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Active Not Recruiting INTERVENTIONAL NCT05889689

Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters

Relationship Smarts Plus and Mind Matters: A Randomized Control Trial of a Youth Intervention to Reduce Sexual Risk Behaviors.

Sponsor: AMTC & Associates

Updated 6 times since 2023 Last updated: Apr 25, 2026 Started: Sep 23, 2023 Primary completion: Apr 30, 2026 Completion: Apr 30, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05889689, this observational or N/A phase trial focuses on Contraception Behavior and Reproductive Health and remains ongoing. Sponsored by AMTC & Associates, it has been updated 6 times since 2023, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

The intervention combines the pregnancy prevention curriculum, Relationship Smarts Plus (RSP+) with lessons from the trauma coping skills curriculum, Mind Matters (MM). The mental health component was added to assess the importance of mental health as a risk factor for teen pregnancy. Researchers will estimate the effect of Mind Matters (MM) by comparing the RSP+ \& MM treatment arm with the RSP+ treatment arm. This answers RQ1a: If MM has an impact, then researchers will answer RQ1b by comparing the RSP+ treatment arm with the control arm. If there's no impact, then RQ1b will be answered by comparing the pooled RSP+ and RSP+ \& MM treatment arms with the control arm. This study is funded through the Personal Responsibility Education Program Innovative Strategies (PREIS), which is administered by the Family and Youth Services Bureau, part of Health and Human Services, Trinity Church, Miami Gardens, is responsible for site and participant recruitment as well as the implementation of the intervention. Participants are randomized at the classroom level. All control group participants will only receive a financial literacy program. AMTC \& Associates is the external evaluator, The Dibble Institute is the curricula developer.

The intervention combines the pregnancy prevention curriculum, Relationship Smarts Plus (RSP+) with lessons from the trauma coping skills curriculum, Mind Matters (MM). The mental health component was added to assess the importance of mental health as a risk factor for teen pregnancy. Researchers will estimate the effect of Mind Matters (MM) by comparing the RSP+ \& MM treatment arm with the RSP+ treatment arm. This answers RQ1a: If MM has an impact, then researchers will answer RQ1b by comparing the RSP+ treatment arm with the control arm. If there's no impact, then RQ1b will be answered by comparing the pooled RSP+ and RSP+ \& MM treatment arms with the control arm.

This study is funded through the Personal Responsibility Education Program Innovative Strategies (PREIS), which is administered by the Family and Youth Services Bureau, part of Health and Human Services,

Trinity Church, Miami Gardens, is responsible for site and participant recruitment as well as the implementation of the intervention. Participants are randomized at the classroom level. All control group participants will only receive a financial literacy program.

AMTC \& Associates is the external evaluator, The Dibble Institute is the curricula developer.

Status Flow

~Jul 2023 – ~Jan 2024 · 6 months · monthly snapshotRecruiting~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Oct 2025 · 13 months · monthly snapshotRecruiting~Oct 2025 – ~May 2026 · 7 months · monthly snapshotActive Not RecruitingMay 4, 2026 – present · 2 months · daily API

Change History

6 versions recorded
  1. May 4, 2026 — Present [daily]

    Active Not Recruiting

    Phase: NANone

  2. Oct 2025 — May 2026 [monthly]

    Active Not Recruiting NA

    Status: RecruitingActive Not Recruiting

  3. Sep 2024 — Oct 2025 [monthly]

    Recruiting NA

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting NA

  5. Jan 2024 — Jul 2024 [monthly]

    Recruiting NA

Show 1 earlier version
  1. Jul 2023 — Jan 2024 [monthly]

    Recruiting NA

    First recorded

Eligibility Summary

The goal of this randomized control trial (RCT) is to assess an innovative adolescent pregnancy prevention program among youth that are at the highest risk of adolescent pregnancy, to prevent pregnancy and Sexually Transmitted Infections (STIs), including HIV/AIDS in the greater Miami area in Florida. The primary research question it aims to answer is: (RQ1a): What is the effect of adding 4.5-hours from the Mind Matters trauma-coping skills curriculum to the Relationship Smarts Plus curriculum, on rates of unprotected sex among 13-19-year-old youth compared to those receiving only the Relationship Smarts Plus curriculum? (RQ1b): What is the effect of the Relationship Smarts Plus curriculum on rates of unprotected sex among 13-19-year-old youth compared to the control group receiving only financial literacy? Participants will complete program lessons and complete surveys for data collection. The RCT will assess behavioral health outcomes and other psychological outcomes at four-time points (baseline, post-program, 3 months, and 12 months)

Contact Information

Sponsor contact:
  • AMTC & Associates
  • Department of Health and Human Services
  • Trinity Church Inc.
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations