Recruiting

Observational Study

Sponsor:

New Jersey Physicians Advisory Group

Code:

NCT05320666

Conditions

Pregnancy in Adolescence

Adolescent Health

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Accepted

Interventions

Yes You Can…Make Smart Choices! (YYC…MSC!) program

Study Details

Brief 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 13 Newark Public Schools in New Jersey, including Weequahic High School and Newark School of Global Studies. 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.

Conditions

Pregnancy in Adolescence

Adolescent Health

Study ID

NCT05320666

Start date

Oct 30, 2023

Status verified date

Nov, 2023

Completion date

Mar 15, 2026

Anticipated

Primary completion date

Jun 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 21

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Yes You Can…Make Smart Choices! (YYC…MSC!) Program

The intervention/treatment participants in the treatment condition will be exposed to NJPAG's YYC...MSC! program. The program is designed to be delivered five days a week for two weeks and contains 11 lessons.

no intervention: Control

The control schools were randomly selected out of a list of eligible schools in the Newark Public School system. Control schools will receive their health class as "business-as-usual" with no additional programming. There is no other place that provides the YYC...MSC! program in which participants could receive programming or information. Also, there are no future plans to provide the control group with the intervention. To our knowledge, there is no other similar programming operating in the Newark Public School area.

Interventions

Yes You Can…Make Smart Choices! (YYC…MSC!) program

The YYC...MSC! is an 11-lesson curriculum that will be delivered to 9th graders in Newark, New Jersey public schools during 40-minute health classes. The curriculum will be delivered in-person over approximately 2 weeks by NJPAG educators. The goal of the program is to prevent teen pregnancy and enhance character development in youth. Each time an NJPAG educator is in the classroom, they will deliver a single lesson of the curriculum. All NJPAG educators have received internal training for the program. The intervention addresses the following adult preparation subjects: parent-child communication, healthy relationships, healthy life skills, adolescent development, and financial literacy.

Primary outcome measure

  • Sexual Activity [ Time Frame: 12-months after pre-survey ]

Central Contacts and Locations

Locations

Arts High School

Recruiting

Newark, New Jersey, United States, 07102

Contacts

American History High School

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Bard High School Early College

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Newark Vocational High School

Recruiting

Newark, New Jersey, United States, 07103

Contacts

West Side High School

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Newark School of Global Studies

Recruiting

Newark, New Jersey, United States, 07104

Contacts

Technology High School

Recruiting

Newark, New Jersey, United States, 07104

Contacts

Newark School of Data Science and Information Technology

Recruiting

Newark, New Jersey, United States, 07106

Contacts

Central High School

Recruiting

Newark, New Jersey, United States, 07108

Contacts

Malcolm X. Shabazz High School

Recruiting

Newark, New Jersey, United States, 07108

Contacts

University High School

Recruiting

Newark, New Jersey, United States, 07108

Contacts

Eagle Academy for Youth Men of Newark

Recruiting

Newark, New Jersey, United States, 07112

Contacts

Weequahic High School

Recruiting

Newark, New Jersey, United States, 07112

Contacts

More Information

Sponsor

New Jersey Physicians Advisory Group

Last update posted

Nov 15, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New Jersey Physicians Advisory Group on 2023-11-15.