An Evaluation of the Yes You Can... Make Smart Choices Curriculum

NCT05320666 | Recruiting

• 1 other identifier: NJPAG12131922E
• Study Type: interventional
• Target: 2,600
• Locations: 1 country
• Sites: 13

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

Outcome Measures

Primary Outcomes (1)

• Sexual Activity

  Individual participants: Survey - sexual intercourse in the last 3 months. 1-item measure asking participants how many times they engaged in sexual intercourse in the past 3-months recoded to a dummy variable (1 = had sex in the last 3-months, 0 = did not have sex in the last 3-months)

  12-months after pre-survey

Secondary Outcomes (18)

• Sexual Activity 1

  3-months after pre-survey, 12-months after pre-survey

• Sexual Activity 2

  3-months after pre-survey, 12-months after pre-survey

• Intent to Engage in Sexual Activity 1

  Post-survey, 3 months after pre-survey, 12 months after pre-survey

• Intent to Engage in Sexual Activity 2

  Post-survey, 3 months after pre-survey, 12 months after pre-survey

• Sexual Risk Avoidance Intent 1

  Post-survey, 3 months after pre-survey, 12 months after pre-survey

Study Arms (2)

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

EXPERIMENTAL

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.

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

Control

NO INTERVENTION

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 BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• New Jersey Physicians Advisory Group: lead
• AMTC & Associates: collaborator

Study Sites (13)

Arts High School

Newark, New Jersey, 07102, United States

RECRUITING

American History High School

Newark, New Jersey, 07103, United States

RECRUITING

Bard High School Early College

Newark, New Jersey, 07103, United States

RECRUITING

Newark Vocational High School

Newark, New Jersey, 07103, United States

RECRUITING

West Side High School

Newark, New Jersey, 07103, United States

RECRUITING

Newark School of Global Studies

Newark, New Jersey, 07104, United States

RECRUITING

Technology High School

Newark, New Jersey, 07104, United States

RECRUITING

Newark School of Data Science and Information Technology

Newark, New Jersey, 07106, United States

RECRUITING

Central High School

Newark, New Jersey, 07108, United States

RECRUITING

Malcolm X. Shabazz High School

Newark, New Jersey, 07108, United States

RECRUITING

University High School

Newark, New Jersey, 07108, United States

RECRUITING

Eagle Academy for Youth Men of Newark

Newark, New Jersey, 07112, United States

RECRUITING

Weequahic High School

Newark, New Jersey, 07112, United States

RECRUITING

Central Study Contacts

Debbie Marchione

CONTACT

908-322-9050; debbie@njphysicians.org

Peggy Cowan

CONTACT

908-322-9050; pcowan@njphysicians.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder and CEO

Model Details: 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. YYC…MSC! is delivered like a traditional classroom curriculum, including lectures and activities, meaning all students in a given classroom will receive the lectures concurrently. The intervention addresses the following adult preparation subjects: parent-child communication, healthy relationships, healthy life skills, adolescent development, and financial literacy.

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 11, 2022
• Study Start: October 30, 2023
• Primary Completion: June 15, 2025
• Study Completion: March 15, 2026
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)