Active, Not Recruiting

NCT Number: NCT05889689

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

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Teen Pregnancy Behavior Communicable Diseases Contraception Behavior Disease Attributes Genital Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Reproductive Behavior Reproductive Health Sexual Risk Behavior Sexually Transmitted Diseases Urogenital Diseases

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trinity Church Inc

Miami Gardens, Florida, 33169, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Relationship Smarts Plus & Mind Matters

Behavioral

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

Relationship Smarts Plus alone

Behavioral

14-hour-long curriculum that addresses pregnancy prevention within the context of teaching relationship skills for young teens.

Preparing Adolescents for Young Adulthood (PAYA).

Behavioral

A financial literacy curriculum

Primary outcomes

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.

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report lower rates of unprotected sex

Secondary outcomes

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.

Time frame: At 3 months after baseline data collection.

The proportion of youth who, in comparison to the control group, report lower rates of unprotected sex.
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report lower rates of sexual intercourse
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse

Time frame: At 3 months after baseline data collection

The proportion of youth who, in comparison to the control group, report lower rates of sexual intercourse
Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report lower rates of oral sex
Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex

Time frame: At 3 months after baseline data collection

The proportion of youth who, in comparison to the control group, report lower rates of oral sex
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

Time frame: At 3 months and at 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report lower rates of sexual initiation
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

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report lower rates of sexual initiation
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.

Time frame: At 12 months after baseline data collection

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.
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.

Time frame: At 3 months after baseline data collection

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.
Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives

Time frame: At 3 months and at 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report intent to consistently use condoms.
Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report intent to consistently use condoms.
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

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report higher knowledge of HIV/STIs.
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

Time frame: At 3 months after baseline data collection

The proportion of youth who, in comparison to the control group, report higher knowledge of HIV/STIs.
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.

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report having future-oriented goals
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.

Time frame: At 3 months after baseline data collection

The proportion of youth who, in comparison to the control group, report having future-oriented goals
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.

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report more health life skills
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.

Time frame: At 3 months after baseline data collection

The proportion of youth who, in comparison to the control group, report more health life skills
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.

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report higher awareness of healthy relationships
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.

Time frame: At 3 months after baseline data collection

The proportion of youth who, in comparison to the control group, report higher awareness of healthy relationships
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.

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report more communication skills
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.

Time frame: At 3 months after baseline data collection

The proportion of youth who, in comparison to the control group, report more communication skills
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.

Time frame: At 3 months and at 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report more conflict resolution skills
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.

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report more conflict resolution skills
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.

Time frame: At 12 months after baseline data collection

The proportion of youth who, in comparison to the control group, report higher resiliency
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.

Time frame: At 3 months after baseline data collection

The proportion of youth who, in comparison to the control group, report higher resiliency

Sponsors and collaborators

Lead sponsor

Trinity Church Inc.

Other

Collaborators

AMTC & Associates
Department of Health and Human Services

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Jun 5, 2023
Registry last updated: Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Trinity Church Inc

About this study

Who can participate

Treatment and study plan

Relationship Smarts Plus & Mind Matters

Relationship Smarts Plus alone

Preparing Adolescents for Young Adulthood (PAYA).

Primary outcomes

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.

Secondary outcomes

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.

Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse

Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse

Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex

Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex

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

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

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.

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.

Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives

Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Sponsors and collaborators

Lead sponsor

Collaborators

Registry information

Official study title

Important dates

Related clinical trials

An Evaluation of Pono Choices: A Culturally Responsive Teen Pregnancy and STI Prevention Program

Evaluation of My Future Self, an New Teen Pregnancy Prevention Group Intervention for Youth in Non-traditional Settings

Knowledge and Habits of Pregnant Teens

Evaluation of the Impact of the IN•Clued Curriculum: An LGBTQ Sex ed Program