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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psychiatric Disorder

Intervention / Treatment
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* Other: Vermont Family Based Approach
* Other: Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vermont Family Based Approach<br>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<br>* Comprehensive and individualized program to promote emotional health and wellbeing in families using evidence-based health promotion, prevention and intervention.<br>* Other names: VFBA;|
| Active Comparator: Control<br>The Control Group received pediatric care as usual. | Other: Treatment as Usual<br>* Pediatric care as usual.<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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