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.
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)
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02579135 -
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
|
N/A | |
| Enrolling by invitation |
NCT06127277 -
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
|
N/A | |
| Completed |
NCT02516930 -
A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China
|
N/A | |
| Completed |
NCT03063385 -
Puerto Rico Cuidalos Parent-adolescent Program
|
N/A | |
| Completed |
NCT02009046 -
Randomized Evaluation of a Multi-Component, Rights-Based Sexuality Education Initiative for High School Students
|
N/A | |
| Completed |
NCT01411878 -
Louisville Teen Pregnancy Prevention Project
|
N/A | |
| Completed |
NCT01303575 -
Internet-Based Sexual Health Education for Middle School Native American Youth
|
N/A | |
| Completed |
NCT00167505 -
All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students
|
N/A | |
| Completed |
NCT00183456 -
A Peer-Oriented HIV Prevention Outreach Program for Individuals at High Risk for HIV and Other STIs
|
Phase 2 | |
| Completed |
NCT00336180 -
Adolescent Drug and HIV Prevention in South Africa
|
Phase 2/Phase 3 | |
| Completed |
NCT00161382 -
Development and Evaluation of an HIV, STD, and Pregnancy Prevention Program for Middle School Students
|
N/A | |
| Completed |
NCT01084395 -
Reducing HIV Risk Among Mexican Youth
|
N/A | |
| Completed |
NCT00710060 -
Effectiveness of a Community-level HIV/STD Prevention Intervention in Promoting Safer Sexual Behaviors in High-risk Populations
|
Phase 3 | |
| Completed |
NCT00640653 -
Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents
|
N/A | |
| Completed |
NCT00289939 -
Reducing HIV & Domestic Violence Risk in Women Offenders
|
Phase 3 | |
| Completed |
NCT00137943 -
Parents Matter!: Interventions to Promote Effective Parent-Child Communication
|
Phase 1 | |
| Completed |
NCT03408743 -
Engineering an Online STI Prevention Program: CSE2
|
N/A | |
| Completed |
NCT06104813 -
Evaluation of Deaf Men's Knowledge About Sexual Health
|
||
| Not yet recruiting |
NCT05910580 -
Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
|
N/A | |
| Completed |
NCT03352219 -
Reality Check: An HIV Risk Reduction Serial Drama
|
N/A |