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A Healthy Relationships Program for Vulnerable Youth

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ClinicalTrials.gov Identifier: NCT03736876
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
Family and Youth Services Bureau
San Diego State University
California School-Based Health Alliance
Information provided by (Responsible Party):
ETR Associates

Brief Summary:

Developed from a piloted intervention and based on scientific evidence, About Us is an innovative healthy relationships intervention that promotes positive adolescent romantic relationships and use of condoms and highly effective contraceptives if having sex. The program includes 10 lessons (2 that are between 30-45 minutes long 8 that are 50 minutes long) that blend group-based activities with online activities implemented in a small group format with students in grades 9 or 10 who have parental consent and provide assent to take part. The program will be implemented in school-based health centers (SBHCs).

Primary research question:

  1. Nine months following the end of the program, what is the impact of About Us relative to the standard of care on:

    1.1. Rates of vaginal or anal sex without condoms in the past three months?

    Secondary research questions:

  2. Three and nine months following the end of the program, what is the impact of About Us relative to the standard of care on:

    2.1. Rates of abstinence from vaginal or anal sex in the past three months? 2.2. Frequency of communicating without abuse? 2.3. Utilization of school-based health center services? 2.4. Rates of behavioral willingness and attitudes toward birth control?

    Exploratory research questions:

  3. Three and nine months following the end of the program, what is the impact of About Us relative to the standard of care on:

    3.1. The psychosocial variables stemming from the theoretical framework (e.g., attitudes toward condom and contraceptive use, normative beliefs, perceived self-efficacy to use condoms or have difficult conversations) and enumerated in the logic model.

    3.2. Outcomes listed above within key sub-groups including those defined by sex (male/female), race/ethnicity, and exposure to violence;

  4. Among those receiving About Us, how do effect sizes for the primary and secondary behavioral outcomes vary by dosage?

Condition or disease Intervention/treatment Phase
Pregnancy, Unplanned Sexually Transmitted Diseases Behavioral: About Us Not Applicable

Detailed Description:
Students will be screened for eligibility through each school-based health center (SBHC) by SBHC staff, and those participants meeting the screening eligibility requirements (previous exposure to violence and/or previous or current involvement in a romantic relationship) will be offered a parental consent form and informational packet. Consent forms will be available in English and Spanish. Pending parental consent and youth assent, students will be randomized into either the intervention or control group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1209 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multi-site independent randomized group treatment trial (IGRT). 1,209 youth randomized to intervention or control conditions within schools. Sample accrues over 2.5 years (Years 2-4)
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: About Us: A Healthy Relationships Program for Vulnerable Youth
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment group
These students will receive About Us, an innovative, healthy relationship intervention. The program includes 10 lessons that blend group-based activities with online activities implemented in school-based health centers.
Behavioral: About Us
Each program session includes an initial soap opera-like story to build interest and illustrate key concepts, 2-3 group-based activities with reflection, individual app-based work on tablets to allow for personalization of the content, and a group-based debrief to reflect on the day and reinforce key messages. The group-based content is delivered by trained facilitators from the participating school-based health centers. The app-based content is housed on a secure website and accessed through tablets with unique log-ins for each participant. Activities are completed individually during the session (e.g., completing a poll; watching and responding to a brief video). Several lessons include homework activities that encourage communication between students and a caring adult.

No Intervention: Delayed intervention (control group)
These students will receive the business-as--usual condition (e.g., the standard health education that is provided by the school during the study period), and will receive the intervention once the study period has concluded.



Primary Outcome Measures :
  1. Rates of vaginal or anal sex without condoms [ Time Frame: 9 months post intervention ]
    Number of times reported having vaginal or anal sex without using condoms or insertive condoms in the past 3 months


Secondary Outcome Measures :
  1. Rates of abstinence of vaginal or anal sex [ Time Frame: 3 months post intervention ]
    Number of times reported having vaginal or anal intercourse

  2. Rates of abstinence of vaginal or anal sex [ Time Frame: 9 months post intervention ]
    Number of times reported having vaginal or anal intercourse

  3. Frequency of communicating without abuse [ Time Frame: 3 months post intervention ]
    Number of times reported communicating with a partner without abuse

  4. Frequency of communicating without abuse [ Time Frame: 9 months post intervention ]
    Number of times reported communicating with a partner without abuse

  5. Clinic utilization [ Time Frame: 3 months post intervention ]
    Number of times receiving services or information from school-based health center on contraception, pregnancy, abortion, or sexually transmitted diseases

  6. Clinic utilization [ Time Frame: 9 months post intervention ]
    Number of times receiving services or information from school-based health center on contraception, pregnancy, abortion, or sexually transmitted diseases.

  7. Behavioral intentions to engage in sexual activity [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, general willingness or likelihood to engage in vaginal or anal sex if given the chance.

  8. Behavioral intentions to engage in sexual activity [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, general willingness or likelihood to engage in vaginal or anal sex if given the chance.

  9. Behavioral intentions to use condoms [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, general willingness or likelihood to use condoms when engaging in vaginal or anal sex.

  10. Behavioral intentions to use condoms [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, general willingness or likelihood to use condoms when engaging in vaginal or anal sex.


Other Outcome Measures:
  1. Sexual consent attitudes [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, overall agreement or disagreement towards communicating verbal and nonverbal willingness to engage in sexual activity.

  2. Sexual consent attitudes [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, overall agreement or disagreement towards communicating verbal and nonverbal willingness to engage in sexual activity.

  3. Sexual boundaries attitudes [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, positive or negative attitudes towards respecting a partner's stated sexual boundaries.

  4. Sexual boundaries attitudes [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, positive or negative attitudes towards respecting a partner's stated sexual boundaries.

  5. Intimate relationship attitudes [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, overall agreement or disagreement with romantic relationship satisfaction with a current or most recent partner.

  6. Intimate relationship attitudes [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, overall agreement or disagreement with romantic relationship satisfaction with a current or most recent partner.

  7. Non-abusive relationship attitudes [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, perceived level of efficacy and comfort with managing conflict in a romantic relationship.

  8. Non-abusive relationship attitudes [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, perceived level of efficacy and comfort with managing conflict in a romantic relationship.

  9. Condom use attitudes [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, overall agreement or disagreement towards condom use attitudes in five areas - a) reliability and effectiveness of condoms; b) sexual pleasure associated with condom use; c) stigma for or against condom use; d) embarrassment about negotiating and using condoms; and, e) embarrassment about purchasing condoms.

  10. Condom use attitudes [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, overall agreement or disagreement towards condom use attitudes in five areas - a) reliability and effectiveness of condoms; b) sexual pleasure associated with condom use; c) stigma for or against condom use; d) embarrassment about negotiating and using condoms; and, e) embarrassment about purchasing condoms.

  11. Contraceptive use attitudes [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, overall agreement or disagreement towards using contraceptives in general as opposed to specific methods.

  12. Contraceptive use attitudes [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, overall agreement or disagreement towards using contraceptives in general as opposed to specific methods.

  13. Peer normative beliefs about condom use [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, the extent to which respondents perceived their peers used condoms every time they had sex.

  14. Peer normative beliefs about condom use [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, the extent to which respondents perceived their peers used condoms every time they had sex.

  15. Condom use negotiation self-efficacy [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, overall agreement or disagreement with barriers associated with negotiating condom use with a partner.

  16. Condom use negotiation self-efficacy [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, overall agreement or disagreement with barriers associated with negotiating condom use with a partner.

  17. Communicating without abuse self-efficacy [ Time Frame: 3 months post intervention ]
    Using two sub-scales (verbal-emotional abuse and conflict resolution) from the CADRI (Conflict in Adolescent Dating Relationships Inventory), respondents perceived efficacy to communicate with a partner during a conflict or an argument in non-abusive ways.

  18. Communicating without abuse self-efficacy [ Time Frame: 9 months post intervention ]
    Using two sub-scales (verbal-emotional abuse and conflict resolution) from the CADRI (Conflict in Adolescent Dating Relationships Inventory), respondents perceived efficacy to communicate with a partner during a conflict or an argument in non-abusive ways.

  19. Condom use self-efficacy [ Time Frame: 3 months post intervention ]
    Using a Likert-type scale, respondents perceived efficacy to apply and remove condoms correctly and consistently.

  20. Condom use self-efficacy [ Time Frame: 9 months post intervention ]
    Using a Likert-type scale, respondents perceived efficacy to apply and remove condoms correctly and consistently.

  21. Condom use skills [ Time Frame: 3 months post intervention ]
    Count of the number of condom steps skills answered correctly

  22. Condom use skills [ Time Frame: 9 months post intervention ]
    Count of the number of condom steps skills answered correctly



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The target population includes 9th or 10th grade students from participating schools who meet at least one of the following inclusion criteria based on their responses to a school-wide health assessment:

    1. prior exposure to violence;
    2. prior or current experience with a romantic relationship.

Any student answering "yes" to either criteria would be eligible to take part in the study. Only those who have parent consent and assent would be enrolled.

Exclusion Criteria:

  • Those students without parental consent;
  • If siblings are eligible to participate, the sibling who returns the signed consent form first will be admitted into the study. Any other eligible siblings will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03736876


Contacts
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Contact: Pamela M Anderson, PhD 831-440-2132 pamela.anderson@etr.org
Contact: Stephanie Guinosso, PhD MPH 510-858-0994 stephanie.guinosso@etr.org

Locations
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United States, California
California School Based Health Alliance Recruiting
Oakland, California, United States, 94612
Contact: Amy Manta-Ranger    510-350-3290    aranger@schoolhealthcenters.org   
San Diego State University Recruiting
San Diego, California, United States, 92182
Contact: Eric Walsh-Buhi, MPH PhD    619-594-7058    ebuhi@sdsu.edu   
Contact: Emily Greenstadt, MPH       egreenstadt@sdsu.edu   
Sub-Investigator: Eric Walsh-Buhi, MPH PhD         
ETR Recruiting
Scotts Valley, California, United States, 95066
Contact: Stephanie Guinosso, PhD MPH    510-858-0994    stephanie.guinosso@etr.org   
Contact: Pamela M Anderson, PhD    831-440-2132    pamela.anderson@etr.org   
Principal Investigator: Karin K Coyle, PhD         
Principal Investigator: Pamela M Anderson, PhD         
Sponsors and Collaborators
ETR Associates
Family and Youth Services Bureau
San Diego State University
California School-Based Health Alliance
Investigators
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Principal Investigator: Karin K Coyle, PhD ETR
Principal Investigator: Pamela M Anderson, PhD ETR

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Responsible Party: ETR Associates
ClinicalTrials.gov Identifier: NCT03736876     History of Changes
Other Study ID Numbers: 90 AP2682-01-00
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: As part of our commitment to data security and confidentiality, IPD will not be shared outside the research team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ETR Associates:
Sexually Transmitted Infections
Sexually Transmitted Diseases
Sexual Health Education
Youth
Adolescents
Teens
Healthy Relationships
Unintended Pregnancy
Teen Pregnancy
School-Based Health Center
Randomized Controlled Trial

Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female