<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/NCT01678378</url>
  </required_header>
  <id_info>
    <org_study_id>12020646</org_study_id>
    <nct_id>NCT01678378</nct_id>
  </id_info>
  <brief_title>School Health Center Healthy Adolescent Relationship Program</brief_title>
  <acronym>SHARP</acronym>
  <official_title>School Health Center Healthy Adolescent Relationship Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This community-partnered participatory study will work within high school health centers&#xD;
      (SHCs) to test, via a 2-armed cluster randomized controlled trial, a multi-level intervention&#xD;
      to reduce adolescent relationship abuse (ARA) among adolescents ages 14-19. The goal of this&#xD;
      study is to examine the effectiveness of the School Health Center Healthy Adolescent&#xD;
      Relationships Program (SHARP) intervention in SHCs on individual SHC clients, the SHC clinic&#xD;
      environment, and the schools in which the SHCs are located. Evaluation of the intervention&#xD;
      will involve random assignment of eight comparable SHCs in the Greater Bay Area of California&#xD;
      that provide comprehensive health services, to either intervention or control sites.&#xD;
      Adolescent females and males ages 14-19 seeking care at any of these SHCs (N=1200) will be&#xD;
      assessed via audio computer-assisted survey instrument (ACASI) at baseline and 16-20 weeks&#xD;
      follow-up to examine intervention effects on knowledge and self-efficacy regarding ARA, harm&#xD;
      reduction and ARA-related resources as well as intentions to intervene with peers. For youth&#xD;
      reporting recent ARA victimization, the investigators will assess for increases in ARA&#xD;
      disclosure, resource utilization, as well as reduction in ARA victimization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recognition of adolescent relationship abuse</measure>
    <time_frame>4 months</time_frame>
    <description>&quot;Recognition of abusive behaviors&quot; -- Between-arm adjusted mean differences on a 9-item summary scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intentions to positively intervene in adolescent relationship abuse among peers</measure>
    <time_frame>4 months</time_frame>
    <description>&quot;Intentions to intervene&quot; -- Between-arm adjusted mean differences on a 9-item summary scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Knowledge of violence victimization resources</measure>
    <time_frame>4 months</time_frame>
    <description>&quot;Knowledge of resources&quot; -- Between arm differences of summary score of single items which assess the extent to which participants are aware of places they could go for specific support services.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disclosure of adolescent relationship abuse to school health center providers</measure>
    <time_frame>baseline (after clinic visit)</time_frame>
    <description>Between-arm adjusted differences in proportion disclosing adolescent relationship abuse (ARA) to school health providers at baseline. Comparisons restricted to subgroup of clients reporting ARA on ACASI survey at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uptake of adolescent relationship abuse harm reduction and utilization of resources</measure>
    <time_frame>4 months</time_frame>
    <description>Between-arm adjusted differences in proportion reporting any use of ARA resources in the 3-month period prior to the follow-up survey. Comparisons restricted to clients reporting ARA on ACASI survey at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adolescent relationship abuse victimization</measure>
    <time_frame>4 months</time_frame>
    <description>Between-arm adjusted differences in proportion screened positive for at least one adolescent relationship abuse (ARA) behavior, based on screening tests for reproductive coercion, intimate partner and sexual violence victimization and psychological abuse. Comparisons restricted to clients reporting ARA at baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of harm reduction strategies</measure>
    <time_frame>4 months</time_frame>
    <description>Participants are presented with a series of harm reduction behaviors to reduce risk for ARA, and asked to what extent they are aware of these strategies and self-efficacy in enacting these behaviors based on a 7-point Likert-type scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1012</enrollment>
  <condition>Adolescent Relationship Abuse</condition>
  <arm_group>
    <arm_group_label>SHARP Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>School health centers randomized to the SHARP Intervention will be trained to address adolescent relationship abuse with school health center clients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>School health centers randomized to Control will provide standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SHARP Intervention</intervention_name>
    <description>Providers and staff located in high school school health centers (i.e., nurse practitioners, nurses,physicians, health educators, medical assistants) will be trained to address adolescent relationship abuse with school health center clients using knowledge, skills, and resources gained through the SHARP Intervention training. The training includes strategies to help youth recognize adolescent relationship abuse among themselves and their peers, to learn strategies to increase safety (harm reduction), and to utilize adolescent relationship abuse-related resources.</description>
    <arm_group_label>SHARP Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 14-19&#xD;
&#xD;
          -  receiving services at one of the eight SHARP Intervention school health centers&#xD;
&#xD;
          -  able to read English or Spanish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clients not of the specified age range&#xD;
&#xD;
          -  clients who are intoxicated or otherwise not able to provide their own consent&#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>Sandi Goldstein</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pubic Health Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth Miller, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Public Health Institute</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncjrs.gov/pdffiles1/nij/grants/248640.pdf</url>
    <description>U.S. Department of Justice Final Report</description>
  </link>
  <results_reference>
    <citation>Miller E, Goldstein S, McCauley HL, Jones KA, Dick RN, Jetton J, Silverman JG, Blackburn S, Monasterio E, James L, Tancredi DJ. A school health center intervention for abusive adolescent relationships: a cluster RCT. Pediatrics. 2015 Jan;135(1):76-85. doi: 10.1542/peds.2014-2471. Epub 2014 Dec 22.</citation>
    <PMID>25535265</PMID>
  </results_reference>
  <results_reference>
    <citation>Dick RN, McCauley HL, Jones KA, Tancredi DJ, Goldstein S, Blackburn S, Monasterio E, James L, Silverman JG, Miller E. Cyber dating abuse among teens using school-based health centers. Pediatrics. 2014 Dec;134(6):e1560-7. doi: 10.1542/peds.2014-0537. Epub 2014 Nov 17.</citation>
    <PMID>25404724</PMID>
  </results_reference>
  <results_reference>
    <citation>McCauley HL, Dick RN, Tancredi DJ, Goldstein S, Blackburn S, Silverman JG, Monasterio E, James L, Miller E. Differences by sexual minority status in relationship abuse and sexual and reproductive health among adolescent females. J Adolesc Health. 2014 Nov;55(5):652-8. doi: 10.1016/j.jadohealth.2014.04.020. Epub 2014 Jun 21.</citation>
    <PMID>24962502</PMID>
  </results_reference>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>September 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>April 24, 2015</last_update_submitted>
  <last_update_submitted_qc>April 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 27, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adolescent</keyword>
  <keyword>Intervention</keyword>
  <keyword>Female</keyword>
  <keyword>Male</keyword>
  <keyword>Interpersonal Relations</keyword>
  <keyword>School Health Services</keyword>
  <keyword>Community-Based Participatory Research</keyword>
  <keyword>Randomized Controlled Trial</keyword>
  <keyword>Health Care Provider</keyword>
  <keyword>Training Program</keyword>
  <keyword>Harm Reduction</keyword>
  <keyword>Prevention</keyword>
  <keyword>Reproductive Coercion</keyword>
  <keyword>Tech-Based Abuse</keyword>
  <keyword>Social Environment</keyword>
  <keyword>Sexual Partners</keyword>
  <!-- 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/NCT01678378
org study id: 12020646
nct id: NCT01678378
lead sponsor: 
has dmc: Yes
This community-partnered participatory study will work within high school health centers
      (SHCs) to test, via a 2-armed cluster randomized controlled trial, a multi-level intervention
      to reduce adolescent relationship abuse (ARA) among adolescents ages 14-19. The goal of this
      study is to examine the effectiveness of the School Health Center Healthy Adolescent
      Relationships Program (SHARP) intervention in SHCs on individual SHC clients, the SHC clinic
      environment, and the schools in which the SHCs are located. Evaluation of the intervention
      will involve random assignment of eight comparable SHCs in the Greater Bay Area of California
      that provide comprehensive health services, to either intervention or control sites.
      Adolescent females and males ages 14-19 seeking care at any of these SHCs (N=1200) will be
      assessed via audio computer-assisted survey instrument (ACASI) at baseline and 16-20 weeks
      follow-up to examine intervention effects on knowledge and self-efficacy regarding ARA, harm
      reduction and ARA-related resources as well as intentions to intervene with peers. For youth
      reporting recent ARA victimization, the investigators will assess for increases in ARA
      disclosure, resource utilization, as well as reduction in ARA victimization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Recognition of adolescent relationship abuse
time frame: 4 months
description: "Recognition of abusive behaviors" -- Between-arm adjusted mean differences on a 9-item summary scale
measure: Intentions to positively intervene in adolescent relationship abuse among peers
time frame: 4 months
description: "Intentions to intervene" -- Between-arm adjusted mean differences on a 9-item summary scale
measure: Knowledge of violence victimization resources
time frame: 4 months
description: "Knowledge of resources" -- Between arm differences of summary score of single items which assess the extent to which participants are aware of places they could go for specific support services.
measure: Disclosure of adolescent relationship abuse to school health center providers
time frame: baseline (after clinic visit)
description: Between-arm adjusted differences in proportion disclosing adolescent relationship abuse (ARA) to school health providers at baseline. Comparisons restricted to subgroup of clients reporting ARA on ACASI survey at baseline.
measure: Uptake of adolescent relationship abuse harm reduction and utilization of resources
time frame: 4 months
description: Between-arm adjusted differences in proportion reporting any use of ARA resources in the 3-month period prior to the follow-up survey. Comparisons restricted to clients reporting ARA on ACASI survey at baseline.
measure: Adolescent relationship abuse victimization
time frame: 4 months
description: Between-arm adjusted differences in proportion screened positive for at least one adolescent relationship abuse (ARA) behavior, based on screening tests for reproductive coercion, intimate partner and sexual violence victimization and psychological abuse. Comparisons restricted to clients reporting ARA at baseline.
measure: Knowledge of harm reduction strategies
time frame: 4 months
description: Participants are presented with a series of harm reduction behaviors to reduce risk for ARA, and asked to what extent they are aware of these strategies and self-efficacy in enacting these behaviors based on a 7-point Likert-type scale
arm group label: SHARP Intervention
arm group type: Experimental
description: School health centers randomized to the SHARP Intervention will be trained to address adolescent relationship abuse with school health center clients.
arm group label: Control
arm group type: No Intervention
description: School health centers randomized to Control will provide standard of care.
intervention type: Behavioral
intervention name: SHARP Intervention
description: Providers and staff located in high school school health centers (i.e., nurse practitioners, nurses,physicians, health educators, medical assistants) will be trained to address adolescent relationship abuse with school health center clients using knowledge, skills, and resources gained through the SHARP Intervention training. The training includes strategies to help youth recognize adolescent relationship abuse among themselves and their peers, to learn strategies to increase safety (harm reduction), and to utilize adolescent relationship abuse-related resources.
arm group label: SHARP Intervention
criteria: 
gender: All
minimum age: 14 Years
maximum age: 19 Years
healthy volunteers: No
last name: Sandi Goldstein
role: Principal Investigator
affiliation: Pubic Health Institute
last name: Elizabeth Miller, MD, PhD
role: Principal Investigator
affiliation: University of Pittsburgh, Children's Hospital of Pittsburgh of UPMC
facility: 
country: United States
url: https://www.ncjrs.gov/pdffiles1/nij/grants/248640.pdf
description: U.S. Department of Justice Final Report
citation: Miller E, Goldstein S, McCauley HL, Jones KA, Dick RN, Jetton J, Silverman JG, Blackburn S, Monasterio E, James L, Tancredi DJ. A school health center intervention for abusive adolescent relationships: a cluster RCT. Pediatrics. 2015 Jan;135(1):76-85. doi: 10.1542/peds.2014-2471. Epub 2014 Dec 22.
PMID: 25535265
citation: Dick RN, McCauley HL, Jones KA, Tancredi DJ, Goldstein S, Blackburn S, Monasterio E, James L, Silverman JG, Miller E. Cyber dating abuse among teens using school-based health centers. Pediatrics. 2014 Dec;134(6):e1560-7. doi: 10.1542/peds.2014-0537. Epub 2014 Nov 17.
PMID: 25404724
citation: McCauley HL, Dick RN, Tancredi DJ, Goldstein S, Blackburn S, Silverman JG, Monasterio E, James L, Miller E. Differences by sexual minority status in relationship abuse and sexual and reproductive health among adolescent females. J Adolesc Health. 2014 Nov;55(5):652-8. doi: 10.1016/j.jadohealth.2014.04.020. Epub 2014 Jun 21.
PMID: 24962502
responsible party type: Sponsor