跳至主要内容
临床试验/NCT04412590
NCT04412590已完成不适用

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

University of Vermont Medical Center2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Feasibility Index 1

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
3 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Feasibility Index 1

时间窗: during study enrollment

descriptive statistics for the number of family visits with FWCs

Feasibility Index 2

时间窗: during study enrollment

descriptive statistics for the number of family visits with FFCs

Feasibility Index 3

时间窗: during study enrollment

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

次要结局

  • Parents' Emotional and Behavioral Problems(Baseline, 12 month assessment (final assessment))
  • Health Related Quality of Life of Caregivers(Baseline, 12 month assessment (final assessment))
  • Children's Health Related Quality of Life(Baseline, 12 month assessment (final assessment))
  • Children's Emotional and Behavioral Problems(Baseline, 12 month assessment (final assessment))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Hudziak

Professor of Psychiatry, Medicine, Pediatrics, and Communication Sciences & Disorders; Director of the Vermont Center for Children, Youth & Families

University of Vermont Medical Center

研究点 (2)

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