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.
1 other identifier
interventional
945
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2023
CompletedFirst Posted
Study publicly available on registry
June 5, 2023
CompletedStudy Start
First participant enrolled
September 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedApril 30, 2026
May 1, 2025
2.6 years
May 12, 2023
April 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Unprotected sex as measured by 4 items from the survey. The 4 items will be combined to create a binary variable as an indicator of either protected sex or unprotected sex.
The proportion of youth who, in comparison to the control group, report lower rates of unprotected sex
At 12 months after baseline data collection
Secondary Outcomes (25)
Unprotected sex as measured by 4 items from the survey. The 4 items will be combined to create a binary variable as an indicator of either protected sex or unprotected sex.
At 3 months after baseline data collection.
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
At 12 months after baseline data collection
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
At 3 months after baseline data collection
Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex
At 12 months after baseline data collection
Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex
At 3 months after baseline data collection
- +20 more secondary outcomes
Study Arms (3)
Relationship Smarts Plus & Mind Matters
EXPERIMENTALRelationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum that will be combined with lessons from a trauma-coping skills curriculum, Mind Matters (MM).
Relationship Smarts Plus
EXPERIMENTALRelationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum.
Control Group
ACTIVE COMPARATORFinancial literacy curriculum, Preparing Adolescents for Young Adulthood (PAYA)
Interventions
18.5 hours long intervention that combines the Relationship Smarts Plus teen pregnancy prevention curriculum with lessons from the Mind Matters trauma-coping skills curriculum
14-hour-long curriculum that addresses pregnancy prevention within the context of teaching relationship skills for young teens.
A financial literacy curriculum
Eligibility Criteria
You may qualify if:
- For schools to be included in the study:
- They have to be located within the greater Miami area.
- For individuals:
- Students enrolled in either 9th,10th, 11th and 12th grade
- Students who do not have severe cognitive, mental health, or behavioral impairment.
- Students with Individualized Education Plans who are part of the mainstream classrooms.
- Youth aged 13-19 residing in the greater Miami-Dade Communities
You may not qualify if:
- Students who do not consent to be in the study
- Students who are part of the pilot study
- Students who have been randomized in a previous cohort of the study
- Students with an Individualized Education Plan (IEP) who are in restricted placement will not be able to participate in the program as they will not be part of the mainstream classrooms where the program is implemented.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Trinity Church Inc.lead
- AMTC & Associatescollaborator
- Department of Health and Human Servicescollaborator
Study Sites (1)
Trinity Church Inc
Miami Gardens, Florida, 33169, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2023
First Posted
June 5, 2023
Study Start
September 23, 2023
Primary Completion
April 30, 2026
Study Completion
April 30, 2026
Last Updated
April 30, 2026
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
At this time, there is no plan to share Individual Participant Data with other researchers