Unstained Program for Teen Pregnancy Prevention

Recruiting in Palo Alto (17 mi)

Overseen by Sarah Walsh, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The Policy & Research Group

Disqualifiers: Pregnancy, Incarceration, Other study, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this randomized trial is to learn if the Unstained intervention has a positive impact on the sexual health behaviors of sexually active youth between the ages of 14 and 19 years old who are at risk for or involved in the juvenile justice system. The primary research questions it aims to answer are: * Three months after being offered the intervention, does Unstained impact youth's receipt of sexually transmitted infection testing in the past four months? * Nine months after being offered the intervention, does Unstained impact youth's frequency of having vaginal and anal sex without condoms in the past four months? Researchers will compare participants randomized to receive Unstained (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 Unstained as a virtual, individual-based intervention delivered during three \~60 minute sessions over a 3-6 week period. Participants randomized to the control group will be offered a virtually delivered control condition.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Unstained for teen pregnancy prevention?

The effectiveness of the Unstained treatment for teen pregnancy prevention may be supported by similar programs that emphasize abstinence, decision-making skills, and access to contraceptive services, which have shown to reduce sexual initiation and increase contraceptive use among adolescents. ^{1 2 3 4 5}

How does the Unstained treatment for teen pregnancy prevention differ from other treatments?

The Unstained treatment is unique because it combines sexual education, life skills development, and academic support, which are shown to be effective in reducing teen pregnancies. Unlike other programs that may focus solely on abstinence or contraceptive access, this comprehensive approach addresses multiple aspects of a teenager's life to prevent pregnancy. ^{6 7 8 9 10}

Eligibility Criteria

This trial is for sexually active youth aged 14-19 who are at risk for or involved in the juvenile justice system. To join, they must not have received comprehensive sexual health education before.

Inclusion Criteria

United States resident

Owns or has regular access to a personal device with internet access

Comfortable reading, speaking, and writing in English

Exclusion Criteria

Currently trying to start a pregnancy

Currently in jail or being detained in a facility

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Unstained intervention as a virtual, individual-based intervention delivered during three ~60 minute sessions over a 3-6 week period

3-6 weeks

3 virtual sessions

Follow-up

Participants are monitored for changes in sexual health behaviors and STI testing

11 months

3 assessments (baseline, 5 months, 11 months post-baseline)

Treatment Details

Interventions

• Unstained (Behavioral Intervention)

Trial Overview The study tests 'Unstained', a virtual intervention aimed at improving sexual health behaviors. It's compared to a control with no sex education content. Participants receive either Unstained or the control randomly over several sessions.

Participant Groups

Group I: Unstained Experimental Treatment 1 Intervention

Group II: Like Placebo Group 1 Intervention

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Policy & Research Group New Orleans, LA

Who Is Running the Clinical Trial?

The Policy & Research Group Lead Sponsor

PCI Media Collaborator

Reproductive Health National Training Center Collaborator

Department of Health and Human Services Office of Population Affairs Collaborator

Mathematica Policy Research, Inc. Collaborator

References

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

A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program. [2019] To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy.

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

The effect of an educational approach to pregnancy prevention among high-risk early and late adolescents. [2014] To evaluate a novel approach to adolescent pregnancy prevention through scheduled educational clinic visits, focusing to retain patients within the clinic system.

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

Pregnancy prevention among urban adolescents younger than 15: results of the 'In Your Face' program. [2006] Data from a pregnancy prevention program operating through school-based clinics in four New York City junior high schools suggest that an intensive risk-identification and case-management approach may be effective among very young adolescents. Among students given a referral to a family planning clinic for contraception, the proportion who visited the clinic and obtained a method rose from 11% in the year before the program began to 76% in the program's third year. Pregnancy rates among teenagers younger than 15 decreased by 34% over four years in the program schools. In the fourth year of the program, the pregnancy rate in one school that was unable to continue the program was almost three times the average rate for the other three schools (16.5 pregnancies per 1,000 female students vs. 5.8 per 1,000).

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

Understanding the impact of effective teenage pregnancy prevention programs. [2022] A review of five rigorously evaluated adolescent pregnancy prevention programs shows that all five incorporate an emphasis on abstinence or delay of sexual initiation, training in decision-making and negotiation skills, and education on sexuality and contraception. Four of the five directly or indirectly provide access to contraceptive services. Comparisons between treatment and control groups show that all four programs that measured changes in rates of sexual initiation among adolescents had a significant effect on that outcome, reducing the proportion of adolescents who initiated sexual activity by as much as 15 percentage points; the programs were most successful when they targeted younger adolescents. Three of these four programs also significantly increased rates of contraceptive use among participants relative to controls; the most successful programs, which increased contraceptive use by as much as 22 percentage points, provided access to contraceptive services and targeted adolescents who were younger and those who were not yet sexually experienced. Two programs significantly decreased the proportion of adolescents who became pregnant; these programs were the two that were most active in providing access to contraceptive services.

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

Perinatal outcomes in a school-based program for pregnant teen-agers. [2019] Teen-age pregnancy constitutes a high-risk factor for prematurity, low birth weight, intrauterine growth retardation, infant mortality, and later health, behavioral, developmental, and educational disadvantages. A case-controlled study was performed to evaluate the influence of the Teen-age Parent Center on pregnancy outcomes. Improved outcomes were identified for low-birth-weight rate, high school graduation rate, smoking during pregnancy, and prenatal care. These results indicate that a comprehensive, school-based program can enhance perinatal outcomes.

6. Netherlands pubmed.ncbi.nlm.nih.gov

Economic evaluation of a comprehensive teenage pregnancy prevention program: pilot program. [2021] Previous research has suggested that comprehensive teenage pregnancy prevention programs that address sexual education and life skills development and provide academic support are effective in reducing births among enrolled teenagers. However, there have been limited data on the costs and cost effectiveness of such programs.

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

Strong, smart and bold strategies for improving attendance and retention in an after-school intervention. [2014] The Volunteers of America Greater Los Angeles (VOALA) Girls Inc. program is implementing and rigorously evaluating its Preventing Adolescent Pregnancy curriculum as part of a demonstration grant to identify effective teen pregnancy prevention programs sponsored by the U.S. Department of Health and Human Services Office of Adolescent Health (OAH). A total of 517 participants from Title I urban middle and high schools were randomly assigned to either Preventing Adolescent Pregnancy (treatment) or Economic Literacy (control) in two cohorts. Programming occurred after school weekly at middle and high schools. Low attendance and loss of sample (attrition) are common challenges in after-school programming, negatively affecting both the ability of a program to be successful and the integrity of a randomized controlled trial. The current article discusses challenges encountered with recruitment, incentives, and school factors during a first cohort of youth and innovative implementation changes during a second cohort that resulted in increased attendance rates and decreased attrition rates. Commentary is provided by the OAH Project Officer as well as lessons learned after 2 years of implementing the program.

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

"Be smart, be safe, be sure". The revised Pregnancy Prevention Program for women on isotretinoin. [2013] After studying the information in this article, the reader should be able to: 1. Describe the purpose of the pregnancy prevention program. 2. Discuss the five most common reasons for unintended pregnancy. 3. List the components of the expanded pregnancy prevention program. Preventing unintended pregnancy is currently an unsolved problem in the United States, especially among teens. However, successful programs to minimize unintended pregnancy do exist and can serve as a model for other efforts. One such program is the Pregnancy Prevention Program, for use when prescribing isotretinoin to women with childbearing potential. Isotretinoin is a known teratogen and is prescribed disproportionately to teens, who are at higher risk of unintended pregnancy. The program has shown impressive effectiveness despite these handicaps, but since exposure to isotretinoin is so harmful to the fetus and some women still become pregnant while taking the drug, the program has been revised to reduce the failure rate further.

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

Adolescent health services and contraceptive use. [2018] A pilot study of a health services program for never-pregnant high-school students, which stresses development of incentives for personal involvement in their own health care, reports a low incidence of unintended pregnancy among girls who requested contraceptives. The social and emotional characteristics of those who continued contraceptive use are compared with the small group who had uninteneded pregnancies.

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

A public health success: understanding policy changes related to teen sexual activity and pregnancy. [2006] Teenage pregnancy prevention has long been on the American public health agenda. Over the past decade, a number of concurrent federal, state, and local policies have responded to the myriad and diverse needs of adolescents, from supporting adolescents who have not initiated sexual intercourse to strategies aimed at avoiding a repeat pregnancy among teenage parents. Key policies, including comprehensive family life education, access to contraceptive care, and youth development, have resulted in delays in sexual debut, improved contraceptive use, and have achieved reductions in pregnancies, abortions, and births. Although improvements are documented across all ethnic and racial subgroups, substantial health disparities continue to exist. Synergistic policy approaches represent a substantial change from the past when narrow, single-issue strategies were adopted and were limited in their effectiveness. Renewed efforts to implement narrow policy approaches (e.g., abstinence-until-marriage or restrictions to contraceptive access) need to be considered in light of existing research findings.