Stepping Stones for Teen Pregnancy Prevention

(StSt Trial)

Overseen By Kelly Burgess, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Policy & Research Group

Disqualifiers: Pregnancy, Incarceration

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 6-8 weeks

650 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Stepping Stones (StSt) program to determine its impact on the sexual health and relationship behaviors of young people. Researchers aim to assess whether the program encourages more STI testing, reduces unprotected sex, and lowers emotional abuse among participants. The trial compares participants who receive the StSt program to those who do not receive any sexual health information. Young people who have been sexually active recently and are involved with legal or child welfare systems might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to important research that could shape future sexual health programs.

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 the Stepping Stones intervention is safe for youth?

Research has shown that the Stepping Stones (StSt) program has improved health and social behaviors in various studies. In one study, it did not significantly reduce new HIV cases but did lower several risk factors associated with HIV, such as rates of HSV-2 (a type of herpes virus) and incidents of intimate partner violence.

Another study combined Stepping Stones with a financial independence program, which reduced violence among young men and women. These studies did not specifically report negative effects or side effects, suggesting that the program is generally well-tolerated by participants, as it focuses on behavior change rather than medical treatments.

Overall, Stepping Stones is considered low-risk because it emphasizes behavior change. It aims to educate and empower individuals to make healthier choices and build better relationships. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stepping Stones program because it offers a fresh approach to teen pregnancy prevention. Unlike traditional methods that often focus solely on sexual education or abstinence, Stepping Stones takes a comprehensive approach by addressing the social and relationship dynamics that contribute to teen pregnancy. This method is unique because it empowers teens with communication skills and self-awareness, potentially leading to more informed and responsible decisions. By targeting the root causes of risky behaviors, Stepping Stones could provide a more holistic and effective solution compared to current options.

What evidence suggests that the Stepping Stones intervention is effective for improving sexual health and relationship behaviors in at-risk youth?

Research has shown that the Stepping Stones (StSt) program can improve sexual health habits. One study demonstrated that Stepping Stones reduced risky behaviors, such as having unprotected sex, which can prevent sexually transmitted infections (STIs) and HIV. The program also decreased violence and emotional abuse in relationships among young people. Participants reported positive changes in their attitudes and actions regarding sexual health. These findings suggest that Stepping Stones may positively impact the sexual health and safety of young people. In this trial, participants will be assigned to either the Stepping Stones program or a sham comparator group to evaluate the program's effectiveness. ^{2 3 4 6 7}

Who Is on the Research Team?

Sarah Walsh, Ph.D.

Principal Investigator

The Policy & Research Group

Are You a Good Fit for This Trial?

This trial is for sexually active youth aged 12-21 who are at risk or involved with juvenile justice/child welfare systems. It's not specified who can't join, but typically those unable to consent or follow the study protocol would be excluded.

Inclusion Criteria

At risk for or involved in the juvenile justice and/or child welfare systems

Comfortable reading, speaking, and writing in English

I have had vaginal or anal sex in the last 3 months.

Exclusion Criteria

Currently trying to start a pregnancy

Currently in jail or being detained in a facility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Stepping Stones intervention over four sessions during a 6-8 week period

6-8 weeks

4 visits (in-person for treatment group), virtual for control group

Follow-up

Participants are monitored for outcomes related to sexual health and relationship behaviors

11 months

3 visits (self-reported data collection at baseline, 5 months, and 11 months post-baseline)

What Are the Treatments Tested in This Trial?

Interventions

• Stepping Stones (StSt)

Trial Overview

The 'Stepping Stones' intervention is being tested against a control condition with no sexual health info. The study checks if StSt affects STI testing rates, condom use during sex, and emotional abuse perpetration after offering it over four sessions in person.

How Is the Trial Designed?

Group I: Stepping Stones Experimental Treatment 1 Intervention

Group II: Like Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

The Policy & Research Group

Lead Sponsor

Trials

12

Recruited

12,700+

Department of Health and Human Services Office of Population Affairs

Collaborator

Trials

4

Recruited

5,400+

Public Health - Seattle and King County

Collaborator

Trials

10

Recruited

8,600+

Reproductive Health National Training Center

Collaborator

Trials

4

Recruited

5,400+

Mathematica Policy Research, Inc.

Collaborator

Trials

68

Recruited

31,130,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Published Research Related to This Trial

Teenage pregnancy is increasingly recognized as a significant social issue in the United States, prompting the need for effective prevention strategies.

The proposed comprehensive prevention program focuses on cognitive-behavioral training techniques to equip adolescents with the skills needed to prevent unwanted pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing unwanted adolescent pregnancy: a cognitive-behavioral approach. Schinke, SP., Gilchrist, LD., Small, RW.[2017]

The Innovative Teen Pregnancy Prevention Programs (iTP3) project successfully developed new programs aimed at preventing teen pregnancy among at-risk populations by using both traditional and design-focused funding models.

Evaluation of the programs revealed that the design-focused model, which emphasized human-centered design, resulted in notable differences in program length and resource requirements compared to traditional funding methods, highlighting the importance of tailored approaches in program development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A program evaluation of the Innovative Teen Pregnancy Prevention Programs (iTP3) Project. Garcia, KM., Esquivel, CH., Garney, WR., et al.[2022]

The study found that a coordinated intervention for teen mothers, which included social work services and comprehensive health care, significantly reduced subsequent births, with only 17% of participants having another child compared to 33% in the comparison group.

The intervention also demonstrated cost-effectiveness, saving approximately $19,097 for each birth avoided, indicating that the benefits of the program outweigh its costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an intensive, school-based intervention for teen mothers. Key, JD., Gebregziabher, MG., Marsh, LD., et al.[2019]

The UT Teen Health initiative successfully educated community stakeholders and mobilized support for evidence-based teen pregnancy prevention interventions, taking an average of 13.5 months to implement these programs in local schools.

From 2011 to 2015, over 12,500 youth aged 11 to 19 benefited from these interventions, primarily through partnerships with 16 schools, highlighting the effectiveness of school-based programs in reaching large numbers of adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder Education and Community Mobilization Garner Support for Sex Education. Plastino, K., Quinlan, J., Todd, J., et al.[2021]

A systematic review of randomized controlled trials on school-based teen pregnancy prevention programs found that programs including contraceptive information (abstinence-plus) are more effective in reducing teen pregnancy rates compared to abstinence-only programs.

The study highlights the importance of comprehensive sexual education, as it not only addresses abstinence but also equips teens with knowledge about contraceptives, which is crucial for informed decision-making regarding sexual health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based teenage pregnancy prevention programs: a systematic review of randomized controlled trials. Bennett, SE., Assefi, NP.[2018]

Citations

1.

researchgate.net

researchgate.net/publication/270221481_Stepping_Stones_and_Creating_Futures_intervention_Shortened_interrupted_time_series_evaluation_of_a_behavioural_and_structural_health_promotion_and_violence_prevention_intervention_for_young_people_in

(PDF) Stepping Stones and Creating Futures intervention

Stepping Stones and Creating Futures intervention: Shortened interrupted time series evaluation of a behavioural and structural health promotion ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3962027/

Early adolescent pregnancy increases risk of incident HIV ...

A cluster randomized-controlled trial to determine the effectiveness of Stepping Stones in preventing HIV infections and promoting safer ...

3.

researchgate.net

researchgate.net/publication/386020204_Stepping_Stones_A_Thematic_Analysis_Exploring_Beneficiaries_and_Implementers_Perceived_Effectiveness_of_the_13-week_HIV_Education_Program_in_Zambia

Stepping Stones: A Thematic Analysis Exploring ...

Data were analyzed using Atlas.ti (Version 23). Results: Stepping Stones was generally well-received by beneficiaries who highlighted it ...

4.

bmcpublichealth.biomedcentral.com

bmcpublichealth.biomedcentral.com/articles/10.1186/1471-2458-14-1325

Stepping Stones and Creating Futures intervention: shortened ...

We investigated whether combining a broad economic empowerment intervention and Stepping Stones could impact on violence among young men and women.

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/j.1365-3156.2005.01530.x

A cluster randomized‐controlled trial to determine the ...

The aim was to determine the effectiveness of the Stepping Stones behavioural intervention in preventing HIV infections among youth in the rural ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC2505093/

Impact of Stepping Stones on incidence of HIV and HSV-2 ...

Stepping Stones did not reduce incidence of HIV but had an impact on several risk factors for HIV—notably, HSV-2 and perpetration of intimate partner violence ...

7.

srh.bmj.com

srh.bmj.com/content/50/3/195

a systematic review and meta-analysis

This systematic review assesses the use of contraceptives in empowering and strengthening the agency and vice versa among adolescents and young women.