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

Psychiatric Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412590
• Other study ID #: CHRMS 16-004
• Status: Completed
• Phase: N/A
• Start date: December 1, 2015
• Est. completion date: June 30, 2018

Study information

• Verified date: May 2020
• Source: University of Vermont Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Problem Behavior
• Psychiatric Disorder

Intervention

Other:
• Vermont Family Based Approach
Comprehensive and individualized program to promote emotional health and wellbeing in families using evidence-based health promotion, prevention and intervention.
• Treatment as Usual
Pediatric care as usual.

Locations

Country	Name	City	State
United States	Vermont Center for Children, Youth & Families	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont Medical Center

Country where clinical trial is conducted

United States, 

References & 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.

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.

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.

Christensen P. The health-promoting family: a conceptual framework for future research. Soc Sci Med. 2004 Jul;59(2):377-87. — View Citation

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. Review. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Index 1	descriptive statistics for the number of family visits with FWCs	during study enrollment
Primary	Feasibility Index 2	descriptive statistics for the number of family visits with FFCs	during study enrollment
Primary	Feasibility Index 3	number of health and wellness supports and services the family engaged with	during study enrollment
Secondary	Children's Emotional and Behavioral Problems	The Child Behavior Checklist (CBCL) Total Problems Score (Range: 0-224; higher scores indicate more emotional and behavioral problems)	Baseline, 12 month assessment (final assessment)
Secondary	Children's Health Related Quality of Life	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)	Baseline, 12 month assessment (final assessment)
Secondary	Parents' Emotional and Behavioral Problems	The Adult Self-Report (ASR) Total Problems Score (Range: 0-224; higher scores indicate higher levels of emotional and behavioral problems)	Baseline, 12 month assessment (final assessment)
Secondary	Health Related Quality of Life of Caregivers	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)	Baseline, 12 month assessment (final assessment)