<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/NCT02973906</url>
  </required_header>
  <id_info>
    <org_study_id>1407S52001</org_study_id>
    <nct_id>NCT02973906</nct_id>
  </id_info>
  <brief_title>Comparing Web, Group, and Telehealth Formats of a Military Parenting Program</brief_title>
  <official_title>Comparing Web, Group, and Telehealth Formats of a Military Parenting Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overarching goal of this study is to advance research on family-based prevention of&#xD;
      negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom&#xD;
      personnel by evaluating different formats of a parenting program, After Deployment, Adaptive&#xD;
      Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management&#xD;
      Training-Oregon Model/PMTO, but adapted for military deployed families. The PI will examine&#xD;
      which of three delivery formats of ADAPT is most effective at reducing youth risk behaviors&#xD;
      associated with negative childhood outcomes by improving parenting, child, and parent&#xD;
      adjustment. There is a clear intent to benefit all subjects in this study (except surveyed&#xD;
      teachers), including children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overarching goal of this study is to advance research on family-based prevention of&#xD;
      negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom&#xD;
      personnel by evaluating different formats of a parenting program, After Deployment, Adaptive&#xD;
      Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management&#xD;
      Training-Oregon Model/PMTO, but adapted for military deployed families. The investigators&#xD;
      will examine which of three delivery formats of ADAPT is most effective at reducing youth&#xD;
      risk behaviors associated with negative childhood outcomes by improving parenting, child, and&#xD;
      parent adjustment. There is a clear intent to benefit all subjects in this study (except&#xD;
      surveyed teachers), including children.&#xD;
&#xD;
      Combat deployment and related challenges are family stressors, associated with more negative&#xD;
      parent-child interactions, ineffective and coercive parenting practices and lower levels of&#xD;
      parenting satisfaction. Disrupted parenting practices are well-known predictors of risk for&#xD;
      child adjustment difficulties that are precursors to youth substance use, including behavior&#xD;
      problems, school failure, deviant peer association, and depression . These child adjustment&#xD;
      problems can contribute to continuing parental stress, increasing parental distress, and&#xD;
      further disrupting parenting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2014</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</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>Change in parenting practices and parent/child interactions</measure>
    <time_frame>Change from Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Observed parenting is coded using FIT (Family Interaction Task) and self-report of parenting using the APQ (Alabama parenting Questionnaire),</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in child adjustment and substance use</measure>
    <time_frame>Change from Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Child adjustment assessed using BASC-2 (teacher, parent, and child self-report); Child intentions and use of substances assess using the Alcohol Use Intentions and Behavior Scale; Child distress measured by CDI (Children's Depression Inventory); Child peer adjustment is measured by 16-item scale assessing loneliness and dissatisfaction with peer relations; Deviant peer association measured using &quot;Describing Friends&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in parenting stress and support</measure>
    <time_frame>Change from Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Parenting Stress Index-Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant report of satisfaction with intervention</measure>
    <time_frame>Change from Baseline, 6 months, 12 months, 24 months</time_frame>
    <description>Two 10-item measures: (1) group satisfaction and (2) online satisfaction</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">244</enrollment>
  <condition>Parenting</condition>
  <arm_group>
    <arm_group_label>ADAPT Self Directed web</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>ADAPT Self Directed Web. In the self-directed web-only ADAPT condition, participants have access to the full ADAPT website (10 modules, online discussion forum)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ADAPT individualized web-facilitated</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>This condition comprises access to the full ADAPT web program with augmentation of individual facilitator web support (i.e. the facilitator connects via Google Hangout). Facilitators meet with families at a mutually convenient time weekly (10-14 weeks, approximately 3 sessions per month).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-based ADAPT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Groups will meet weekly for 120 minutes, at a time convenient to participants (usually early evening). Groups cover core ADAPT/PMTO topics</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ADAPT Self Directed web</intervention_name>
    <description>In the self-directed web-only ADAPT condition, participants have access to the full ADAPT website (10 modules, online discussion forum</description>
    <arm_group_label>ADAPT Self Directed web</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ADAPT individualized web-facilitated</intervention_name>
    <description>This condition comprises access to the full ADAPT web program as described above, with augmentation of individual facilitator web support (i.e. the facilitator connects via Google Hangout). Facilitators meet with families at a mutually convenient time weekly (10-14 weeks, approximately 3 sessions per month).</description>
    <arm_group_label>ADAPT individualized web-facilitated</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group-based ADAPT</intervention_name>
    <description>Groups will meet weekly for 120 minutes, at a time convenient to participants (usually early evening). Groups cover core ADAPT/PMTO topics:</description>
    <arm_group_label>Group-based ADAPT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion criteria are:&#xD;
&#xD;
          -  one parent has returned from deployment to OIF or OEF&#xD;
&#xD;
          -  at least one child ages 5-12 in their custody and living with parent(s) in the home&#xD;
&#xD;
          -  high speed internet access at home We will include both single-and two-parent&#xD;
             families, as well as families where care is shared between non-partnered adults (e.g.&#xD;
             grandparent and mother)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active psychosis&#xD;
&#xD;
          -  an open child protection case for abuse or neglect in the family&#xD;
&#xD;
          -  a serious child mental health diagnosis&#xD;
&#xD;
          -  families who piloted material or participated in or are currently participating in the&#xD;
             original ADAPT RCT.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abigail Gweitrz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute for Translational Research in Children's Mental Health University of Minnesota</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute for Translational Research in Children's Mental Health</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 4, 2015</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>May 6, 2021</last_update_submitted>
  <last_update_submitted_qc>May 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 4, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/06/NCT02973906/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02973906
org study id: 1407S52001
nct id: NCT02973906
lead sponsor: 
has dmc: No
The overarching goal of this study is to advance research on family-based prevention of
      negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom
      personnel by evaluating different formats of a parenting program, After Deployment, Adaptive
      Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management
      Training-Oregon Model/PMTO, but adapted for military deployed families. The PI will examine
      which of three delivery formats of ADAPT is most effective at reducing youth risk behaviors
      associated with negative childhood outcomes by improving parenting, child, and parent
      adjustment. There is a clear intent to benefit all subjects in this study (except surveyed
      teachers), including children.
The overarching goal of this study is to advance research on family-based prevention of
      negative child outcomes for reintegrating Operation Enduring Freedom/Operation Iraqi Freedom
      personnel by evaluating different formats of a parenting program, After Deployment, Adaptive
      Parenting Tools (ADAPT). The ADAPT program is based upon the Parent Management
      Training-Oregon Model/PMTO, but adapted for military deployed families. The investigators
      will examine which of three delivery formats of ADAPT is most effective at reducing youth
      risk behaviors associated with negative childhood outcomes by improving parenting, child, and
      parent adjustment. There is a clear intent to benefit all subjects in this study (except
      surveyed teachers), including children.

      Combat deployment and related challenges are family stressors, associated with more negative
      parent-child interactions, ineffective and coercive parenting practices and lower levels of
      parenting satisfaction. Disrupted parenting practices are well-known predictors of risk for
      child adjustment difficulties that are precursors to youth substance use, including behavior
      problems, school failure, deviant peer association, and depression . These child adjustment
      problems can contribute to continuing parental stress, increasing parental distress, and
      further disrupting parenting.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in parenting practices and parent/child interactions
time frame: Change from Baseline, 6 months, 12 months, 24 months
description: Observed parenting is coded using FIT (Family Interaction Task) and self-report of parenting using the APQ (Alabama parenting Questionnaire),
measure: Change in child adjustment and substance use
time frame: Change from Baseline, 6 months, 12 months, 24 months
description: Child adjustment assessed using BASC-2 (teacher, parent, and child self-report); Child intentions and use of substances assess using the Alcohol Use Intentions and Behavior Scale; Child distress measured by CDI (Children's Depression Inventory); Child peer adjustment is measured by 16-item scale assessing loneliness and dissatisfaction with peer relations; Deviant peer association measured using "Describing Friends"
measure: Change in parenting stress and support
time frame: Change from Baseline, 6 months, 12 months, 24 months
description: Parenting Stress Index-Short Form
measure: Participant report of satisfaction with intervention
time frame: Change from Baseline, 6 months, 12 months, 24 months
description: Two 10-item measures: (1) group satisfaction and (2) online satisfaction
arm group label: ADAPT Self Directed web
arm group type: Other
description: ADAPT Self Directed Web. In the self-directed web-only ADAPT condition, participants have access to the full ADAPT website (10 modules, online discussion forum)
arm group label: ADAPT individualized web-facilitated
arm group type: Other
description: This condition comprises access to the full ADAPT web program with augmentation of individual facilitator web support (i.e. the facilitator connects via Google Hangout). Facilitators meet with families at a mutually convenient time weekly (10-14 weeks, approximately 3 sessions per month).
arm group label: Group-based ADAPT
arm group type: Other
description: Groups will meet weekly for 120 minutes, at a time convenient to participants (usually early evening). Groups cover core ADAPT/PMTO topics
intervention type: Other
intervention name: ADAPT Self Directed web
description: In the self-directed web-only ADAPT condition, participants have access to the full ADAPT website (10 modules, online discussion forum
arm group label: ADAPT Self Directed web
intervention type: Other
intervention name: ADAPT individualized web-facilitated
description: This condition comprises access to the full ADAPT web program as described above, with augmentation of individual facilitator web support (i.e. the facilitator connects via Google Hangout). Facilitators meet with families at a mutually convenient time weekly (10-14 weeks, approximately 3 sessions per month).
arm group label: ADAPT individualized web-facilitated
intervention type: Other
intervention name: Group-based ADAPT
description: Groups will meet weekly for 120 minutes, at a time convenient to participants (usually early evening). Groups cover core ADAPT/PMTO topics:
arm group label: Group-based ADAPT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Abigail Gweitrz, PhD
role: Principal Investigator
affiliation: Institute for Translational Research in Children's Mental Health University of Minnesota
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided
provided document: 