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Completed

NCT Number: NCT04412590

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

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.

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Key information

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vermont Center for Children, Youth & Families

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vermont Family Based Approach

Other

Comprehensive and individualized program to promote emotional health and wellbeing in families using evidence-based health promotion, prevention and intervention.

Other names: VFBA

Treatment as Usual

Other

Pediatric care as usual.

Other names: TAU

Primary outcomes

  1. Feasibility Index 1

    Time frame: during study enrollment

    descriptive statistics for the number of family visits with FWCs

  2. Feasibility Index 2

    Time frame: during study enrollment

    descriptive statistics for the number of family visits with FFCs

  3. Feasibility Index 3

    Time frame: during study enrollment

    number of health and wellness supports and services the family engaged with

Secondary outcomes

  1. Children's Emotional and Behavioral Problems

    Time frame: 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)

  2. Children's Health Related Quality of Life

    Time frame: 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)

  3. Parents' Emotional and Behavioral Problems

    Time frame: 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)

  4. Health Related Quality of Life of Caregivers

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Vermont Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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