Pilot Study of the Vermont Family Based Approach in Primary Care Pediatrics at the University of Vermont Medical Center
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Feasibility Index 1
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 3 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Vermont Family Based Approach
The VFBA group was offered a variety of supports and services to help them achieve and maintain wellness and address emotional behavioral challenges.
All families partnered with a Family Wellness Coach (FWC) to design and implement a comprehensive program of family health and wellness with an emphasis on nutrition, exercise, music training, mindfulness, decreasing screen time, and positive parenting.
Families with a child or parent experiencing significant emotional and behavioral problems were also partnered with Focused Family Coaches (FFCs) and Family Based Psychiatrists (FBPs). FFCs and FBPs respectively provided evidence-based psychotherapy and psychiatric care from the family perspective.
Families also were also offered health promotion programs, including music lessons for all family members, behavioral parent training, yoga and mindfulness training, and nutrition coaching.
Intervention: Vermont Family Based Approach (Other)
Control
The Control Group received pediatric care as usual.
Intervention: Treatment as Usual (Other)
Outcomes
Primary Outcomes
Feasibility Index 1
Time Frame: during study enrollment
descriptive statistics for the number of family visits with FWCs
Feasibility Index 2
Time Frame: during study enrollment
descriptive statistics for the number of family visits with FFCs
Feasibility Index 3
Time Frame: during study enrollment
number of health and wellness supports and services the family engaged with
Secondary Outcomes
- Parents' Emotional and Behavioral Problems(Baseline, 12 month assessment (final assessment))
- Health Related Quality of Life of Caregivers(Baseline, 12 month assessment (final assessment))
- Children's Health Related Quality of Life(Baseline, 12 month assessment (final assessment))
- Children's Emotional and Behavioral Problems(Baseline, 12 month assessment (final assessment))
Investigators
James Hudziak
Professor of Psychiatry, Medicine, Pediatrics, and Communication Sciences & Disorders; Director of the Vermont Center for Children, Youth & Families
University of Vermont Medical Center