Clinical trial NCT04412590: Pilot Study of the Vermont Family Based Approach in Primary Care Pediatrics
Official title: Pilot Study of the Vermont Family Based Approach in Primary Care Pediatrics at the University of Vermont Medical Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychiatric Disorder
Keywords: Health Promotion
Prevention
Mental health
Quality of life
Pediatrics
Wellness
Preventive Medicine
Preventive Psychiatry
Patient Participation
Health Literacy
Patient Activation
Patient Engagement
Emotional Health
Behavioral Health
Lead sponsor: University of Vermont Medical Center
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility Index 1
timeFrame: during study enrollment
measure: Feasibility Index 2
timeFrame: during study enrollment
measure: Feasibility Index 3
timeFrame: during study enrollment
Secondary outcomes:
measure: Children's Emotional and Behavioral Problems
timeFrame: Baseline, 12 month assessment (final assessment)
measure: Children's Health Related Quality of Life
timeFrame: Baseline, 12 month assessment (final assessment)
measure: Parents' Emotional and Behavioral Problems
timeFrame: Baseline, 12 month assessment (final assessment)
measure: Health Related Quality of Life of Caregivers
timeFrame: Baseline, 12 month assessment (final assessment)
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Vermont Center for Children, Youth & Families
state: Vermont
Study officials:
affiliation: University of Vermont Medical Center
name: James J Hudziak, MD
role: PRINCIPAL_INVESTIGATOR
References:
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