Pilot Study of the Vermont Family Based Approach in Primary Care Pediatrics
- Conditions
- Psychiatric Disorder
- Interventions
- Other: Treatment as UsualOther: Vermont Family Based Approach
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Families with a 3 - 15 year-old child who receives his/her primary care at the University of Vermont Pediatric Primary Care Clinic
- 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
- Arm && Interventions
Group Intervention Description Control Treatment as Usual The Control Group received pediatric care as usual. Vermont Family Based Approach 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.
- 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 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)
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)
Trial Locations
- Locations (1)
Vermont Center for Children, Youth & Families
🇺🇸Burlington, Vermont, United States