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

Sexually Transmitted Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05889689
• Other study ID #: 90AP2700-01-00
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2023
• Est. completion date: March 30, 2025

Study information

• Verified date: December 2023
• Source: Trinity Church Inc.
• Contact: Immaculate Apchemengich
• Phone: 4144398090
• Email: immaculate.apchemengich207[@]amtcassociates.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2250
• Est. completion date: March 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Contraception Behavior
• Reproductive Health
• Sexual Risk Behavior
• Sexually Transmitted Diseases
• Teen Pregnancy

Intervention

Behavioral:
• Relationship Smarts Plus & Mind Matters
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
14-hour-long curriculum that addresses pregnancy prevention within the context of teaching relationship skills for young teens.
• Preparing Adolescents for Young Adulthood (PAYA).
A financial literacy curriculum

Locations

Country	Name	City	State
United States	Trinity Church Inc	Miami Gardens	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Trinity Church Inc.	AMTC & Associates, Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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 3 months after baseline data collection
Secondary	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	At 12 months after baseline data collection
Secondary	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	At 3 months after baseline data collection
Secondary	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	At 12 months after baseline data collection
Secondary	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	At 3 months after baseline data collection
Secondary	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	At 3 months and at 12 months after baseline data collection
Secondary	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	At 12 months after baseline data collection
Secondary	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.	At 12 months after baseline data collection
Secondary	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.	At 3 months after baseline data collection
Secondary	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.	At 3 months and at 12 months after baseline data collection
Secondary	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.	At 12 months after baseline data collection
Secondary	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.	At 12 months after baseline data collection
Secondary	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.	At 3 months after baseline data collection
Secondary	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	At 12 months after baseline data collection
Secondary	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	At 3 months after baseline data collection
Secondary	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	At 12 months after baseline data collection
Secondary	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	At 3 months after baseline data collection
Secondary	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	At 12 months after baseline data collection
Secondary	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	At 3 months after baseline data collection
Secondary	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	At 12 months after baseline data collection
Secondary	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	At 3 months after baseline data collection
Secondary	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.	The proportion of youth who, in comparison to the control group, report more communication skills	At 12 months after baseline data collection
Secondary	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.	The proportion of youth who, in comparison to the control group, report more communication skills	At 3 months after baseline data collection
Secondary	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	At 3 months and at 12 months after baseline data collection
Secondary	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	At 12 months after baseline data collection
Secondary	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	At 12 months after baseline data collection
Secondary	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	At 3 months after baseline data collection