<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/NCT02191605</url>
  </required_header>
  <id_info>
    <org_study_id>R34DA036788</org_study_id>
    <secondary_id>1R34DA036788</secondary_id>
    <nct_id>NCT02191605</nct_id>
  </id_info>
  <brief_title>Computer-delivered Screening &amp; Brief Intervention for Marijuana Use in Pregnancy</brief_title>
  <official_title>Computer-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) for Marijuana Use in Pregnancy: Planning a Stage II Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wayne State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Wayne State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal&#xD;
      exposure to marijuana can have lasting negative effects. However, current answers to this&#xD;
      problem are failing to reach most women who use marijuana while pregnant. This project will&#xD;
      develop and begin testing two technology-based, highly practical interventions that could&#xD;
      reduce the number of children who are prenatally exposed to marijuana.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There are at present no evidence-based interventions for marijuana use during pregnancy,&#xD;
      despite its being by far the most commonly used illicit drug during pregnancy (particularly&#xD;
      among African-American women), and despite growing evidence that it may have a range of&#xD;
      long-term cognitive and neurobehavioral consequences. This R34 clinical trial planning grant&#xD;
      therefore proposes the development and preliminary validation of two high- reach and mutually&#xD;
      compatible technology-based interventions for marijuana use during pregnancy. The first, a&#xD;
      theory-based, synchronous, and highly interactive computer-delivered brief intervention, will&#xD;
      be based on an emerging knowledge base regarding key elements of efficacious&#xD;
      technology-delivered interventions. The second intervention, a series of tailored text&#xD;
      messages, will build on the rich literature regarding key tailoring elements. These&#xD;
      interventions will be developed and refined with input from pregnant women who report active&#xD;
      use of marijuana, as well as from health care providers. They will subsequently be&#xD;
      tested-alone and in combination-in a pilot randomized trial involving 80 women actively using&#xD;
      marijuana during pregnancy. This Stage I pilot work would set the stage for a confirmatory&#xD;
      Stage II trial. It would also produce the first high-reach brief interventions for marijuana&#xD;
      use during pregnancy. If effective, these approaches could have a substantial population&#xD;
      impact on marijuana use among pregnant women, with potential for lifelong improved outcomes&#xD;
      for both mother and child.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2015</start_date>
  <completion_date type="Actual">October 27, 2017</completion_date>
  <primary_completion_date type="Actual">April 20, 2017</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery</measure>
    <time_frame>self-reported use during 7 days prior to delivery of their baby</time_frame>
    <description>Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and urine analysis. This will represent the number of participants who abstinent (reported no marijuana use and had a negative toxicology urine screen) from marijuana for the 7 days prior to delivery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery</measure>
    <time_frame>self-reported use during 90 days prior to delivery of their baby</time_frame>
    <description>Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and hair toxicology analysis. This will represent the number of participants who were abstinent (reported no marijuana use and had a negative hair toxicology results) from marijuana for the 90 days prior to delivery.</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Marijuana Use</condition>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>electronic SBIRT (eSBIRT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tailored texting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>eSBIRT &amp; texting</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assessment only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Screening only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eSBIRT</intervention_name>
    <description>A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.</description>
    <arm_group_label>eSBIRT &amp; texting</arm_group_label>
    <arm_group_label>electronic SBIRT (eSBIRT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tailored texting</intervention_name>
    <description>Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
    <arm_group_label>Tailored texting</arm_group_label>
    <arm_group_label>eSBIRT &amp; texting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 to 40 years of age&#xD;
&#xD;
          -  20 weeks or less gestation&#xD;
&#xD;
          -  intention to carry pregnancy to term&#xD;
&#xD;
          -  self-reported marijuana use in month before pregnancy&#xD;
&#xD;
          -  own a cell phone and willingness to receive text messages&#xD;
&#xD;
          -  gives consent to access medical records for collection of birth outcome data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  frank cognitive impairment or psychosis&#xD;
&#xD;
          -  not able to communicate in English&#xD;
&#xD;
          -  not planning to deliver at a Detroit Medical Center (DMC) hospital&#xD;
&#xD;
          -  previous or current participant in a study conducted by Dr. Ondersma&#xD;
&#xD;
          -  Eunice Kennedy Shriver National Institute of Child Health and Human Development&#xD;
             (NICHD) Perinatal Research Branch participant.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven J Ondersma, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wayne State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wayne State University</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</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>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>July 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <results_first_submitted>May 1, 2018</results_first_submitted>
  <results_first_submitted_qc>June 4, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2018</results_first_posted>
  <last_update_submitted>June 4, 2018</last_update_submitted>
  <last_update_submitted_qc>June 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wayne State University</investigator_affiliation>
    <investigator_full_name>Steven J. Ondersma</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Computerized Brief Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Marijuana Abuse</mesh_term>
    <mesh_term>Marijuana Use</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT02191605/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Electronic SBIRT (eSBIRT)</title>
          <description>Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.&#xD;
eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.</description>
        </group>
        <group group_id="P2">
          <title>Tailored Texting</title>
          <description>Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.&#xD;
Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
        </group>
        <group group_id="P3">
          <title>eSBIRT &amp; Texting</title>
          <description>Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.&#xD;
eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.&#xD;
Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
        </group>
        <group group_id="P4">
          <title>Assessment Only</title>
          <description>Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.</description>
        </group>
        <group group_id="P5">
          <title>Screening Only</title>
          <description>Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Intervention Portion</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="8"/>
                <participants group_id="P5" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="5"/>
                <participants group_id="P5" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Electronic SBIRT (eSBIRT)</title>
          <description>Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.&#xD;
eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.</description>
        </group>
        <group group_id="B2">
          <title>Tailored Texting</title>
          <description>Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.&#xD;
Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
        </group>
        <group group_id="B3">
          <title>eSBIRT &amp; Texting</title>
          <description>Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.&#xD;
eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.&#xD;
Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
        </group>
        <group group_id="B4">
          <title>Assessment Only</title>
          <description>Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.</description>
        </group>
        <group group_id="B5">
          <title>Screening Only</title>
          <description>Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="15"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="15"/>
            <count group_id="B4" value="8"/>
            <count group_id="B5" value="7"/>
            <count group_id="B6" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.3" spread="5.9"/>
                    <measurement group_id="B2" value="23.5" spread="3.7"/>
                    <measurement group_id="B3" value="27.2" spread="5.4"/>
                    <measurement group_id="B4" value="22.6" spread="3.2"/>
                    <measurement group_id="B5" value="NA" spread="NA">Only verified 18 and older during screening. Continuous measure of age asked during assessment.</measurement>
                    <measurement group_id="B6" value="24.6" spread="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="59"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASSIST marijuana score</title>
          <description>The Alcohol Smoking and Substance Involvement Screening Test (ASSIST) was developed by the World Health Organization (WHO) and is used to detect and manage substance use and related problems. For this measure the sum of all the marijuana related items was calculated for each participant. We reported the median score for each intervention arm group. Scores on the marijuana subscale range from 0 to 33. Scores of 0 to 3 present low risk; 4 - 26 moderate risk (at risk of health &amp; other problems from current pattern of use); and 27 - 33 high risk (severe problems &amp; likely to be dependent).</description>
          <units>scores on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9" lower_limit="0" upper_limit="12"/>
                    <measurement group_id="B2" value="9" lower_limit="4" upper_limit="16"/>
                    <measurement group_id="B3" value="6" lower_limit="5" upper_limit="12"/>
                    <measurement group_id="B4" value="6" lower_limit="0.5" upper_limit="11"/>
                    <measurement group_id="B5" value="NA" lower_limit="NA" upper_limit="NA">ASSIST not given during screening</measurement>
                    <measurement group_id="B6" value="8" lower_limit="2" upper_limit="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery</title>
        <description>Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and urine analysis. This will represent the number of participants who abstinent (reported no marijuana use and had a negative toxicology urine screen) from marijuana for the 7 days prior to delivery.</description>
        <time_frame>self-reported use during 7 days prior to delivery of their baby</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electronic SBIRT (eSBIRT)</title>
            <description>Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.&#xD;
eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.</description>
          </group>
          <group group_id="O2">
            <title>Tailored Texting</title>
            <description>Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.&#xD;
Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
          </group>
          <group group_id="O3">
            <title>eSBIRT &amp; Texting</title>
            <description>Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.&#xD;
eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.&#xD;
Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
          </group>
          <group group_id="O4">
            <title>Assessment Only</title>
            <description>Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.</description>
          </group>
          <group group_id="O5">
            <title>Screening Only</title>
            <description>Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery</title>
          <description>Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and urine analysis. This will represent the number of participants who abstinent (reported no marijuana use and had a negative toxicology urine screen) from marijuana for the 7 days prior to delivery.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="7"/>
                <count group_id="O4" value="3"/>
                <count group_id="O5" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery</title>
        <description>Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and hair toxicology analysis. This will represent the number of participants who were abstinent (reported no marijuana use and had a negative hair toxicology results) from marijuana for the 90 days prior to delivery.</description>
        <time_frame>self-reported use during 90 days prior to delivery of their baby</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electronic SBIRT (eSBIRT)</title>
            <description>Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.&#xD;
eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.</description>
          </group>
          <group group_id="O2">
            <title>Tailored Texting</title>
            <description>Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.&#xD;
Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
          </group>
          <group group_id="O3">
            <title>eSBIRT &amp; Texting</title>
            <description>Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.&#xD;
eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.&#xD;
Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
          </group>
          <group group_id="O4">
            <title>Assessment Only</title>
            <description>Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.</description>
          </group>
          <group group_id="O5">
            <title>Screening Only</title>
            <description>Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery</title>
          <description>Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and hair toxicology analysis. This will represent the number of participants who were abstinent (reported no marijuana use and had a negative hair toxicology results) from marijuana for the 90 days prior to delivery.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="2"/>
                <count group_id="O5" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>remainder of the pregnancy (24-20 weeks)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Electronic SBIRT (eSBIRT)</title>
          <description>Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.&#xD;
eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.</description>
        </group>
        <group group_id="E2">
          <title>Tailored Texting</title>
          <description>Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.&#xD;
Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
        </group>
        <group group_id="E3">
          <title>eSBIRT &amp; Texting</title>
          <description>Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.&#xD;
eSBIRT: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.&#xD;
Tailored texting: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.</description>
        </group>
        <group group_id="E4">
          <title>Assessment Only</title>
          <description>Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.</description>
        </group>
        <group group_id="E5">
          <title>Screening Only</title>
          <description>Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="8"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Jessica Beatty</name_or_title>
      <organization>Wayne State University, Merrill Palmer Skillman Institute</organization>
      <phone>3136642518</phone>
      <email>jbeatty@wayne.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02191605
org study id: R34DA036788
secondary id: 1R34DA036788
nct id: NCT02191605
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
Marijuana is by far the mostly commonly used illicit drug during pregnancy, and prenatal
      exposure to marijuana can have lasting negative effects. However, current answers to this
      problem are failing to reach most women who use marijuana while pregnant. This project will
      develop and begin testing two technology-based, highly practical interventions that could
      reduce the number of children who are prenatally exposed to marijuana.
There are at present no evidence-based interventions for marijuana use during pregnancy,
      despite its being by far the most commonly used illicit drug during pregnancy (particularly
      among African-American women), and despite growing evidence that it may have a range of
      long-term cognitive and neurobehavioral consequences. This R34 clinical trial planning grant
      therefore proposes the development and preliminary validation of two high- reach and mutually
      compatible technology-based interventions for marijuana use during pregnancy. The first, a
      theory-based, synchronous, and highly interactive computer-delivered brief intervention, will
      be based on an emerging knowledge base regarding key elements of efficacious
      technology-delivered interventions. The second intervention, a series of tailored text
      messages, will build on the rich literature regarding key tailoring elements. These
      interventions will be developed and refined with input from pregnant women who report active
      use of marijuana, as well as from health care providers. They will subsequently be
      tested-alone and in combination-in a pilot randomized trial involving 80 women actively using
      marijuana during pregnancy. This Stage I pilot work would set the stage for a confirmatory
      Stage II trial. It would also produce the first high-reach brief interventions for marijuana
      use during pregnancy. If effective, these approaches could have a substantial population
      impact on marijuana use among pregnant women, with potential for lifelong improved outcomes
      for both mother and child.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Number of Participants Abstinent From Marijuana for the 7 Days Prior to Delivery
time frame: self-reported use during 7 days prior to delivery of their baby
description: Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and urine analysis. This will represent the number of participants who abstinent (reported no marijuana use and had a negative toxicology urine screen) from marijuana for the 7 days prior to delivery.
measure: Number of Participants Abstinent From Marijuana for the 90 Days Prior to Delivery
time frame: self-reported use during 90 days prior to delivery of their baby
description: Marijuana use will be measured at the time of delivery of their infant by self-report (TimeLine Follow Back interview - TLFB) and hair toxicology analysis. This will represent the number of participants who were abstinent (reported no marijuana use and had a negative hair toxicology results) from marijuana for the 90 days prior to delivery.
arm group label: electronic SBIRT (eSBIRT)
arm group type: Experimental
description: Participants in this condition will receive empathic exploration of their thoughts regarding marijuana use, provision of information on possible consequences of marijuana use during pregnancy and potential benefits of changing use (with permission), normed feedback, use of Motivational Interviewing techniques to elicit their own reasons for change, video testimonials modeling successful change, and information on change methods with optional goal setting.
arm group label: Tailored texting
arm group type: Experimental
description: Participants in this condition will chose the frequency and time of text messages that will continue until childbirth or the participant opts out. The text messages will be a mix of marijuana targeted content (without directly referring to marijuana in a way that implies use by the participant) and general content related to healthy pregnancy; using appropriate humor and tips for community resources. Tailoring will focus on gestational age, self-efficacy, and social support.
arm group label: eSBIRT & texting
arm group type: Experimental
description: Participants in this arm will receive both the computerized intervention and tailored text messaging intervention as described in the eSBIRT and Tailored texting arms.
arm group label: Assessment only
arm group type: No Intervention
description: Participants in the arm will participant in screening and the baseline assessment conducted on the computer only. They will not receive an intervention.
arm group label: Screening only
arm group type: No Intervention
description: Participants in this arm of the study will only answer the screening questions and will not be asked the baseline assessment or participate in an intervention.
intervention type: Behavioral
intervention name: eSBIRT
description: A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.
arm group label: eSBIRT & texting
arm group label: electronic SBIRT (eSBIRT)
intervention type: Behavioral
intervention name: Tailored texting
description: Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.
arm group label: Tailored texting
arm group label: eSBIRT & texting
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Steven J Ondersma, PhD
role: Principal Investigator
affiliation: Wayne State University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wayne State University
investigator full name: Steven J. Ondersma
investigator title: Professor
mesh term: Marijuana Abuse
mesh term: Marijuana Use
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 