Adolescent Behavior, Pregnancy Related, Sexually Transmitted Diseases
Conditions
Brief summary
This study is a 2-arm cluster randomized controlled trial with approximately 1,200 youth aged 14-19 years to assess the effectiveness of Yes and Know, a sexual health education program. To be eligible, participants must be 14-19 years old and English-speaking. Those in the treatment arm will receive Yes and Know, a synchronous virtual program delivered over multiple sessions totaling nine hours, along with asynchronous online activities and resources. Those in the control arm will receive a similarly structured program focused on nutrition education. Participants will complete brief online surveys at baseline and at 3 and 12 months after the synchronous sessions. The study will assess the program's effectiveness in reducing the prevalence of unprotected sex among youth and improving short-term outcomes, such as knowledge of reproductive health and healthy relationships, self-efficacy, and the use of reproductive health services.
Detailed description
For the Yes and Know study, cohorts of 5-25 participants will be recruited and randomized into one of the two study conditions: Yes and Know: Life Skills intervention (intervention condition) or Yes and Know: Nutrition Skills intervention (comparison condition). The programs will be delivered by trained health educators through synchronous virtual sessions. Participants can access the supplemental resources and activities for their respective programs on the program's website. Participants will be recruited by local community partners (with a focus on rural communities in the South and Southeast regions of the United States) as well as paid advertising on social media platforms. Young people must have consent and provide their assent to be part of the study. Yes and Know: Sexual Health and Life Skills covers sexual and reproductive health, healthy relationships, life skills, and educational and career success. Yes and Know: Nutrition Skills covers learning to make healthy decisions about food, weight and disordered eating, and creating nourishing meals. Both programs consist of nine 60-minute synchronous group sessions, totaling nine hours, to be taught at least once a week (or more frequently depending on cohort scheduling).
Interventions
BEHAVIORALYes and Know curriculum
Yes and Know is fully virtual intervention that integrates group-based education with digital tools to support young people ages 14 to 19 by increasing their relationship and healthy life skills. The curriculum focuses on sexual and reproductive health; healthy relationships; life skills; and educational and career success. It is delivered over nine synchronous sessions of 60-minutes each for a duration of nine hours, plus asynchronous online resources and activities.
BEHAVIORALNutrition Education for Adolescents
Youth will receive a fully virtual intervention that integrates group-based education with digital tools focused on adolescent nutrition and wellness. The curriculum is delivered over nine synchronous sessions of 60-minutes each for a duration of nine hours, plus asynchronous online resources and activities.
Sponsors
ETR Associates
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Ages 14-19; and * English speaking.
Exclusion criteria
\- Anyone not meeting inclusion criteria.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of unprotected vaginal or anal sex | 12 months post-intervention | Single measure constructed from the number of times had vaginal sex without a contraceptive method in the past 3 months; number of times had anal sex without a condom in the past 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of sexual and reproductive health services in the past 3 months | 12 months post intervention | Single dichotomous (yes/no) measure of whether the participant received any sexual or reproductive health services from a health care provider in the past 3 months, including condoms or other contraceptive methods, STI/HIV testing, prenatal care, or sexual health information. |
| Sexual and reproductive health knowledge | 3 months post intervention | A measure of the % of correct answers (0% to 100%) on six survey questions that assess knowledge of sexual and reproductive health, developed for the study |
| Positive attitudes towards sexual consent | 3 months post intervention | A measure comprised of 3 questions that assesses positive attitudes towards sexual consent. Scale scores range from 3 to 15 based on a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree). |
| Self-efficacy in relationship communication | 3 months post intervention | A measure comprised of 5 questions that assesses perceived self-efficacy in healthy relationship communication. Scale scores range from 5 to 25 based on a 5-point Likert scale (1 = not at all confident, 5=very confident). |
| Self-efficacy in using condoms correctly | 3 months post intervention | A measure comprised of 3 questions that assesses perceived self-efficacy in using condoms correctly. Scale scores range from 5 to 25 based on a 5-point Likert scale (1 = not at all confident, 5=very confident). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRebecca A Braun, DrPH, MPH
ETR Associates
PRINCIPAL_INVESTIGATORPamela Anderson, PhD
ETR Associates
Outcome results
None listed