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

NCT04412590 | Completed

• 1 other identifier: CHRMS 16-004
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Feasibility Index 1

  descriptive statistics for the number of family visits with FWCs

  during study enrollment

• Feasibility Index 2

  descriptive statistics for the number of family visits with FFCs

  during study enrollment

• Feasibility Index 3

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

  during study enrollment

Secondary Outcomes (4)

• Children's Emotional and Behavioral Problems

  Baseline, 12 month assessment (final assessment)

• Children's Health Related Quality of Life

  Baseline, 12 month assessment (final assessment)

• Parents' Emotional and Behavioral Problems

  Baseline, 12 month assessment (final assessment)

• Health Related Quality of Life of Caregivers

  Baseline, 12 month assessment (final assessment)

Study Arms (2)

Vermont Family Based Approach

EXPERIMENTAL

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.

Other: Vermont Family Based Approach

Control

ACTIVE COMPARATOR

The Control Group received pediatric care as usual.

Other: Treatment as Usual

Interventions

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.

Also known as: VFBA

Vermont Family Based Approach

Treatment as Usual OTHER

Pediatric care as usual.

Also known as: TAU

Control

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Families with a 3 - 15 year-old child who receives his/her primary care at the University of Vermont Pediatric Primary Care Clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont Medical Center: lead

Study Sites (1)

Vermont Center for Children, Youth & Families

Burlington, Vermont, 05401, United States

Location

Related Publications (10)

• Achenbach, T. M., & Rescorla, L. A. (2003). Manual for the ASEBA Adult Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, & Families.

  BACKGROUND

• Achenbach, T.M., & Rescorla, L.A. (2003). Manual for the ASEBA School-Age Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth & Families.

  BACKGROUND

• Achenbach, T.M., & Rescorla, L.A. (2000). Manual for the ASEBA Preschool Forms & Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, and Families.

  BACKGROUND

• Christensen P. The health-promoting family: a conceptual framework for future research. Soc Sci Med. 2004 Jul;59(2):377-87. doi: 10.1016/j.socscimed.2003.10.021.

  PMID: 15110427 BACKGROUND

• Hudziak, J.J., & Bartels, M. (2008). Genetic and environmental influences on wellness, resilience, and psychopathology: A family-based approach for promotion, prevention, and intervention. In J.J. Hudziak (Ed.), Developmental psychopathology and wellness: Genetic and environmental influences. (pp. 267-286). New York, NY: American Psychopathological Association.

  BACKGROUND

• McHorney CA, Ware JE Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993 Mar;31(3):247-63. doi: 10.1097/00005650-199303000-00006.

  PMID: 8450681 BACKGROUND

• McHorney CA, Ware JE Jr, Lu JF, Sherbourne CD. The MOS 36-item Short-Form Health Survey (SF-36): III. Tests of data quality, scaling assumptions, and reliability across diverse patient groups. Med Care. 1994 Jan;32(1):40-66. doi: 10.1097/00005650-199401000-00004.

  PMID: 8277801 BACKGROUND

• Raat H, Botterweck AM, Landgraf JM, Hoogeveen WC, Essink-Bot ML. Reliability and validity of the short form of the child health questionnaire for parents (CHQ-PF28) in large random school based and general population samples. J Epidemiol Community Health. 2005 Jan;59(1):75-82. doi: 10.1136/jech.2003.012914.

  PMID: 15598731 BACKGROUND

• Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

  PMID: 1593914 BACKGROUND

• Hudziak J, Ivanova MY. The Vermont Family Based Approach: Family Based Health Promotion, Illness Prevention, and Intervention. Child Adolesc Psychiatr Clin N Am. 2016 Apr;25(2):167-78. doi: 10.1016/j.chc.2015.11.002. Epub 2016 Jan 19.

  PMID: 26980122 BACKGROUND

MeSH Terms

Conditions

Mental Disorders; Psychological Well-Being; Patient Participation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Study Officials

• James J Hudziak, MD

  University of Vermont Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry, Medicine, Pediatrics, and Communication Sciences & Disorders; Director of the Vermont Center for Children, Youth & Families

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: June 2, 2020
• Study Start: December 1, 2015
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)