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Completed
NCT05320666
An Evaluation of the Yes You Can... Make Smart Choices Curriculum
Conditions: Pregnancy in Adolescence, Adolescent Health
Sex: All
Ages: 10 Years – 21 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 2600
Sponsor: New Jersey Physicians Advisory Group
Location: Arts High School Newark New Jersey
Summary
The New Jersey Physicians Advisory Group (NJPAG) previously created the Yes You Can…Make Smart Choices! (YYC…MSC!) program with the goal of preventing teen pregnancy and enhancing character development in youth. YYC…MSC! is a fully developed intervention that NJPAG has experience implementing that is grounded in a theoretical framework with promising evidence of effectiveness. However, this intervention has not yet undergone a rigorous evaluation with a control or comparison group. This evaluation aims to conduct a randomized control trial (RCT) to determine the program's effectiveness. This evaluation will focus on the entire PREIS planned intervention, YYC…MSC!. The intervention will be implemented in 12 Newark Public Schools in New Jersey. Findings from this study will expand the evidence base on adolescent pregnancy prevention through this innovative program. After the study, findings will be disseminated to encourage program interest, support, and adoption in real-world service systems or communities, including schools.
The primary research question is, "What is the effect of the 2-week YYC…MSC! program on 9th grade students in Northeast urban school districts' reports of engaging in sexual intercourse 12-months after the pre-survey compared to those that do not receive the program?" The outcome for the primary research questions is sexual intercourse in the last 3 months and the domain is sexual activity.
Eligibility Criteria
Youth served and recruited will be limited to 9th graders from health classrooms at the NPS sites participating in this program who do not have severe cognitive, mental, or behavioral impairments. Students with an Individual Education Plan (IEP) who are in a restricted placement due to such issues will not be able to participate in the program as they will not be a part of the mainstream classrooms where the program will take place. Students with an IEP who are placed in regular classroom settings (i.e., mainstreamed) will be included in the program.
New Jersey law only requires passive parental consent to be obtained, using a written notice about the evaluation provided to students to bring home with an option for parents to sign the notice to opt their child/student out of the evaluation. If parents wish to opt their child/student out of the evaluation, the child will still receive the program because it is the Newark Board of Education-approved sexual education curriculum treatment group health classes. When the Educator goes back to the classroom to pre-survey, they will collect any 'opt-out' notices and survey only those students whose parents have not elected to 'opt-out' their child.
Ineligible students include students with IEP who are in a restricted placement and students that bring back 'opt-out' written notices. Since we are using the same form for treatment and control schools (making it unclear to parents what group their child is in), we do not expect differences in opt-out rates between treatment and control schools.
Source: ClinicalTrials.gov (NCT05320666). StuddyBuddy aggregates publicly available trial information.