Pilot Study of the Vermont Family Based Approach in Primary Care Pediatrics

Not Applicable

Completed

• Conditions: Psychiatric Disorder

• Registration Number: NCT04412590
• Lead Sponsor: University of Vermont Medical Center

Brief Summary

This pilot randomized controlled trial of the Vermont Family Based Approach (VFBA) tested the feasibility of the VFBA in primary care pediatrics and its effects on children's and parents' emotional and behavioral problems and health-related quality of life. The VFBA is a public health framework for evidence-based health promotion, prevention, and treatment that is delivered from the family perspective and emphasizes emotional and behavioral health. The VFBA group received the VFBA intervention, while the Control group received pediatric primary care as usual.

Detailed Description

To enhance the health of our communities, we need approaches to healthcare delivery that focus on the entire family, recognize the central role of emotional and behavioral health in relation to all health, use evidence-based health promotion in addition to evidence based treatment of existing problems, and intervene early in children's life.

The VFBA is a public health framework for evidence-based health promotion, prevention, and treatment that is delivered from the family perspective and emphasizes emotional and behavioral health.

The study was a pilot RCT of the VFBA in a primary care pediatrics clinic. The goals of the study were to test whether the VFBA would (1) be feasible in primary care pediatrics and (2) would lead to improved emotional and behavioral health and health-related quality of life or children and parents. Families were recruited at the pediatric clinic and randomized to the VFBA or Control conditions.

The VFBA group received family-based assessment of emotional and behavioral health and family functioning, family wellness coaching, and a menu of cost-free wellness activities, such as parent and child violin instruction, yoga and mindfulness training, and nutrition counseling. Where indicated by results of family-based assessment, families in the VFBA group also received family-based, evidence-based psychotherapy and psychiatric care. Families in the Control group received pediatric primary care, as usual.

Study Timeline

• Study First Submitted: 2015-09-09
• Study Start: 2015-12-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-31
• Last Update Submitted: 2020-05-31
• Study First Posted: 2020-06-02
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Families with a 3 - 15 year-old child who receives his/her primary care at the University of Vermont Pediatric Primary Care Clinic

Exclusion Criteria

• Families with a target child in the legal custody of the State of Vermont
• Families where the parents' proficiency in English is not sufficient to participate in the protocol without an interpreter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility Index 2	during study enrollment	descriptive statistics for the number of family visits with FFCs
Feasibility Index 3	during study enrollment	number of health and wellness supports and services the family engaged with
Feasibility Index 1	during study enrollment	descriptive statistics for the number of family visits with FWCs

Secondary Outcome Measures

Name	Time	Method
Parents' Emotional and Behavioral Problems	Baseline, 12 month assessment (final assessment)	The Adult Self-Report (ASR) Total Problems Score (Range: 0-224; higher scores indicate higher levels of emotional and behavioral problems)
Health Related Quality of Life of Caregivers	Baseline, 12 month assessment (final assessment)	The MOS 36-item Short-Form Health Survey (MOS-36) General Health Scale (Range: 0-100; higher scores indicate higher health-related quality of life)
Children's Health Related Quality of Life	Baseline, 12 month assessment (final assessment)	The Child Health Questionnaire for Parents - Short Form (CHQ-SF) General Health Perceptions (Range: 0-100; higher scores indicate greater health-related quality of life)
Children's Emotional and Behavioral Problems	Baseline, 12 month assessment (final assessment)	The Child Behavior Checklist (CBCL) Total Problems Score (Range: 0-224; higher scores indicate more emotional and behavioral problems)

Trial Locations

Locations (1)

Vermont Center for Children, Youth & Families; 🇺🇸 Burlington, Vermont, United States