An interventional study of Relationship Smarts Plus & Mind Matters and Relationship Smarts Plus alone in Teen Pregnancy, Contraception Behavior and Sexually Transmitted Diseases, sponsored by Trinity Church Inc.. Active, not recruiting at 1 site in United States. Open to participants aged 13 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Trinity Church Inc. · Not applicable, Interventional, and Prevention
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)
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.
132 studies on the registry are indexed under Contraception Behavior; 20 are open to participants now.
This study's planned enrollment of 945 is above the median of 382 across 106 interventional studies indexed under Contraception Behavior.
Browse Contraception Behavior studies →This is the only study on the registry with Trinity Church Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For schools to be included in the study:
They have to be located within the greater Miami area.
For individuals:
Exclusion Criteria:
Relationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum that will be combined with lessons from a trauma-coping skills curriculum, Mind Matters (MM).
Behavioral: Relationship Smarts Plus & Mind Matters
Relationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum.
Behavioral: Relationship Smarts Plus alone
Financial literacy curriculum, Preparing Adolescents for Young Adulthood (PAYA)
Behavioral: Preparing Adolescents for Young Adulthood (PAYA).
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
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
Time frame: At 12 months after baseline data collection
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.
Time frame: At 3 months after baseline data collection.
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
The proportion of youth who, in comparison to the control group, report lower rates of sexual intercourse
Time frame: At 12 months after baseline data collection
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
The proportion of youth who, in comparison to the control group, report lower rates of sexual intercourse
Time frame: 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
The proportion of youth who, in comparison to the control group, report lower rates of oral sex
Time frame: 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
The proportion of youth who, in comparison to the control group, report lower rates of oral sex
Time frame: At 3 months after baseline data collection
Sexual Initiation as measured by a 7- item 5 response ordinal scale categorical indicator of when individuals intent to start engaging in different sexual activities
The proportion of youth who, in comparison to the control group, report lower rates of sexual initiation
Time frame: At 3 months and at 12 months after baseline data collection
Sexual Initiation as measured by a 7- item 5 response ordinal scale categorical indicator of when individuals intent to start engaging in different sexual activities
The proportion of youth who, in comparison to the control group, report lower rates of sexual initiation
Time frame: At 12 months after baseline data collection
Skills to negotiate abstinence & resist pressure to have sex measured by a 10-item scale on a 5-point scale showing how confident they are in answering each of the 10 items. A score will be calculated by averaging their responses.
The proportion of youth who, in comparison to the control group, report they have the skills to negotiate abstinence and resist pressure to have sex.
Time frame: At 12 months after baseline data collection
Skills to negotiate abstinence & resist pressure to have sex measured by a 10-item scale on a 5-point scale showing how confident they are in answering each of the 10 items. A score will be calculated by averaging their responses.
The proportion of youth who, in comparison to the control group, report they have the skills to negotiate abstinence and resist pressure to have sex.
Time frame: At 3 months after baseline data collection
Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives
The proportion of youth who, in comparison to the control group, report intent to consistently use condoms.
Time frame: At 3 months and at 12 months after baseline data collection
Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives
The proportion of youth who, in comparison to the control group, report intent to consistently use condoms.
Time frame: At 12 months after baseline data collection
Knowledge of HIV/STIs as measured by 8-item True/False/Unsure responses to survey items. Items will be scored as 1 if correct & 0 if incorrect. Composite scores of correct items will be calculated. Scores range from 0 to 8
The proportion of youth who, in comparison to the control group, report higher knowledge of HIV/STIs.
Time frame: At 12 months after baseline data collection
Knowledge of HIV/STIs as measured by 8-item True/False/Unsure responses to survey items. Items will be scored as 1 if correct & 0 if incorrect. Composite scores of correct items will be calculated. Scores range from 0 to 8
The proportion of youth who, in comparison to the control group, report higher knowledge of HIV/STIs.
Time frame: At 3 months after baseline data collection
Future-oriented goals as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report having future-oriented goals
Time frame: At 12 months after baseline data collection
Future-oriented goals as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report having future-oriented goals
Time frame: At 3 months after baseline data collection
Healthy life skills measured by a 12-item 6-point response scale, respondents will show how much they agree or disagree with each of the 12 items. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more health life skills
Time frame: At 12 months after baseline data collection
Healthy life skills measured by a 12-item 6-point response scale, respondents will show how much they agree or disagree with each of the 12 items. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more health life skills
Time frame: At 3 months after baseline data collection
Awareness of healthy relationships as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report higher awareness of healthy relationships
Time frame: At 12 months after baseline data collection
Awareness of healthy relationships as measured by a 10-item 6-point response scale, respondents will show how much they agree or disagree with each of the 10 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report higher awareness of healthy relationships
Time frame: At 3 months after baseline data collection
General communication skills as measured by a 7-item scale on a 5-point scale, respondents will show how much they agree or disagree with each of the 7 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more communication skills
Time frame: At 12 months after baseline data collection
General communication skills as measured by a 7-item scale on a 5-point scale, respondents will show how confident they are with each of the 7 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more communication skills
Time frame: At 3 months after baseline data collection
Conflict resolution skills as measured using 8 items on a 5-point scale, respondents will show how confident they are in answering each of the 8 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more conflict resolution skills
Time frame: At 3 months and at 12 months after baseline data collection
Conflict resolution skills as measured using 8 items on a five-point response scale, respondents will show how confident they are in answering each of the 8 statements. A score will be calculated for each of the respondents by averaging their responses.
The proportion of youth who, in comparison to the control group, report more conflict resolution skills
Time frame: At 12 months after baseline data collection
Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC). A 5 point rating of how participants have felt over the past month. Scores range from 0-4. An average score will be calculated.
The proportion of youth who, in comparison to the control group, report higher resiliency
Time frame: At 12 months after baseline data collection
Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC). A 5 point rating of how participants have felt over the past month. Scores range from 0-4. An average score will be calculated.
The proportion of youth who, in comparison to the control group, report higher resiliency
Time frame: At 3 months after baseline data collection
Plan to share: No — At this time, there is no plan to share Individual Participant Data with other researchers
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.