"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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The study will utilize an exploratory study design, applying formative research methods to inform the development and pilot testing of an unintended teen pregnancy prevention intervention.

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 data supports the effectiveness of the treatment Healthy Futures for preventing teen pregnancy in Latinos?

The AIM for Teen Moms program showed that providing social support can improve contraceptive use among young mothers, which helps prevent rapid repeat pregnancies. Additionally, the Generations program demonstrated that a comprehensive approach, including medical care and social services, improved contraceptive and condom use among teen mothers, suggesting similar strategies could be effective in the Healthy Futures program. ^{1 2 3 4 5}

How is the 'Healthy Futures' treatment different from other teen pregnancy prevention treatments for Latino adolescents?

The 'Healthy Futures' program is unique because it is a community-wide, evidence-based approach specifically designed to reduce sexual behaviors among Latino adolescents, focusing on culturally relevant strategies and family-based interventions. Unlike other treatments, it emphasizes a comprehensive, long-term engagement with middle school students to address the unique reproductive health needs of Latino youth. ^{6 7 8 9 10}

Research Team

Romina L Barral, M.D.

Principal Investigator

Children's Mercy Hospital Kansas City

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 2 sessions for 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. Parent/guardian(s) will complete a 5-minute survey pre-intervention and immediately post-intervention. Teens will complete a 15-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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A comparison pilot study of public health field nursing home visitation program interventions for pregnant Hispanic adolescents. [2021]

2. England pubmed.ncbi.nlm.nih.gov

A comparative assessment of early adult life status of graduates of the North Carolina adolescent parenting program. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

AIM for Teen Moms: Social Support's Role in Contraception Use Among Young Mothers. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Birth weight outcomes in a teenage pregnancy case management project. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Improved Contraceptive Use Among Teen Mothers in a Patient-Centered Medical Home. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sexual health behavior interventions for U.S. Latino adolescents: a systematic review of the literature. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Healthy Futures Program and Adolescent Sexual Behaviors in 3 Massachusetts Cities: A Randomized Controlled Trial. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Latino Adolescent Reproductive and Sexual Health Behaviors and Outcomes: Research Informed Guidance for Agency-based Practitioners. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Why We Need Evidence-Based, Community-Wide Approaches for Prevention of Teen Pregnancy. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Brief Home Parenting Intervention for Reducing Early Sexual Risks Among Latino Adolescents: Salud y Éxito. [2023]