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

Trinity Church Inc.

Status: Active, not recruiting

Conditions: Sexually Transmitted Diseases; Sexual Risk Behavior; Contraception Behavior; Reproductive Health; Teen Pregnancy

Treatments: Behavioral: Preparing Adolescents for Young Adulthood (PAYA).; Behavioral: Relationship Smarts Plus & Mind Matters; Behavioral: Relationship Smarts Plus alone

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05889689

90AP2700-01-00

Details and patient eligibility

About

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 of Mind Matters trauma-coping skills curriculum to the Relationship Smarts Plus curriculum, on rates of unprotected sex among 9th and 10th graders compared to the students receiving only the 14-hour-long Relationship Smarts Plus curriculum? (RQ1b): What is the effect of the 14-hour-long Relationship Smarts Plus curriculum on rates of unprotected sex among 9th and 10th graders 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)

Full description

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.

Enrollment: 2,250 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For schools to be included in the study:

They have to be located within the greater Miami area.

For individuals:

1. Students enrolled in either 9th,10th, 11th and 12th grade
2. Students who do not have severe cognitive, mental health, or behavioral impairment.
3. Students with Individualized Education Plans who are part of the mainstream classrooms.

Exclusion criteria

1. Students who do not consent to be in the study
2. Students who are part of the pilot study
3. Students who have been randomized in a previous cohort of the study
4. 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.
5. Students who have received such a program within the last year will be eligible to participate in the program but will be excluded from statistical analysis to ensure the results are not biased from participation in a similar curriculum.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,250 participants in 3 patient groups

Relationship Smarts Plus & Mind Matters

Experimental group

Description:

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).

Treatment:

Behavioral: Relationship Smarts Plus & Mind Matters

Relationship Smarts Plus

Experimental group

Description:

Relationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum.

Treatment:

Behavioral: Relationship Smarts Plus alone

Control Group

Active Comparator group

Description:

Financial literacy curriculum, Preparing Adolescents for Young Adulthood (PAYA)

Treatment:

Behavioral: Preparing Adolescents for Young Adulthood (PAYA).