Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800603
Recruitment Status : Active, not recruiting
First Posted : June 15, 2016
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
Arizona State University
University of Calgary
Simon Fraser University
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE June 3, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date June 19, 2019
Actual Study Start Date  ICMJE August 18, 2017
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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 - Change in Child Noncompliance With Primary Caregiver [ Time Frame: Primary outcome will be measured at baseline, 6- and 12-months after enrollment ]
    The Coder Impressions Inventory (COIMP) will be used to score the child's behaviour from videotaped interactions - outcome is change in behaviour over time
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • Secondary Outcome - Change in Parental Mental Health [ Time Frame: Secondary outcomes will be measured at screening, baseline, 6- and 12-months ]
    Centre for Epidemiologic Studies Depression Scale Revised (CES-D) will be used to measure change in depressive symptomatology over time
  • Secondary Outcome - Change in Parental Stress [ Time Frame: Secondary outcomes will be measured at screening, baseline, 6- and 12-months ]
    Parenting Stress Index (PSI) will be used to measure changes in parental stress over time
  • Secondary Outcome - Change in Positive Parenting Practice [ Time Frame: Secondary outcomes will be measured at screening, baseline, 6- and 12-months ]
    Positive parenting practice will be coded from videotaped parent-child interactions - outcome is change in positive parenting practice over time
Current Other Pre-specified Outcome Measures
 (submitted: March 22, 2018)
  • Exploratory outcome - Health Service Utilization [ Time Frame: This will be measured at baseline, 3-, 6-, 9- and 12- months. ]
    Service utilization questionnaire
  • 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
  • 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 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
  • Exploratory outcome -Parent Executive Functioning [ Time Frame: This will be measured at baseline. ]
    Parent executive functioning will be assessed using observation of structured tasks
  • 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
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: June 14, 2016)
  • Exploratory outcome - Health Service Utilization [ Time Frame: Exploratory outcomes will be measured at baseline and at 12 months. ]
    Service utilization questionnaire
  • Exploratory outcome - Behavioural Observations of Parenting [ Time Frame: Exploratory outcomes will be measured at baseline and at 12 months. ]
    Behavioural Observations of Parenting will be assessed using videotapes of structured interaction between the child and parent
  • Exploratory outcome - Parental Emotional Regulation [ Time Frame: Exploratory outcomes will be measured at baseline and at 12 months. ]
    Difficulties in Emotion Regulation Scale (DERS)
  • Exploratory outcome - Parental Emotional Regulation [ Time Frame: Exploratory outcomes will be measured at baseline and at 12 months. ]
    Emotion Regulation Questionnaire (ERQ)
  • Exploratory outcome - Child Emotional Regulation [ Time Frame: Exploratory outcomes will be measured at baseline and at 12 months. ]
    Child emotional regulation will be assessed using videotapes of the child performing structured tasks
  • Exploratory outcome -Parent Executive Functioning [ Time Frame: Exploratory outcomes will be measured at baseline and at 12 months. ]
    Parent executive functioning will be assessed using observation of structured tasks
  • Exploratory outcome - Child Executive Functioning [ Time Frame: Exploratory outcomes will be measured at baseline and at 12 months. ]
    Child executive functioning will be assessed using observation of structured tasks
  • Exploratory outcome - Hair Cortisol [ Time Frame: Exploratory outcomes will be measured at baseline and at 12 months. ]
    Small amounts of hair will be collected from child and parents to assess hair cortisol
 
Descriptive Information
Brief Title  ICMJE A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems
Official Title  ICMJE "Making the Race Fair for Young Children at Risk": A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Emotional Problems
  • Behavior Problems
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Family Check Up
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 18, 2019)
207
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
280
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 4 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02800603
Other Study ID Numbers  ICMJE FCU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE
  • Hamilton Health Sciences Corporation
  • Arizona State University
  • University of Calgary
  • Simon Fraser University
Investigators  ICMJE
Principal Investigator: Teresa Bennett, MD/PhD McMaster University
PRS Account McMaster University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP