Clinical trial NCT05889689: Evaluation of an Adolescent Pregnancy Prevention Program; Relationship Smarts+ With Lessons From Mind Matters
Official title: Relationship Smarts Plus and Mind Matters: A Randomized Control Trial of a High School Intervention to Reduce Sexual Risk Behaviors.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Teen Pregnancy
Contraception Behavior
Sexually Transmitted Diseases
Reproductive Health
Sexual Risk Behavior
Lead sponsor: Trinity Church Inc.
Sponsor class: OTHER
Collaborators: name: AMTC & Associates
name: Department of Health and Human Services
First posted: 2023-06-05
Enrollment: 2250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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)

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: At 12 months after baseline data collection
measure: 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.
timeFrame: At 3 months after baseline data collection
Secondary outcomes:
measure: Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
timeFrame: At 12 months after baseline data collection
measure: Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
timeFrame: At 3 months after baseline data collection
measure: Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex
timeFrame: At 12 months after baseline data collection
measure: Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex
timeFrame: At 3 months after baseline data collection
measure: 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
timeFrame: At 3 months and at 12 months after baseline data collection
measure: 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
timeFrame: At 12 months after baseline data collection
measure: 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.
timeFrame: At 12 months after baseline data collection
measure: 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.
timeFrame: At 3 months after baseline data collection
measure: Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives
timeFrame: At 3 months and at 12 months after baseline data collection
measure: Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives
timeFrame: At 12 months after baseline data collection
measure: 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
timeFrame: At 12 months after baseline data collection
measure: 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
timeFrame: At 3 months after baseline data collection
measure: 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.
timeFrame: At 12 months after baseline data collection
measure: 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.
timeFrame: At 3 months after baseline data collection
measure: 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.
timeFrame: At 12 months after baseline data collection
measure: 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.
timeFrame: At 3 months after baseline data collection
measure: 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.
timeFrame: At 12 months after baseline data collection
measure: 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.
timeFrame: At 3 months after baseline data collection
measure: 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.
timeFrame: At 12 months after baseline data collection
measure: 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.
timeFrame: At 3 months after baseline data collection
measure: Parent/guardian communication about sex measured by a 6-item scale on a 5-point scale, respondents will show how confident they are in answering each of the 6 items. A score will be calculated for each of the respondents by averaging their responses.
timeFrame: At 12 months after baseline data collection
measure: Parent/guardian communication about sex measured by a 6-item scale on a 5-point scale, respondents will show how confident they are in answering each of the 6 items. A score will be calculated for each of the respondents by averaging their responses.
timeFrame: At 3 months after baseline data collection
measure: 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.
timeFrame: At 3 months and at 12 months after baseline data collection
measure: 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.
timeFrame: At 12 months after baseline data collection
measure: 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.
timeFrame: At 12 months after baseline data collection
measure: 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.
timeFrame: At 3 months after baseline data collection
Other outcomes:
Locations:
city: Miami Gardens
country: United States
facility: Trinity Church Inc
state: Florida
Study officials:
References: