<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/NCT03242447</url>
  </required_header>
  <id_info>
    <org_study_id>90AP2679-01-00</org_study_id>
    <nct_id>NCT03242447</nct_id>
  </id_info>
  <brief_title>Evaluation of e-Practice Self-Regulation (e-PS-R)</brief_title>
  <official_title>Evaluation of e-Practice Self-Regulation (e-PS-R)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Policy &amp; Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Health and Human Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>The Policy &amp; Research Group</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>
      The purpose of the study is to determine the impact of the offer to participate in the&#xD;
      e-Practice Self-Regulation (e-PS-R) (treatment) relative to the control condition on&#xD;
      increasing knowledge of sexual health and the impact of trauma on sexual decision-making and&#xD;
      preventing teen pregnancy and high-risk behaviors 12 months after enrollment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Policy &amp; Research Group (PRG) will be conducting a rigorous evaluation of an innovative&#xD;
      intervention designed to prevent adolescent pregnancy, births, and STIs among high-risk youth&#xD;
      populations, entitled online Practice Self-Regulation (e-PS-R). e-PS-R is the online&#xD;
      adaptation of the Practice Self-Regulation (PS-R); both PS-R and e-PS-R were developed&#xD;
      through grant funding by Joann Schladale of Resources for Resolving Violence, Inc. The&#xD;
      original PS-R intervention is a 10-session therapeutic program designed for youth ages 14-19&#xD;
      who have experienced trauma; each session is intended to be offered by a masters-level&#xD;
      therapist during one-on-one weekly therapy sessions. The online adaptation e-PS-R utilizes&#xD;
      'blended learning', the combination of online and face-to-face instruction, and incorporates&#xD;
      online videos and interactive elements that have been shown to be effective with high-risk&#xD;
      youth. e-PS-R consists of eight 30-minute e-learning sessions for youth participants and four&#xD;
      30-45 minute one-on-one in-person meetings between youth and a trained facilitator. The&#xD;
      following Adulthood Preparation Subjects are covered during both the online sessions and the&#xD;
      in-person meetings: Adolescent Development, Healthy Life Skills, and Healthy Relationships.&#xD;
      By increasing knowledge of sexual health and the impact of trauma on sexual decision-making,&#xD;
      the program is designed to encourage and support youth in practicing self-regulation.&#xD;
&#xD;
      The Policy &amp; Research Group (PRG) will conduct an implementation evaluation and an impact&#xD;
      evaluation, using a randomized controlled trial, to test the effectiveness of this new&#xD;
      intervention. The study will target juvenile justice-involved youth ages 14-19 who have&#xD;
      experienced trauma. The primary focus of the study will be to investigate the impact of the&#xD;
      intervention on two self-reported sexual behaviors: (1) inconsistency of condom use, and (2)&#xD;
      number of sexual partners. In addition, the study will include exploratory investigations of&#xD;
      the following self-reported sexual behaviors and theoretically relevant antecedents to&#xD;
      behavior and pathways to behavior change: (1) use of contraception; (2) use of dual methods&#xD;
      of protection; (3) incidence of pregnancy; (4) self-efficacy to engage in affect regulation;&#xD;
      (5) sexual self-efficacy; (6) intentions to engage in affect-regulation; (7) intentions to&#xD;
      engage in sexual self-regulation; and (8) use of affect regulation. Outcomes will be assessed&#xD;
      using self-reported, participant-level data gathered (by way of a questionnaire) at four time&#xD;
      points: baseline (enrollment); post-program (immediately after the end of the intervention&#xD;
      period; 3 months after baseline); short-term (3 months post-intervention period) follow-up;&#xD;
      and long-term (nine months post-intervention period) follow-up.&#xD;
&#xD;
      Starting in July 2017 and continuing for two years, 600 participants will be enrolled into&#xD;
      the study at partner implementation sites within the juvenile justice systems in New Mexico&#xD;
      and West Virginia. The third and fourth years of the grant will be used to complete the&#xD;
      following tasks: collect follow-up data from study participants; conduct implementation and&#xD;
      impact evaluation analysis, reporting, and dissemination efforts; and manualize and package&#xD;
      the curriculum and training materials.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2, 2017</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">April 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>
    <intervention_model_description>participants are assigned to one of two or more groups in parallel for the duration of the study</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>participants' self-reported sexual behaviors</measure>
    <time_frame>12 months after enrollment into the study</time_frame>
    <description>The primary outcome will be the mean differences between the treatment and control group participants in self-reported sexual behaviors at 12-month follow-up; exploratory analyses will examine differences in sexual behaviors post-program and differences in other theoretically relevant outcomes (e.g., attitudes, self-efficacies, self-regulatory behaviors) at both post-program and 12-month follow-up.&#xD;
The independent variable of interest will be the treatment assignment, which will be operationalized as being randomly assigned to the active treatment (1) or the control condition (0).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>consistency of contraceptive use</measure>
    <time_frame>12 months after enrollment</time_frame>
    <description>The risk outcome is operationalized as the proportion of times a person reports having sexual intercourse without using any form of birth control (including condoms). The measure is calculated from the following items:&#xD;
The measure is calculated by dividing the total number of times a person reported having sexual intercourse without using any contraception by the total number of times she reported having sexual intercourse.&#xD;
The resulting variable is a continuous proportion with values that range from 0 to 1, where 0 indicates that a person has not engaged in sexual intercourse without birth control in the past three months, and 1 indicates that the person has engaged in sexual intercourse without birth control (risk behavior) 100% of the times they had sex in the past three months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>frequency of sexual activity</measure>
    <time_frame>12 months after enrollment</time_frame>
    <description>The risk outcome is operationalized as the number of times in the past three months a person reports having any type of sex.&#xD;
The measure is taken directly from the following item:&#xD;
• In total, how many times have you had any type of sex in the past 3 months?&#xD;
The variable is continuous, with values ranging from 0 to k, where 0= no sexual activity reported in past 3 months and k = number of times sex reported.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">631</enrollment>
  <condition>Teen Pregnancy Prevention</condition>
  <arm_group>
    <arm_group_label>e-Practice Self-Regulation (e-PS-R)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>e-Practice Self-Regulation (e-PSR) is the treatment condition. e-PS-R is a 'blended learning' intervention, combining online and face-to-face instruction. e-PS-R aims to increase knowledge of sexual health and the impact of trauma on sexual decision-making.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Video Health Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Video Health Group is the control counterfactual condition. Youth assigned to the control group will view a video on a non-sexual health topic (the hazards of smoking).The video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes. The informational video uses both narration and interviews to educate viewers on the dangers that cigarettes pose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>e-Practice Self-Regulation</intervention_name>
    <description>e-PS-R utilizes 'blended learning', the combination of online and face-to-face instruction, and incorporates online videos and interactive elements that have been shown to be effective with high-risk youth. e-PS-R consists of eight 30-minute e-learning sessions for youth participants and four 30-45 minute one-on-one in-person meetings between youth and a trained facilitator.</description>
    <arm_group_label>e-Practice Self-Regulation (e-PS-R)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Video Health Group</intervention_name>
    <description>The video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes.</description>
    <arm_group_label>Video Health Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be aged 14-19&#xD;
&#xD;
          -  Be involved with the juvenile justice system&#xD;
&#xD;
          -  Be deemed appropriate for study by site staff and study facilitator (no acute illness&#xD;
             or behavioral problems; psychiatrically stable; cognitively capable of internalizing&#xD;
             and comprehending content of intervention)&#xD;
&#xD;
          -  Possess adequate English-language comprehension (be able to read and comprehend the&#xD;
             on-line intervention materials, which are available only in English)&#xD;
&#xD;
          -  Consent/assent to participating in study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not be residing in or scheduled to enter a secure facility&#xD;
&#xD;
          -  Not be currently pregnant&#xD;
&#xD;
          -  Not be trying to get pregnant&#xD;
&#xD;
          -  Not be an enrolled participant (former or current) in the Teen Health Study (Teen&#xD;
             Pregnancy Prevention study funded by the Office of Adolescent Health, being conducted&#xD;
             in Albuquerque, New Mexico)&#xD;
&#xD;
          -  Not have previously participated in e-PS-R&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Jenner, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Policy &amp; Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Policy &amp; Research Group</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>December 8, 2022</last_update_submitted>
  <last_update_submitted_qc>December 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program sessions were attended). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.</ipd_description>
    <ipd_time_frame>The individual participant dataset will become available twelve months after the study has concluded.</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03242447
org study id: 90AP2679-01-00
nct id: NCT03242447
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to determine the impact of the offer to participate in the
      e-Practice Self-Regulation (e-PS-R) (treatment) relative to the control condition on
      increasing knowledge of sexual health and the impact of trauma on sexual decision-making and
      preventing teen pregnancy and high-risk behaviors 12 months after enrollment.
The Policy & Research Group (PRG) will be conducting a rigorous evaluation of an innovative
      intervention designed to prevent adolescent pregnancy, births, and STIs among high-risk youth
      populations, entitled online Practice Self-Regulation (e-PS-R). e-PS-R is the online
      adaptation of the Practice Self-Regulation (PS-R); both PS-R and e-PS-R were developed
      through grant funding by Joann Schladale of Resources for Resolving Violence, Inc. The
      original PS-R intervention is a 10-session therapeutic program designed for youth ages 14-19
      who have experienced trauma; each session is intended to be offered by a masters-level
      therapist during one-on-one weekly therapy sessions. The online adaptation e-PS-R utilizes
      'blended learning', the combination of online and face-to-face instruction, and incorporates
      online videos and interactive elements that have been shown to be effective with high-risk
      youth. e-PS-R consists of eight 30-minute e-learning sessions for youth participants and four
      30-45 minute one-on-one in-person meetings between youth and a trained facilitator. The
      following Adulthood Preparation Subjects are covered during both the online sessions and the
      in-person meetings: Adolescent Development, Healthy Life Skills, and Healthy Relationships.
      By increasing knowledge of sexual health and the impact of trauma on sexual decision-making,
      the program is designed to encourage and support youth in practicing self-regulation.

      The Policy & Research Group (PRG) will conduct an implementation evaluation and an impact
      evaluation, using a randomized controlled trial, to test the effectiveness of this new
      intervention. The study will target juvenile justice-involved youth ages 14-19 who have
      experienced trauma. The primary focus of the study will be to investigate the impact of the
      intervention on two self-reported sexual behaviors: (1) inconsistency of condom use, and (2)
      number of sexual partners. In addition, the study will include exploratory investigations of
      the following self-reported sexual behaviors and theoretically relevant antecedents to
      behavior and pathways to behavior change: (1) use of contraception; (2) use of dual methods
      of protection; (3) incidence of pregnancy; (4) self-efficacy to engage in affect regulation;
      (5) sexual self-efficacy; (6) intentions to engage in affect-regulation; (7) intentions to
      engage in sexual self-regulation; and (8) use of affect regulation. Outcomes will be assessed
      using self-reported, participant-level data gathered (by way of a questionnaire) at four time
      points: baseline (enrollment); post-program (immediately after the end of the intervention
      period; 3 months after baseline); short-term (3 months post-intervention period) follow-up;
      and long-term (nine months post-intervention period) follow-up.

      Starting in July 2017 and continuing for two years, 600 participants will be enrolled into
      the study at partner implementation sites within the juvenile justice systems in New Mexico
      and West Virginia. The third and fourth years of the grant will be used to complete the
      following tasks: collect follow-up data from study participants; conduct implementation and
      impact evaluation analysis, reporting, and dissemination efforts; and manualize and package
      the curriculum and training materials.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: participants are assigned to one of two or more groups in parallel for the duration of the study
primary purpose: Prevention
masking: None (Open Label)
measure: participants' self-reported sexual behaviors
time frame: 12 months after enrollment into the study
description: The primary outcome will be the mean differences between the treatment and control group participants in self-reported sexual behaviors at 12-month follow-up; exploratory analyses will examine differences in sexual behaviors post-program and differences in other theoretically relevant outcomes (e.g., attitudes, self-efficacies, self-regulatory behaviors) at both post-program and 12-month follow-up.
The independent variable of interest will be the treatment assignment, which will be operationalized as being randomly assigned to the active treatment (1) or the control condition (0).
measure: consistency of contraceptive use
time frame: 12 months after enrollment
description: The risk outcome is operationalized as the proportion of times a person reports having sexual intercourse without using any form of birth control (including condoms). The measure is calculated from the following items:
The measure is calculated by dividing the total number of times a person reported having sexual intercourse without using any contraception by the total number of times she reported having sexual intercourse.
The resulting variable is a continuous proportion with values that range from 0 to 1, where 0 indicates that a person has not engaged in sexual intercourse without birth control in the past three months, and 1 indicates that the person has engaged in sexual intercourse without birth control (risk behavior) 100% of the times they had sex in the past three months.
measure: frequency of sexual activity
time frame: 12 months after enrollment
description: The risk outcome is operationalized as the number of times in the past three months a person reports having any type of sex.
The measure is taken directly from the following item:
• In total, how many times have you had any type of sex in the past 3 months?
The variable is continuous, with values ranging from 0 to k, where 0= no sexual activity reported in past 3 months and k = number of times sex reported.
arm group label: e-Practice Self-Regulation (e-PS-R)
arm group type: Experimental
description: e-Practice Self-Regulation (e-PSR) is the treatment condition. e-PS-R is a 'blended learning' intervention, combining online and face-to-face instruction. e-PS-R aims to increase knowledge of sexual health and the impact of trauma on sexual decision-making.
arm group label: Video Health Group
arm group type: Active Comparator
description: The Video Health Group is the control counterfactual condition. Youth assigned to the control group will view a video on a non-sexual health topic (the hazards of smoking).The video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes. The informational video uses both narration and interviews to educate viewers on the dangers that cigarettes pose.
intervention type: Behavioral
intervention name: e-Practice Self-Regulation
description: e-PS-R utilizes 'blended learning', the combination of online and face-to-face instruction, and incorporates online videos and interactive elements that have been shown to be effective with high-risk youth. e-PS-R consists of eight 30-minute e-learning sessions for youth participants and four 30-45 minute one-on-one in-person meetings between youth and a trained facilitator.
arm group label: e-Practice Self-Regulation (e-PS-R)
intervention type: Behavioral
intervention name: Video Health Group
description: The video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes.
arm group label: Video Health Group
criteria: 
gender: All
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: No
last name: Eric Jenner, PhD
role: Principal Investigator
affiliation: The Policy & Research Group
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program sessions were attended). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.
ipd time frame: The individual participant dataset will become available twelve months after the study has concluded.