A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems

NCT02800603 | Completed DMC

• 1 other identifier: FCU
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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).

Conditions

Emotional Problems; Behavior Problems

Keywords

preschool mental health; emotional and behaviour problems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Secondary Outcome - Change in Parental Mental Health

  This will be measured at baseline, 6- and 12-months

• Secondary Outcome - Change in Parental Stress

  This will be measured at baseline and 12-months

• Secondary Outcome - Change in Positive Parenting Practice

  This will be measured at baseline and 12-months

• Secondary Outcome - Change in Child Compliance

  This will be measured at baseline and 12-months

Other Outcomes (7)

• Exploratory outcome - Health Service Utilization

  This will be measured at baseline, 3-, 6-, 9- and 12- months.

• Exploratory outcome - Change in Behavioural Observations of Parenting

  This will be measured at baseline, 6-months and 12 months.

• Exploratory outcome - Change in Parental Emotional Regulation

  Exploratory outcomes will be measured at baseline and at 12 months.

Study Arms (2)

Family Check Up

EXPERIMENTAL

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

Community Control

NO INTERVENTION

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.

Interventions

Family Check Up BEHAVIORAL

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.

Family Check Up

Eligibility Criteria

• Age: 2 Years - 4 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator
• Arizona State University: collaborator
• University of Calgary: collaborator
• Simon Fraser University: collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

Location

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MeSH Terms

Conditions

Mental Disorders

Study Officials

• Teresa Bennett, MD/PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 15, 2016
• Study Start: August 18, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)