Clinical Trials Directory

Trials / Completed

CompletedNCT04412590

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

Pilot Study of the Vermont Family Based Approach in Primary Care Pediatrics at the University of Vermont Medical Center

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
90 (actual)
Sponsor
University of Vermont Medical Center · Academic / Other
Sex
All
Age
3 Years – 15 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERVermont Family Based ApproachComprehensive and individualized program to promote emotional health and wellbeing in families using evidence-based health promotion, prevention and intervention.
OTHERTreatment as UsualPediatric care as usual.

Timeline

Start date
2015-12-01
Primary completion
2018-06-30
Completion
2018-06-30
First posted
2020-06-02
Last updated
2020-06-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04412590. Inclusion in this directory is not an endorsement.