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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 : Completed
First Posted : June 15, 2016
Last Update Posted : September 2, 2020
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
Arizona State University
University of Calgary
Simon Fraser University
Information provided by (Responsible Party):
McMaster University

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).

Condition or disease Intervention/treatment Phase
Emotional Problems Behavior Problems Behavioral: Family Check Up Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: "Making the Race Fair for Young Children at Risk": A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems
Actual Study Start Date : August 18, 2017
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : June 30, 2020

Arm Intervention/treatment
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.
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.

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Other Outcome Measures:
  1. Exploratory outcome - Health Service Utilization [ Time Frame: This will be measured at baseline, 3-, 6-, 9- and 12- months. ]
    Service utilization questionnaire

  2. 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

  3. 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)

  4. 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

  5. Exploratory outcome -Parent Executive Functioning [ Time Frame: This will be measured at baseline. ]
    Parent executive functioning will be assessed using observation of structured tasks

  6. 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

  7. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800603


Locations
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Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L8S 4L8
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Arizona State University
University of Calgary
Simon Fraser University
Investigators
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Principal Investigator: Teresa Bennett, MD/PhD McMaster University
Publications:
Radloff, L. S. The CES-D scale: A self-report depression scale for research in the general population. Applied psychological measurement 1(3): 385-401, 1977.
Eaton WW, Muntaner C, Smith C, Tien A, Ybarra M. The Use of Psychological Testing for Treatment Planning and Outcomes Assessment, Volume 3: Instruments for Adults, 3rd ed. Mahwah, NJ: Lawrence Erlbaum; 2004. Chapter 11, Center for Epidemiologic Studies Depression Scale: Review and revision (CESD and CESD-R); p 363-377.
Gratz, K.L., & Roemer, L. Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment 26(1): 41-54, 2004.

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02800603    
Other Study ID Numbers: FCU
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
preschool mental health
emotional and behaviour problems
Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms