<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04412590</url>
  </required_header>
  <id_info>
    <org_study_id>CHRMS 16-004</org_study_id>
    <nct_id>NCT04412590</nct_id>
  </id_info>
  <brief_title>Pilot Study of the Vermont Family Based Approach in Primary Care Pediatrics</brief_title>
  <official_title>Pilot Study of the Vermont Family Based Approach in Primary Care Pediatrics at the University of Vermont Medical Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Vermont Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot randomized controlled trial of the Vermont Family Based Approach (VFBA) tested the&#xD;
      feasibility of the VFBA in primary care pediatrics and its effects on children's and parents'&#xD;
      emotional and behavioral problems and health-related quality of life. The VFBA is a public&#xD;
      health framework for evidence-based health promotion, prevention, and treatment that is&#xD;
      delivered from the family perspective and emphasizes emotional and behavioral health. The&#xD;
      VFBA group received the VFBA intervention, while the Control group received pediatric primary&#xD;
      care as usual.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To enhance the health of our communities, we need approaches to healthcare delivery that&#xD;
      focus on the entire family, recognize the central role of emotional and behavioral health in&#xD;
      relation to all health, use evidence-based health promotion in addition to evidence based&#xD;
      treatment of existing problems, and intervene early in children's life.&#xD;
&#xD;
      The VFBA is a public health framework for evidence-based health promotion, prevention, and&#xD;
      treatment that is delivered from the family perspective and emphasizes emotional and&#xD;
      behavioral health.&#xD;
&#xD;
      The study was a pilot RCT of the VFBA in a primary care pediatrics clinic. The goals of the&#xD;
      study were to test whether the VFBA would (1) be feasible in primary care pediatrics and (2)&#xD;
      would lead to improved emotional and behavioral health and health-related quality of life or&#xD;
      children and parents. Families were recruited at the pediatric clinic and randomized to the&#xD;
      VFBA or Control conditions.&#xD;
&#xD;
      The VFBA group received family-based assessment of emotional and behavioral health and family&#xD;
      functioning, family wellness coaching, and a menu of cost-free wellness activities, such as&#xD;
      parent and child violin instruction, yoga and mindfulness training, and nutrition counseling.&#xD;
      Where indicated by results of family-based assessment, families in the VFBA group also&#xD;
      received family-based, evidence-based psychotherapy and psychiatric care. Families in the&#xD;
      Control group received pediatric primary care, as usual.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2015</start_date>
  <completion_date type="Actual">June 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility Index 1</measure>
    <time_frame>during study enrollment</time_frame>
    <description>descriptive statistics for the number of family visits with FWCs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility Index 2</measure>
    <time_frame>during study enrollment</time_frame>
    <description>descriptive statistics for the number of family visits with FFCs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility Index 3</measure>
    <time_frame>during study enrollment</time_frame>
    <description>number of health and wellness supports and services the family engaged with</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Children's Emotional and Behavioral Problems</measure>
    <time_frame>Baseline, 12 month assessment (final assessment)</time_frame>
    <description>The Child Behavior Checklist (CBCL) Total Problems Score (Range: 0-224; higher scores indicate more emotional and behavioral problems)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children's Health Related Quality of Life</measure>
    <time_frame>Baseline, 12 month assessment (final assessment)</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parents' Emotional and Behavioral Problems</measure>
    <time_frame>Baseline, 12 month assessment (final assessment)</time_frame>
    <description>The Adult Self-Report (ASR) Total Problems Score (Range: 0-224; higher scores indicate higher levels of emotional and behavioral problems)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life of Caregivers</measure>
    <time_frame>Baseline, 12 month assessment (final assessment)</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Psychiatric Disorder</condition>
  <arm_group>
    <arm_group_label>Vermont Family Based Approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The VFBA group was offered a variety of supports and services to help them achieve and maintain wellness and address emotional behavioral challenges.&#xD;
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.&#xD;
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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Control Group received pediatric care as usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vermont Family Based Approach</intervention_name>
    <description>Comprehensive and individualized program to promote emotional health and wellbeing in families using evidence-based health promotion, prevention and intervention.</description>
    <arm_group_label>Vermont Family Based Approach</arm_group_label>
    <other_name>VFBA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Treatment as Usual</intervention_name>
    <description>Pediatric care as usual.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>TAU</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Families with a 3 - 15 year-old child who receives his/her primary care at the&#xD;
             University of Vermont Pediatric Primary Care Clinic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Families with a target child in the legal custody of the State of Vermont&#xD;
&#xD;
          -  Families where the parents' proficiency in English is not sufficient to participate in&#xD;
             the protocol without an interpreter&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James J Hudziak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vermont Center for Children, Youth &amp; Families</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Achenbach, T. M., &amp; Rescorla, L. A. (2003). Manual for the ASEBA Adult Forms &amp; Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, &amp; Families.</citation>
  </reference>
  <reference>
    <citation>Achenbach, T.M., &amp; Rescorla, L.A. (2003). Manual for the ASEBA School-Age Forms &amp; Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth &amp; Families.</citation>
  </reference>
  <reference>
    <citation>Achenbach, T.M., &amp; Rescorla, L.A. (2000). Manual for the ASEBA Preschool Forms &amp; Profiles. Burlington, VT: University of Vermont, Research Center for Children, Youth, and Families.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15110427</PMID>
  </reference>
  <reference>
    <citation>Hudziak, J.J., &amp; 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.</citation>
  </reference>
  <reference>
    <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. doi: 10.1097/00005650-199303000-00006.</citation>
    <PMID>8450681</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8277801</PMID>
  </reference>
  <reference>
    <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. doi: 10.1136/jech.2003.012914.</citation>
    <PMID>15598731</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>1593914</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26980122</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 9, 2015</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 31, 2020</last_update_submitted>
  <last_update_submitted_qc>May 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont Medical Center</investigator_affiliation>
    <investigator_full_name>James Hudziak</investigator_full_name>
    <investigator_title>Professor of Psychiatry, Medicine, Pediatrics, and Communication Sciences &amp; Disorders; Director of the Vermont Center for Children, Youth &amp; Families</investigator_title>
  </responsible_party>
  <keyword>Health Promotion</keyword>
  <keyword>Prevention</keyword>
  <keyword>Mental health</keyword>
  <keyword>Quality of life</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Wellness</keyword>
  <keyword>Preventive Medicine</keyword>
  <keyword>Preventive Psychiatry</keyword>
  <keyword>Patient Participation</keyword>
  <keyword>Health Literacy</keyword>
  <keyword>Patient Activation</keyword>
  <keyword>Patient Engagement</keyword>
  <keyword>Emotional Health</keyword>
  <keyword>Behavioral Health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Problem Behavior</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04412590
org study id: CHRMS 16-004
nct id: NCT04412590
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Feasibility Index 1
time frame: during study enrollment
description: descriptive statistics for the number of family visits with FWCs
measure: Feasibility Index 2
time frame: during study enrollment
description: descriptive statistics for the number of family visits with FFCs
measure: Feasibility Index 3
time frame: during study enrollment
description: number of health and wellness supports and services the family engaged with
measure: Children's Emotional and Behavioral Problems
time frame: Baseline, 12 month assessment (final assessment)
description: The Child Behavior Checklist (CBCL) Total Problems Score (Range: 0-224; higher scores indicate more emotional and behavioral problems)
measure: Children's Health Related Quality of Life
time frame: Baseline, 12 month assessment (final assessment)
description: 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)
measure: Parents' Emotional and Behavioral Problems
time frame: Baseline, 12 month assessment (final assessment)
description: The Adult Self-Report (ASR) Total Problems Score (Range: 0-224; higher scores indicate higher levels of emotional and behavioral problems)
measure: Health Related Quality of Life of Caregivers
time frame: Baseline, 12 month assessment (final assessment)
description: 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)
arm group label: Vermont Family Based Approach
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: Active Comparator
description: The Control Group received pediatric care as usual.
intervention type: Other
intervention name: Vermont Family Based Approach
description: Comprehensive and individualized program to promote emotional health and wellbeing in families using evidence-based health promotion, prevention and intervention.
arm group label: Vermont Family Based Approach
other name: VFBA
intervention type: Other
intervention name: Treatment as Usual
description: Pediatric care as usual.
arm group label: Control
other name: TAU
criteria: 
gender: All
minimum age: 3 Years
maximum age: 15 Years
healthy volunteers: Accepts Healthy Volunteers
last name: James J Hudziak, MD
role: Principal Investigator
affiliation: University of Vermont Medical Center
facility: 
country: United States
citation: 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.
citation: 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.
citation: 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.
citation: 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
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.
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. doi: 10.1097/00005650-199303000-00006.
PMID: 8450681
citation: 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
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. doi: 10.1136/jech.2003.012914.
PMID: 15598731
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.
PMID: 1593914
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.
PMID: 26980122
responsible party type: Principal Investigator
investigator affiliation: University of Vermont Medical Center
investigator full name: James Hudziak
investigator title: Professor of Psychiatry, Medicine, Pediatrics, and Communication Sciences & Disorders; Director of the Vermont Center for Children, Youth & Families
mesh term: Mental Disorders
mesh term: Problem Behavior
sharing ipd: No