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

Primary Purpose

Teen Pregnancy, Contraception Behavior, Sexually Transmitted Diseases

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relationship Smarts Plus & Mind Matters
Relationship Smarts Plus alone
Preparing Adolescents for Young Adulthood (PAYA).
Sponsored by
Trinity Church Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Teen Pregnancy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 or 10th 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. 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. 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.

Sites / Locations

  • Trinity Church IncRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Relationship Smarts Plus & Mind Matters

Relationship Smarts Plus

Control Group

Arm 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).

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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
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
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
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
May 12, 2023
Last Updated
June 1, 2023
Sponsor
Trinity Church Inc.
Collaborators
AMTC & Associates, Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT05889689
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trinity Church Inc.
Collaborators
AMTC & Associates, Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teen Pregnancy, Contraception Behavior, Sexually Transmitted Diseases, Reproductive Health, Sexual Risk Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Relationship Smarts Plus & Mind Matters
Arm Type
Experimental
Arm 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).
Arm Title
Relationship Smarts Plus
Arm Type
Experimental
Arm Description
Relationship Smarts Plus (RSP+) is an adolescent pregnancy prevention curriculum.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Financial literacy curriculum, Preparing Adolescents for Young Adulthood (PAYA)
Intervention Type
Behavioral
Intervention Name(s)
Relationship Smarts Plus & Mind Matters
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Relationship Smarts Plus alone
Intervention Description
14-hour-long curriculum that addresses pregnancy prevention within the context of teaching relationship skills for young teens.
Intervention Type
Behavioral
Intervention Name(s)
Preparing Adolescents for Young Adulthood (PAYA).
Intervention Description
A financial literacy curriculum
Primary Outcome Measure Information:
Title
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.
Description
The proportion of youth who, in comparison to the control group, report lower rates of unprotected sex
Time Frame
At 12 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report lower rates of unprotected sex
Time Frame
At 3 months after baseline data collection
Secondary Outcome Measure Information:
Title
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
Description
The proportion of youth who, in comparison to the control group, report lower rates of sexual intercourse
Time Frame
At 12 months after baseline data collection
Title
Sexual intercourse as measured by a binary indicator asking participants if they ever engaged in sexual intercourse
Description
The proportion of youth who, in comparison to the control group, report lower rates of sexual intercourse
Time Frame
At 3 months after baseline data collection
Title
Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex
Description
The proportion of youth who, in comparison to the control group, report lower rates of oral sex
Time Frame
At 12 months after baseline data collection
Title
Oral sex as measured by a single binary indicator asking participants if they ever engaged in oral sex
Description
The proportion of youth who, in comparison to the control group, report lower rates of oral sex
Time Frame
At 3 months after baseline data collection
Title
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
Description
The proportion of youth who, in comparison to the control group, report lower rates of sexual initiation
Time Frame
At 3 months and at 12 months after baseline data collection
Title
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
Description
The proportion of youth who, in comparison to the control group, report lower rates of sexual initiation
Time Frame
At 12 months after baseline data collection
Title
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.
Description
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.
Time Frame
At 12 months after baseline data collection
Title
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.
Description
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.
Time Frame
At 3 months after baseline data collection
Title
Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives
Description
The proportion of youth who, in comparison to the control group, report intent to consistently use condoms.
Time Frame
At 3 months and at 12 months after baseline data collection
Title
Intent to use condoms as measured by a binary indicator that asks participants if they will use condoms and other contraceptives
Description
The proportion of youth who, in comparison to the control group, report intent to consistently use condoms.
Time Frame
At 12 months after baseline data collection
Title
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
Description
The proportion of youth who, in comparison to the control group, report higher knowledge of HIV/STIs.
Time Frame
At 12 months after baseline data collection
Title
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
Description
The proportion of youth who, in comparison to the control group, report higher knowledge of HIV/STIs.
Time Frame
At 3 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report having future-oriented goals
Time Frame
At 12 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report having future-oriented goals
Time Frame
At 3 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report more health life skills
Time Frame
At 12 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report more health life skills
Time Frame
At 3 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report higher awareness of healthy relationships
Time Frame
At 12 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report higher awareness of healthy relationships
Time Frame
At 3 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report more communication skills
Time Frame
At 12 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report more communication skills
Time Frame
At 3 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report more communication skills
Time Frame
At 12 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report more communication skills
Time Frame
At 3 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report more conflict resolution skills
Time Frame
At 3 months and at 12 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report more conflict resolution skills
Time Frame
At 12 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report higher resiliency
Time Frame
At 12 months after baseline data collection
Title
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.
Description
The proportion of youth who, in comparison to the control group, report higher resiliency
Time Frame
At 3 months after baseline data collection

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 or 10th 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. 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Immaculate Apchemengich
Phone
4144398090
Email
immaculate.apchemengich207@amtcassociates.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cindy Walker, PhD
Phone
4142182442
Email
cindy@researchanalyticsconsulting.com
Facility Information:
Facility Name
Trinity Church Inc
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Williams
First Name & Middle Initial & Last Name & Degree
Cindy Walker, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At this time, there is no plan to share Individual Participant Data with other researchers

Learn more about this trial

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

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