A Targeted Prevention Approach to Reducing Child Emotional and Behaviour Problems

Behavior Problems Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800603
• Other study ID #: FCU
• Status: Completed
• Phase: N/A
• Start date: August 18, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior Problems
• Emotional Problems
• Problem Behavior

Intervention

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.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (5)

Lead Sponsor	Collaborator
McMaster University	Arizona State University, Hamilton Health Sciences Corporation, Simon Fraser University, University of Calgary

Country where clinical trial is conducted

Canada, 

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome - Health Service Utilization	Service utilization questionnaire	This will be measured at baseline, 3-, 6-, 9- and 12- months.
Other	Exploratory outcome - Change in Behavioural Observations of Parenting	Behavioural Observations of Parenting will be assessed using videotapes of structured interaction between the child and parent	This will be measured at baseline, 6-months and 12 months.
Other	Exploratory outcome - Change in Parental Emotional Regulation	Difficulties in Emotion Regulation Scale (DERS)	Exploratory outcomes will be measured at baseline and at 12 months.
Other	Exploratory outcome - Change in Child Emotional Regulation	Child emotional regulation will be assessed using videotapes of the child performing structured tasks	This will be measured at baseline and at 12 months.
Other	Exploratory outcome -Parent Executive Functioning	Parent executive functioning will be assessed using observation of structured tasks	This will be measured at baseline.
Other	Exploratory outcome - Change in Child Executive Functioning	Child executive functioning will be assessed using observation of structured tasks	This will be measured at baseline and at 12 months.
Other	Exploratory outcome - Change in Hair Cortisol	Small amounts of hair will be collected from child and parents to assess hair cortisol	This will be measured at baseline, 6-months and 12 months.
Primary	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	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	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	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	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