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?

The goal of this randomized trial is to learn if the Stepping Stones (StSt) intervention has a positive impact on the sexual health and relationship behaviors of sexually active youth between the ages of 12 and 22 years old who are at risk for or involved in the legal or child welfare systems. The primary research questions it aims to answer are: * Three months after being offered the intervention, does StSt impact youth's receipt of sexually transmitted infection testing in the past four months? * Nine months after being offered the intervention, does StSt impact youth's frequency of having vaginal and anal sex without condoms in the past four months? * Nine months after being offered the intervention, does StSt impact youth's perpetration of emotional abuse in the past four months? Researchers will compare participants randomized to receive StSt (treatment group) to participants randomized to receive a control condition that contains no sexual or reproductive health information (control group). Participants randomized to the treatment group will be offered StSt as an-person, individual-based intervention delivered over four sessions during a 6-8 week period. Participants randomized to the control group will be offered a virtually delivered control condition.

Will I have to stop taking my current medications?

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

How is the Stepping Stones treatment different from other teen pregnancy prevention treatments?

Stepping Stones (StSt) is unique because it focuses on community mobilization and stakeholder education to support evidence-based interventions, unlike traditional programs that may not prioritize at-risk populations. This approach aims to create a supportive environment for implementing teen pregnancy prevention strategies. ^{1 2 3 4 5}

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

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

Comfortable reading, speaking, and writing in English

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

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]

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]

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 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]

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

Stakeholder Education and Community Mobilization Garner Support for Sex Education. [2021]

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

A program evaluation of the Innovative Teen Pregnancy Prevention Programs (iTP3) Project. [2022]

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

Preventing unwanted adolescent pregnancy: a cognitive-behavioral approach. [2017]

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

Effectiveness of an intensive, school-based intervention for teen mothers. [2019]

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

School-based teenage pregnancy prevention programs: a systematic review of randomized controlled trials. [2018]