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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Sexually Transmitted Diseases; Contraception Behavior; Sexual Risk Behavior; Teen Pregnancy; Reproductive Health
• Intervention / Treatment: Behavioral: Relationship Smarts Plus & Mind Matters; Behavioral: Relationship Smarts Plus alone; Behavioral: Preparing Adolescents for Young Adulthood (PAYA).

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.

• Study Type: Interventional
• Enrollment (Estimated): 2250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Immaculate Apchemengich; Phone Number: 4144398090; Email: immaculate.apchemengich207@amtcassociates.com
• Study Contact Backup: Name: Cindy Walker, PhD; Phone Number: 4142182442; Email: cindy@researchanalyticsconsulting.com

Study Locations

• United States
  • Florida
    • Miami Gardens, Florida, United States, 33169
      • Recruiting
      • Trinity Church Inc
      • Contact: Christian Williams
      • Principal Investigator: Cindy Walker, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Relationship Smarts Plus & Mind Matters; 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; 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
Experimental: Relationship Smarts Plus; Relationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum.	Behavioral: Relationship Smarts Plus alone; 14-hour-long curriculum that addresses pregnancy prevention within the context of teaching relationship skills for young teens.
Active Comparator: Control Group; Financial literacy curriculum, Preparing Adolescents for Young Adulthood (PAYA)	Behavioral: Preparing Adolescents for Young Adulthood (PAYA).; A financial literacy curriculum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Trinity Church Inc.
• Collaborators: Department of Health and Human Services; AMTC & Associates

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2023
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 30, 2025

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases
• Other Study ID Numbers: 90AP2700-01-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At this time, there is no plan to share Individual Participant Data with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No