"Healthy Futures" Program for Preventing Teen Pregnancy in Latinos

Overseen By Romina L Barral

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Mercy Hospital Kansas City

Disqualifiers: Developmental delay, Behavioral issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to develop and test the "Healthy Futures" program, which is designed to prevent unintended teen pregnancies among Latino teens. Workshops will deliver the program to both teens and their parents or guardians, with sessions available in English or Spanish. Participants will provide feedback on program delivery and complete surveys to assess its acceptability and impact on risky behaviors. Teens aged 14-18 who speak English or Spanish and have a parent or legal guardian willing to participate may be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for community health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe for preventing teen pregnancy in Latinos?

Research has shown that the "Healthy Futures" program aims to prevent teen pregnancy among Latino youth by using a community-based approach to reduce risky sexual behaviors. Previous tests of the program have demonstrated positive effects on teens, such as delaying the onset of sexual activity.

For safety, the program includes educational workshops rather than medication or medical procedures, eliminating direct health risks associated with drugs or surgeries. It focuses on providing information and skills to teens and their families in a safe setting.

As this trial is in its early stages, specific safety data is not yet available. However, the program's nature and past evaluations suggest it is well-received and poses minimal risk to participants. Participants will complete surveys during the study to ensure the program remains acceptable and does not cause any unexpected negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the "Healthy Futures" program because it takes a fresh approach to preventing teen pregnancy among Latinos. Unlike traditional methods that often focus solely on sex education, this program involves both teens and their parents or guardians in a series of interactive workshops. These sessions can be tailored to the participants' preferences, offering flexibility in delivery (virtual, in-person, or hybrid) and language (Spanish or English). This collaborative and adaptable format aims to create a supportive environment for open communication and education, which could lead to more effective prevention outcomes.

What evidence suggests that the "Healthy Futures" program is effective for preventing teen pregnancy in Latinos?

Studies have shown that the "Healthy Futures" program effectively reduces sexual behaviors among middle school students, helping to prevent teen pregnancies. Research indicates that this program employs a community-wide, evidence-based approach specifically designed for this purpose. Evaluations of the program have demonstrated an increase in the number of adolescents who delay starting sexual activities. Adapted from a proven teen pregnancy prevention curriculum, the program has shown positive outcomes in changing behaviors. These findings suggest that the "Healthy Futures" program could effectively prevent unintended teen pregnancies among Latino youth. ^{1 2 3 5 6}

Who Is on the Research Team?

Romina L Barral, M.D.

Principal Investigator

Children's Mercy Hospital Kansas City

Are You a Good Fit for This Trial?

This trial is for Latino teens aged 14-18 who speak English or Spanish. It's focused on preventing unintended pregnancies in rural areas. Teens with developmental delays, significant behavioral health issues, those who are incarcerated, or in foster care cannot participate.

Inclusion Criteria

You identify as Latino.

Exclusion Criteria

Developmental delayed

Have significant behavioral health issues which may interfere with study participation

I am a minor currently in detention.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Co-development

Co-development sessions with community partners to create a teen pregnancy prevention intervention

8 sessions

Hybrid sessions (in-person and virtual)

Pilot Study

Pilot testing of the co-developed intervention in a workshop format

8 sessions for teens, 2 sessions for parents/guardians

Sessions conducted in-person, virtual, or hybrid

Follow-up

Participants are monitored for acceptability and risk behaviors post-intervention

12 months

Surveys at 3, 6, and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Healthy futures

Trial Overview

The 'Healthy futures' ('Futuros Saludables') program is being tested to see if it can help prevent teen pregnancy among Latinos. The study will develop and try out this new intervention using exploratory research methods.

How Is the Trial Designed?

Group I: One arm pilot trial Experimental Treatment 1 Intervention

The developed intervention will be delivered in a workshop format by facilitators, over 8 sessions for teens and parent/guardian(s). Feedback will be elicited on delivery mode (virtual, in-person, or hybrid) during the co-development sessions. If in-person/hybrid is suggested, feedback will be elicited about preferred location (e.g., a local community center, sports club, etc.). Sessions will be hosted in either Spanish or English depending on participants' preference, using video conference tools. Teens and parent/guardian(s) will complete a 20-minute survey pre-intervention, immediately after the 8 session intervention, three-month post-intervention, six-month post-intervention, and twelve-month post-intervention. Surveys will assess acceptability and risk behaviors. As in the published Cuidate trials, previously used measures will be used to document validity and comparability.

Who Is Running the Clinical Trial?

Children's Mercy Hospital Kansas City

Lead Sponsor

Trials

261

Recruited

941,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A systematic review of 68 articles identified 15 interventions aimed at improving sexual health behaviors among Latino adolescents, focusing primarily on STI and HIV/AIDS prevention through individual and interpersonal behavior change strategies.

There is a significant gap in research targeting Latino adolescent males, highlighting the need for more culturally-sensitive and age-specific interventions to effectively address sexual health issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sexual health behavior interventions for U.S. Latino adolescents: a systematic review of the literature. Cardoza, VJ., Documét, PI., Fryer, CS., et al.[2021]

The Nurse-Family Partnership pilot study, which involved 225 Hispanic adolescent mothers, showed that enhanced home visitation by trained public health nurses led to lower rates of premature births compared to the general population of adolescent mothers in California.

Both the intervention and control groups benefited from home visits, indicating that public health nurse support can improve pregnancy outcomes for adolescent mothers and their infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison pilot study of public health field nursing home visitation program interventions for pregnant Hispanic adolescents. Nguyen, JD., Carson, ML., Parris, KM., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5049460/

Healthy Futures Program and Adolescent Sexual ...

We evaluated the impact of the 3-year Healthy Futures program on reducing sexual behaviors among middle school students.

2.

withpower.com

withpower.com/trial/phase-pregnancy-in-adolescence-8-2022-62429

"Healthy Futures" Program for Preventing Teen Pregnancy ...

The 'Healthy Futures' program is unique because it is a community-wide, evidence-based approach specifically designed to reduce sexual behaviors among ...

3.

opa.hhs.gov

opa.hhs.gov/research-evaluation/teen-pregnancy-prevention-program-evaluations/summary-programs-effective-changing-behavior

Summary of Evaluated Programs Effective at Changing Behavior

The program was adapted from an existing evidence-based teen pregnancy prevention program ... Healthy Futures. Healthy Futures is a school-based, sex education ...

4.

healthy-futures.org

healthy-futures.org/2023-teen-pregnancy-prevention-tpp-tier-1-toolkit/

2023 Teen Pregnancy Prevention (TPP) Tier 1 Toolkit

Healthy Futures Nu-CULTURE was found effective at increasing the percentage of adolescents that delay the initiation of sexual. The study ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06105905

NCT06105905 | Latino Teen Pregnancy Prevention K23

Pregnancy in AdolescenceRural HealthHispanic or Latino. Intervention / Treatment. Behavioral : Healthy futures ("Futuros Saludables"). Other Study ID Numbers.

6.

cms.childtrends.org

cms.childtrends.org/wp-content/uploads/2014/02/2013-03PreventingLatinosPregnancies.pdf

Preventing Teen Pregnancy among Latinos:

Lessons from adolescent pregnancy prevention program evaluations. Few evaluations of pregnancy prevention programs serving Latinos examine behavioral outcomes.