timeFrame: This will be measured at baseline and 12-months
Other outcomes:
measure: Exploratory outcome - Health Service Utilization
timeFrame: This will be measured at baseline, 3-, 6-, 9- and 12- months.
measure: Exploratory outcome - Change in Behavioural Observations of Parenting
timeFrame: This will be measured at baseline, 6-months and 12 months.
measure: Exploratory outcome - Change in Parental Emotional Regulation
timeFrame: Exploratory outcomes will be measured at baseline and at 12 months.
measure: Exploratory outcome - Change in Child Emotional Regulation
timeFrame: This will be measured at baseline and at 12 months.
measure: Exploratory outcome -Parent Executive Functioning
timeFrame: This will be measured at baseline.
measure: Exploratory outcome - Change in Child Executive Functioning
timeFrame: This will be measured at baseline and at 12 months.
measure: Exploratory outcome - Change in Hair Cortisol
timeFrame: This will be measured at baseline, 6-months and 12 months.
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Teresa Bennett, MD/PhD
role: PRINCIPAL_INVESTIGATOR
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