Pregnancy in Adolescence
Conditions
Brief summary
A culturally tailored program that creates a safe, open space to increase knowledge, self-efficacy, skills, and comfort related to sexual and reproductive health, including HIV/STI and teen pregnancy prevention, mental health, and substance use risk reduction behavior, and strengthens protective factors, decision-making skills, and connections to trusted adults may help participants chart a path toward optimal health. To address a significant gap in evidence-based, culturally-tailored sexual and reproductive health services for Black and African American adolescents, Public Health Management Corporation (PHMC) is conducting a rigorous evaluation of an innovative group-level, two pronged intervention called Talking Matters using an individual randomized control trial (RCT) design. Due to social distancing guidelines during COVID-19 at the start of the study, all Talking Matters activities, including recruitment, screening, consent, intervention implementation, and data collection, will be conduct virtually and remotely. Developed and piloted over the past two years through FY2018 Phase I New and Innovative Strategies (Tier 2) to Prevent Teen Pregnancy and Promote Healthy Adolescence funding from the Office of Population Affairs (OPA), Talking Matters is a promising group-level, two-pronged intervention tailored for urban Black and African American 14 to 19 year old adolescents who are recruited from school- and community-based settings in Philadelphia, PA. Grounded in Social Cognitive Theory, the Transtheoretical Model, and Self-Determination Theory, and using evidence-based Motivational Interviewing strategies, the primary goals of Talking Matters are to reduce adolescents' risk for teen and unplanned pregnancy, sexually transmitted infections (STIs) and HIV, and to strengthen protective factors improve optimal health. The two prongs of Talking Matters include (1) an adolescent-focused five-session, group-level intervention called We Get to Choose (WGTC) and (2) an adult-focused three-session, group-level training called Let's Talk Real Talk (LTRT). An opportunity to connect WGTC participants to trusted adults who completed LTRT is provided during one facilitated session conducted each quarter. Adult participants of the LTRT training are not human subjects of the Talking Matters study.
Interventions
BEHAVIORALTalking Matters
Group-level, facilitator-led behavioral intervention for 14-19 year old Black and African American adolescents with an intergenerational component to reduce teen pregnancy, strengthen protective factors to improve optimal health, and increase access to trusted adults.
Sponsors
Department of Health and Human Services
Public Health Management Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Individual randomized control trial
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Identifies as Black or African American * 14 to 19 years old at baseline * Lives in Philadelphia, PA * English-speaking * Able to or will be able to obtain access to the internet through a phone, tablet, or computer
Exclusion criteria
* Does not identify as Black or African American * Less than 14 years old or 20 years or older at baseline * Does not live in Philadelphia, PA * Unable to speak or understand English * Unable to access internet through a phone, tablet, or computer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the number of oral, vaginal, and/or anal sex episodes without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up. | Baseline up to 3 months post-baseline | — |
| Change in the number of vaginal sex episodes without any form of contraception (including condoms) in the past 60 days (2 months) from baseline to follow up. | Baseline up to 3 months post-baseline | — |
| Change in the number of partners with whom participants had oral, vaginal, and/or anal sex without a condom, female condom, or dental dam in the past 60 days (2 months) from baseline to follow up. | Baseline up to 3 months post-baseline | — |
| Maintained condom use at last vaginal sex (yes/no) from baseline to follow up. | Baseline up to 3 months post-baseline | — |
| Change in condom use at last vaginal sex (yes/no) from baseline to follow up. | Baseline up to 3 months post-baseline | — |
| Change in self-efficacy for communicating with sexual partners about sexual and reproductive health from baseline to follow up. | Baseline up to 5 weeks post-baseline | Abbreviated Sexual communication self-efficacy scales from The sexual communication self-efficacy scale and Canadian Sexual Health Indicators Survey-Pilot Test And Validation Phase: Final Technical Report. Centre for Communicable Diseases and Infection Control, Infectious Disease Prevention and Control Branch, Public Health Agency of Canada, 2012. (16 of 20 items used) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sexual and reproductive health knowledge from baseline to follow up. | Baseline up to 5 weeks post-baseline | As measured by the number of correct items reported on a 22-item questionnaire comprising modified items from Sexual Transmitted Diseases Knowledge Questionnaire (Jaworski, B. C., & Carey, M. P. (2007). Development and psychometric evaluation of a self-administered questionnaire to measure knowledge of sexually transmitted diseases. AIDS and Behavior, 11(4), 557-574); items from Anderman, E. M., Cupp, P. K., Lane, D. R., Zimmerman, R., Gray, D. L., & O'Connell, A. (2011). Classroom goal structures and HIV and pregnancy prevention education in rural high school health classrooms. Journal of Research on Adolescence, 21(4), 904-922; Section 7 from Cleland, J. (2001). Illustrative questionnaire for interview-surveys with young people. Asking Young People About Sexual and Reproductive Behaviors. Illustrative Core Instruments, Geneva: World Health Organization. |
| Change in attitudes and beliefs about healthy decision making around risk reduction behaviors from baseline to follow up | Baseline up to 5 weeks post-baseline | Abbreviated Making Decisions in Everyday life instrument. from Mincemoyer, C., Perkins, D. F., & Munyua, C. (2005). Measuring the impact of youth development programs: A national on-line youth life skills evaluation system. In The Forum for Family and Consumer Issues (Vol. 10, No. 2). |
| Change in knowledge, expectations, and attitudes about healthy relationships from baseline to follow up. | Baseline up to 5 weeks post-baseline | Abbreviated Healthy Relationship Knowledge, Expectations, and Attitudes domain from the Health Marriage and Relationship Education Models and Measures Project.(Scott, M.E., Moore, K.A., Fish, H., Benedetti, A., & Erikson, S. (2015). Healthy marriage and relationship education: Recommended outcome measures for adolescents. OPRE Report #2015-65a. Prepared by Child Trends. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.) |
| Change in mental health literacy from baseline to follow up. | Baseline up to 5 weeks post-baseline | 18 items scored from 1 to 4 (higher score=higher knowledge) from O'Connor, M., & Casey, L. (2015). The Mental Health Literacy Scale (MHLS): A new scale-based measure of mental health literacy. Psychiatry research, 229(1-2), 511-516. and Self efficacy for stress management from Hansen, W. B., & McNeal Jr, R. B. (1997). How DARE works: An examination of program effects on mediating variables. Health education & behavior, 24(2), 165-176. |
| Change in intentions to use condoms from baseline to follow up. | Baseline up to 5 weeks post-baseline | Sakeah, J. K. (2017). Determinants of Condom use intentions among University students in Ghana (Doctoral dissertation, Lethbridge, Alta: University of Lethbridge, Faculty of Health Sciences). |
| Change in self-efficacy for communicating with trusted adults about sexual and reproductive health from baseline to follow up | Baseline up to 5 weeks post-baseline | Modified Parent-Teen Communication About Premarital Sex from Jaccard, J., Dittus, P. J., & Gordon, V. V. (2000). Parent-teen communication about premarital sex: Factors associated with the extent of communication. Journal of Adolescent Research, 15(2), 187-208. |
| Change in self-efficacy for using condoms from baseline to follow up. | Baseline up to 5 weeks post-baseline | Abbreviated condom use self-efficacy scale from Asante, K. O., & Doku, P. N. (2010). Cultural adaptation of the condom use self efficacy scale (CUSES) in Ghana. BMC public health, 10(1), 1-7. (12 of 14 items used) |
Countries
United States
Outcome results
None listed