<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/NCT03750487</url>
  </required_header>
  <id_info>
    <org_study_id>HELP 2.0</org_study_id>
    <secondary_id>R34DA045831</secondary_id>
    <nct_id>NCT03750487</nct_id>
  </id_info>
  <brief_title>Home Visitation Enhancing Linkages Project</brief_title>
  <acronym>HELP</acronym>
  <official_title>Home Visitation Enhancing Linkages Project (HELP 2.0)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The National Center on Addiction and Substance Abuse at Columbia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>The National Center on Addiction and Substance Abuse at Columbia University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      A small pilot randomized controlled trial (RCT) will be conducted to test the impact of an&#xD;
      electronic screening and brief intervention (e-SBI) on reduction in substance use (measured&#xD;
      via self-report), associated symptoms (depression and parenting stress), and improvement in&#xD;
      home visiting retention and substance use treatment engagement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this clinical trial is to pilot test an electronic screening and brief&#xD;
      intervention (e-SBI) that will be adapted for use with pregnant and postpartum women in home&#xD;
      visiting (HV) programs. The e-SBI will be tested in a small randomized trial in two home&#xD;
      visiting sites, with 10 home visitors and 40 clients. Home visitors will be randomized to the&#xD;
      control intervention or the e-SBI. Clients will be surveyed at baseline, and 3- and 6- month&#xD;
      follow-up to track e-SBI impacts on reduction in substance use (measured via self-report),&#xD;
      associated symptoms (depression and parenting stress), and improvement in home visiting&#xD;
      retention and substance use treatment engagement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Timeline Follow Back Interview</measure>
    <time_frame>baseline</time_frame>
    <description>Calendar-based method for assessing substance use. Outcome will include self-reported days of use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timeline Follow Back Interview</measure>
    <time_frame>3 month follow-up</time_frame>
    <description>Calendar-based method for assessing substance use. Outcome will include self-reported days of use.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Timeline Follow Back Interview</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Calendar-based method for assessing substance use. Outcome will include self-reported days of use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Edinburgh Postnatal Depression Scale</measure>
    <time_frame>baseline, 3- and 6-month follow-up</time_frame>
    <description>10-item scale measuring perinatal depressive symptoms. Total score range is 0-30, with depression possible with a score of 10 or higher.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parenting Stress Index-Short Form</measure>
    <time_frame>baseline, 3- and 6-month follow-up</time_frame>
    <description>36-item measure of stress associated with parenting. Subscales include parental distress, parent-child dysfunctional interaction, and difficult child, leading to a total stress indicator. Scores are calculated as percentiles: 15-80 are typical percentiles, with clinically significant levels starting at 85 for the parent-child dysfunctional interaction subscale and 90 for all other subscales. Defensive responding is defined as a raw score below ten.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention in Home Visiting</measure>
    <time_frame>6 months</time_frame>
    <description>The number of home visits attended in the home visiting program will be mined from the home visiting program's management information system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Services Review</measure>
    <time_frame>6 months</time_frame>
    <description>Will use the Treatment Services Review to gather client report on attendance at any substance use treatment during the study period.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Substance Use</condition>
  <arm_group>
    <arm_group_label>e-screening &amp; brief intervention (e-SBI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A two-session (20 minutes each) computer-delivered screening and brief motivational intervention targeting alcohol and drug use. Computerized screening is conducted using the ASSIST. Session 1 of the BI includes personalized feedback, readiness to change interventions, and goal setting around substance use. Session 2 will contain motivational content reinforcing engagement in home visiting and information around other challenges mothers may experience including tobacco use, postpartum depression, and intimate partner violence.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The control group will receive a similar 2-session brief motivational intervention. Session 1 focuses on nutrition and healthy eating, session 2 focuses on exercising while pregnant or in the postpartum period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>e-screening &amp; brief intervention (e-SBI)</intervention_name>
    <description>Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement</description>
    <arm_group_label>e-screening &amp; brief intervention (e-SBI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control e-SBI</intervention_name>
    <description>Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English-speaking,&#xD;
&#xD;
          -  18 years or older,&#xD;
&#xD;
          -  pregnant or up to 3 months postpartum,&#xD;
&#xD;
          -  newly enrolling in home visiting with a participating home visitor,&#xD;
&#xD;
          -  not currently attending substance use treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Dauber, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Partnership to End Addiction (formerly CASAColumbia)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sarah Dauber, PhD</last_name>
    <phone>2128415270</phone>
    <email>sdauber@centeronaddiction.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Cori L Hammond, MPH</last_name>
    <phone>2128415304</phone>
    <email>chammond@centeronaddiction.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Partnership to End Addiction - 485</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cori Hammond, MPH</last_name>
      <phone>704-662-2777</phone>
      <email>chammond@toendaddiction.org</email>
    </contact>
    <investigator>
      <last_name>Sarah Dauber, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>November 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 23, 2018</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</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/NCT03750487
org study id: HELP 2.0
secondary id: R34DA045831
nct id: NCT03750487
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A small pilot randomized controlled trial (RCT) will be conducted to test the impact of an
      electronic screening and brief intervention (e-SBI) on reduction in substance use (measured
      via self-report), associated symptoms (depression and parenting stress), and improvement in
      home visiting retention and substance use treatment engagement.
The purpose of this clinical trial is to pilot test an electronic screening and brief
      intervention (e-SBI) that will be adapted for use with pregnant and postpartum women in home
      visiting (HV) programs. The e-SBI will be tested in a small randomized trial in two home
      visiting sites, with 10 home visitors and 40 clients. Home visitors will be randomized to the
      control intervention or the e-SBI. Clients will be surveyed at baseline, and 3- and 6- month
      follow-up to track e-SBI impacts on reduction in substance use (measured via self-report),
      associated symptoms (depression and parenting stress), and improvement in home visiting
      retention and substance use treatment engagement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Timeline Follow Back Interview
time frame: baseline
description: Calendar-based method for assessing substance use. Outcome will include self-reported days of use.
measure: Timeline Follow Back Interview
time frame: 3 month follow-up
description: Calendar-based method for assessing substance use. Outcome will include self-reported days of use.
measure: Timeline Follow Back Interview
time frame: 6-month follow-up
description: Calendar-based method for assessing substance use. Outcome will include self-reported days of use.
measure: Edinburgh Postnatal Depression Scale
time frame: baseline, 3- and 6-month follow-up
description: 10-item scale measuring perinatal depressive symptoms. Total score range is 0-30, with depression possible with a score of 10 or higher.
measure: Parenting Stress Index-Short Form
time frame: baseline, 3- and 6-month follow-up
description: 36-item measure of stress associated with parenting. Subscales include parental distress, parent-child dysfunctional interaction, and difficult child, leading to a total stress indicator. Scores are calculated as percentiles: 15-80 are typical percentiles, with clinically significant levels starting at 85 for the parent-child dysfunctional interaction subscale and 90 for all other subscales. Defensive responding is defined as a raw score below ten.
measure: Retention in Home Visiting
time frame: 6 months
description: The number of home visits attended in the home visiting program will be mined from the home visiting program's management information system.
measure: Treatment Services Review
time frame: 6 months
description: Will use the Treatment Services Review to gather client report on attendance at any substance use treatment during the study period.
arm group label: e-screening & brief intervention (e-SBI)
arm group type: Experimental
description: A two-session (20 minutes each) computer-delivered screening and brief motivational intervention targeting alcohol and drug use. Computerized screening is conducted using the ASSIST. Session 1 of the BI includes personalized feedback, readiness to change interventions, and goal setting around substance use. Session 2 will contain motivational content reinforcing engagement in home visiting and information around other challenges mothers may experience including tobacco use, postpartum depression, and intimate partner violence.
arm group label: Control
arm group type: Sham Comparator
description: The control group will receive a similar 2-session brief motivational intervention. Session 1 focuses on nutrition and healthy eating, session 2 focuses on exercising while pregnant or in the postpartum period.
intervention type: Behavioral
intervention name: e-screening & brief intervention (e-SBI)
description: Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement
arm group label: e-screening & brief intervention (e-SBI)
intervention type: Behavioral
intervention name: Control e-SBI
description: Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise
arm group label: Control
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Dauber, PhD
role: Principal Investigator
affiliation: Partnership to End Addiction (formerly CASAColumbia)
last name: Sarah Dauber, PhD
phone: 2128415270
email: sdauber@centeronaddiction.org
last name: Cori L Hammond, MPH
phone: 2128415304
email: chammond@centeronaddiction.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders