<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/NCT03282448</url>
  </required_header>
  <id_info>
    <org_study_id>29987</org_study_id>
    <secondary_id>UL1TR001086</secondary_id>
    <nct_id>NCT03282448</nct_id>
  </id_info>
  <brief_title>Video-based Family Therapy for Peripartum Depression in Home Visited Mothers</brief_title>
  <official_title>Integrated Video-based Family Therapy for Peripartum Depression in Home Visited Mothers: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fallon P. Cluxton-Keller</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock 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 study will explore the feasibility and acceptability of implementing a&#xD;
      family-based treatment, using HIPAA-compliant video-based communication technology, for&#xD;
      adolescents (pregnant and post-delivery) with peripartum depressive symptoms within the&#xD;
      context of home visiting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the pilot study is to partner with two Federal Maternal, Infant and Early&#xD;
      Childhood Home Visiting (HV) Program sites to implement a family-based treatment for&#xD;
      depression, using HIPAA-compliant video-based communication technology, in adolescent mothers&#xD;
      (pregnant and post-delivery). This implementation-effectiveness hybrid trial includes&#xD;
      depressed adolescent mothers and their adult family members.&#xD;
&#xD;
      It has three aims:&#xD;
&#xD;
        1. Explore the feasibility of integrating the treatment model into two Federal HV Program&#xD;
           sites in New Hampshire.&#xD;
&#xD;
        2. Test the acceptability of the treatment model among depressed adolescent mothers and&#xD;
           their families.&#xD;
&#xD;
        3. Explore preliminary impacts of the treatment on maternal depressive symptoms and&#xD;
           parenting attitudes, family emotion regulation, and family functioning at two months&#xD;
           post-intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2017</start_date>
  <completion_date type="Actual">June 13, 2018</completion_date>
  <primary_completion_date type="Actual">June 13, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal depressive symptoms</measure>
    <time_frame>5 months</time_frame>
    <description>Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II; Beck, Steer, &amp; Brown, 1996)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Therapist-family working alliance</measure>
    <time_frame>2.5 months</time_frame>
    <description>Clinician rated, and maternal report and family member report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Satisfaction</measure>
    <time_frame>2.5 months</time_frame>
    <description>Maternal report and family member report.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting attitudes</measure>
    <time_frame>5 months</time_frame>
    <description>A reliable and valid self-report measure will be completed by mothers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emotion regulation</measure>
    <time_frame>5 months</time_frame>
    <description>A reliable and valid self-report measure will be completed by mothers and their family members.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family functioning</measure>
    <time_frame>5 months</time_frame>
    <description>A reliable and valid self-report measure will be completed by mothers and their family members.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Peripartum Depression</condition>
  <arm_group>
    <arm_group_label>Family therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adolescent mothers and their family members will receive a total of 10 weekly, 30-minute, video-based family therapy sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical comparison group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The Edinburgh Postnatal Depression Scale scores of adolescent mothers in the intervention group will be compared to those of adolescent mothers, who were previously enrolled in the home visiting programs, at the same time points.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>family therapy</intervention_name>
    <description>The family-based intervention is informed by Dialectical Behavior Therapy Skills Training for Adolescents (Rathus &amp; Miller, 2014).</description>
    <arm_group_label>Family therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Home Visitor Inclusion Criteria:&#xD;
&#xD;
          1. Willingness to participate in the study;&#xD;
&#xD;
          2. Intention to remain in current job for at least 12 months; and&#xD;
&#xD;
          3. Fluency in English: The training, treatment model, implementation meetings, and&#xD;
             supervision sessions will be carried out in English.&#xD;
&#xD;
        Family Inclusion Criteria:&#xD;
&#xD;
          1. Adolescent mothers, ages 13-25, in the first trimester of pregnancy through eighteen&#xD;
             months postpartum;&#xD;
&#xD;
          2. Adolescent mothers with Edinburgh Postnatal Depression Scale scores of ≥8;&#xD;
&#xD;
          3. At least one of the adolescent mother's family members (&quot;family member&quot; is defined as&#xD;
             a person she is biologically related to, or significant close others/partners with&#xD;
             whom she is not biologically related) must be willing and available to participate in&#xD;
             eight of the 10 video-based family therapy sessions;&#xD;
&#xD;
          4. Fluency in English: The treatment will be carried out in English; and&#xD;
&#xD;
          5. Consistent internet access (i.e., subscribe to an internet service provider and do not&#xD;
             experience weekly disruptions in service) on a cell phone, tablet, or computer&#xD;
             equipped with a camera and microphone.&#xD;
&#xD;
        Family Exclusion Criteria:&#xD;
&#xD;
        Adolescent mothers with&#xD;
&#xD;
          1. A current positive screen for problem alcohol use on the CAGE or TWEAK;&#xD;
&#xD;
          2. A current positive screen on the drug abuse items on the home visiting interview;&#xD;
&#xD;
          3. A current positive screen for domestic violence on the Relationship Assessment Tool;&#xD;
&#xD;
          4. Current hallucinations and/or delusions;&#xD;
&#xD;
          5. Current homicidal ideation;&#xD;
&#xD;
          6. Current suicidal ideation;&#xD;
&#xD;
          7. Current severe major depressive episode as measured by the SCID-V Depression Module&#xD;
             for those over age 18, or NIMH DISC-Y &amp; DISC-P Mood Module for those under age 18;&#xD;
             and/or&#xD;
&#xD;
          8. Current self-injurious behavior (e.g., cutting arms on a weekly basis). Families with&#xD;
&#xD;
          9. Current Child Protection Service involvement;&#xD;
&#xD;
         10. Current family therapy service involvement; and/or&#xD;
&#xD;
         11. Current or previous Dialectical Behavior Therapy (DBT) treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fallon P. Cluxton-Keller, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Craig L. Donnelly, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martha L. Bruce, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Dartmouth College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TLC Family Resource Center</name>
      <address>
        <city>Claremont</city>
        <state>New Hampshire</state>
        <zip>03743</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Family Resource Center at Gorham</name>
      <address>
        <city>Gorham</city>
        <state>New Hampshire</state>
        <zip>03581</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>June 16, 2018</last_update_submitted>
  <last_update_submitted_qc>June 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Fallon P. Cluxton-Keller</investigator_full_name>
    <investigator_title>Assistant Professor Psychiatry</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT03282448
org study id: 29987
secondary id: UL1TR001086
nct id: NCT03282448
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study will explore the feasibility and acceptability of implementing a
      family-based treatment, using HIPAA-compliant video-based communication technology, for
      adolescents (pregnant and post-delivery) with peripartum depressive symptoms within the
      context of home visiting.
The purpose of the pilot study is to partner with two Federal Maternal, Infant and Early
      Childhood Home Visiting (HV) Program sites to implement a family-based treatment for
      depression, using HIPAA-compliant video-based communication technology, in adolescent mothers
      (pregnant and post-delivery). This implementation-effectiveness hybrid trial includes
      depressed adolescent mothers and their adult family members.

      It has three aims:

        1. Explore the feasibility of integrating the treatment model into two Federal HV Program
           sites in New Hampshire.

        2. Test the acceptability of the treatment model among depressed adolescent mothers and
           their families.

        3. Explore preliminary impacts of the treatment on maternal depressive symptoms and
           parenting attitudes, family emotion regulation, and family functioning at two months
           post-intervention.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Maternal depressive symptoms
time frame: 5 months
description: Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
measure: Therapist-family working alliance
time frame: 2.5 months
description: Clinician rated, and maternal report and family member report.
measure: Family Satisfaction
time frame: 2.5 months
description: Maternal report and family member report.
measure: Parenting attitudes
time frame: 5 months
description: A reliable and valid self-report measure will be completed by mothers.
measure: Emotion regulation
time frame: 5 months
description: A reliable and valid self-report measure will be completed by mothers and their family members.
measure: Family functioning
time frame: 5 months
description: A reliable and valid self-report measure will be completed by mothers and their family members.
arm group label: Family therapy
arm group type: Experimental
description: Adolescent mothers and their family members will receive a total of 10 weekly, 30-minute, video-based family therapy sessions.
arm group label: Historical comparison group
arm group type: No Intervention
description: The Edinburgh Postnatal Depression Scale scores of adolescent mothers in the intervention group will be compared to those of adolescent mothers, who were previously enrolled in the home visiting programs, at the same time points.
intervention type: Behavioral
intervention name: family therapy
description: The family-based intervention is informed by Dialectical Behavior Therapy Skills Training for Adolescents (Rathus & Miller, 2014).
arm group label: Family therapy
criteria: 
gender: All
minimum age: 13 Years
maximum age: 25 Years
healthy volunteers: No
last name: Fallon P. Cluxton-Keller, Ph.D.
role: Principal Investigator
affiliation: Dartmouth College
last name: Craig L. Donnelly, M.D.
role: Principal Investigator
affiliation: Dartmouth College
last name: Martha L. Bruce, Ph.D.
role: Study Chair
affiliation: Dartmouth College
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Fallon P. Cluxton-Keller
investigator title: Assistant Professor Psychiatry
mesh term: Depression
mesh term: Depressive Disorder