Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05320666 |
| Other study ID # |
NJPAG12131922E |
| Secondary ID |
NJPAG12131922E |
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 30, 2023 |
| Est. completion date |
March 15, 2026 |
Study information
| Verified date |
November 2023 |
| Source |
New Jersey Physicians Advisory Group |
| Contact |
Debbie Marchione |
| Phone |
908-322-9050 |
| Email |
debbie[@]njphysicians.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Introduction
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.
Intervention Activities
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. The PREIS funding is
supporting the implementation and evaluation of the program. 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; their training includes: (1) studying the
curriculum and completing activity/learning pages, (2) practicing teaching to other educator
in a mock classroom setting, followed by feedback from the team, (3) observing a seasoned
educator teaching the curriculum in its entirety, (4) co-teach the curriculum with a seasoned
educator, and (5) teaching on their own, with observation. 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.
Logic Model
See Appendix A for the intervention logic model. Since its inception in 2004, NJPAG has been
a non-profit in New Jersey with the goal of addressing the societal problems of teen
pregnancy, teen STDs/STIs, and single-parent teen families. To meet this goal, NJPAG has
created various curricula to educate youth in New Jersey and beyond, including the YYC…MSC!
curriculum for this intervention. NJPAG has a positive, existing relationship with the Newark
Public Schools (NPS) Board of Education. As a result of this relationship, NJPAG has the
approval to provide the intervention as part of all NPS's 9th-grade health classes. Schools
with potentially high rates of language barriers were eliminated because the program is only
taught in English. After eliminating schools with potentially high rates of language
barriers, 13 NPS schools were selected to participate in the evaluation, five control
schools, and five treatment schools.
Internally, NJPAG has a Board of Directors, Executive Director, Program Director, and
educators. After receiving training, NJPAG educators will go into Newark public high schools
to build rapport with the school's teachers, staff, and students and explain the intervention
and related processes. Once rapport is built, NJPAG will go to classes and disseminate the
written notice form for youth to bring home to parents to inform parents of the program their
child/student will receive and give the parents the option to opt their child/student out of
the evaluation. Two weeks after the written notice is disseminated, an Educator will go back
to the classroom and collect any forms returned by parents who opted their child out of the
evaluation. Upon receiving opt-outs, an educator will facilitate the pre-survey. The
following school day after the pre-survey, the educator will go back to the classroom to
begin program delivery, starting with lesson 1 and subsequently teaching a lesson every time
they go to the classroom. Each lesson addresses a different topic related to pregnancy
prevention and has lesson goals.
We expect all lessons to work together to achieve the program goal. For intermediate
outcomes, we expect that treatment school youth, e.g., those that receive the intervention,
will report an increase in pregnancy prevention knowledge, skills, and confidence and a
decrease in activity that could lead to unwanted pregnancy. We believe this intervention will
impact youth who received the program long-term by improving life skills, such as emotional
coping and sexual, cognitive, and social health, decreasing incidences of unwanted pregnancy,
decreasing incidences of STIs, and enhancing character development.
Target Population
NJPAG has been serving New Jersey public schools for almost two decades. Recently, NJPAG was
approved to provide sex education programming to 9th-grade health class students in NPS by
the Newark Board of Education.
The target population is youth in 9th grade in urban school districts in the Northeast region
without any severe cognitive, mental, or behavioral impairments.
The total population of youth who would receive the intervention is approximately 2,000
students. The average expected age of participants is 14. Consistent with the NPS district
student population race/ethnicity breakdown, the expected race/ethnicity breakdown of
participants is as follows: Black (38.8%), Hispanic (51.0%), White (8.4%), Asian (< 1%),
Native Hawaiian/ Pacific Islander (< 1%), American Indian (< 1%), Unspecified (< 1%).
Research Questions
The intervention being tested is the YYC…MSC! program and the target population are youth in
9th grade in urban school districts in the Northeast region without any severe cognitive,
mental, or behavioral impairments. The counterfactual condition is business as usual for
control schools. The intervention occurs over 11 consecutive school days in health classes.
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.
There are 12 secondary research questions; including (1) What is the effect of the 2-week
YYC…MSC! program on 9th grade students in Northeast urban school districts' reports of
engaging in oral sex compared to those that do not receive the program? [domain: sexual
activity, outcome: oral sex], (2) What is the effect of the 2-week YYC…MSC! program on 9th
grade students in Northeast urban school districts' reports of intent to engage in sexual
activity compared to those that do not receive the program? [domain: intent to engage in
sexual activity, outcome: intent to engage in sexual activity], (3) What is the effect of the
2-week YYC…MSC! program on 9th grade students in Northeast urban school districts' reports
intent to consistently use contraception compared to those that do not receive the program?
[domain: sexual risk avoidance intent, outcome: consistent contraception use], (4) What is
the effect of the 2-week YYC…MSC! program on 9th grade students in Northeast urban school
districts' reports of having unprotected sex compared to those that do not receive the
program? [domain: sexual risk avoidance, outcome: unprotected sex], (5) What is the effect of
the 2-week YYC…MSC! program on 9th grade students in Northeast urban school districts'
reports of increased financial literacy compared to those that do not receive the program?"
[domain: life skills, outcome: financial literacy], (6) What is the effect of the 2-week
YYC…MSC! program on 9th grade students in Northeast urban school districts' knowledge of
HIV/STDs/STIs compared to those that do not receive the program? [domain: sexual health
knowledge, outcome: knowledge of HIV/STIs/STDs], (7) What is the effect of the 2-week
YYC…MSC! program on 9th grade students in Northeast urban school districts' reports of their
ability to resist negative pressures to have sex compared to those that do not receive the
program? [domain: sexual risk avoidance skills, outcome: skills to resist pressure], (8) What
is the effect of the 2-week YYC…MSC! program on 9th grade students in Northeast urban school
districts' reports of future orientation and setting life goals compared to those that do not
receive the program? [domain: life skills, outcome: goal setting], (9) What is the effect of
the 2-week YYC…MSC! program on 9th grade students in Northeast urban school districts'
reports of healthy life skills compared to those that do not receive the program? [domain:
life skills, outcome: healthy life skills], (10) What is the effect of the 2-week YYC…MSC!
program on 9th grade students in Northeast urban school districts' knowledge of healthy
relationships compared to those that do not receive the program? [domain: life skills,
outcome: healthy relationships], (11) What is the effect of the 2-week YYC…MSC! program on
9th grade students in Northeast urban school districts' increased communication skills
compared to those that do not receive the program? [domain: life skills, outcome:
communication], and (12) What is the effect of the 2-week YYC…MSC! program on 9th grade
students in Northeast urban school districts' engaging in sexual intercourse 3-months after
the pre-survey? [domain: sexual activity, outcome: sexual intercourse in the last 3-months].
Conflicts of Interest
There are no conflicts of interest. Treatment and Comparison Conditions
Treatment Condition
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 (see Table 1 for lessons and goals).
Control/Comparison Condition
The control schools were randomly selected out of a list of eligible schools (a total of 13
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.
Sample Identification, Selection, and Retention
The YYC… MSC! program is approved as the Newark Board of Education sexual education
curriculum. All 9th graders in the 13 selected NPS schools will be asked to participate in
the evaluation. Newark public schools with a high percentage of English Language Learners
(ELL) students since the program is only provided in English. Participants will be identified
by being in a school that is randomly assigned to be a treatment school. Ninth graders in
participating NPS treatment schools will receive the YYC…MSC! program.
Program attrition is predicted to be minimal, given it is a school-based program. However,
attrition is likely for students who move out of the district or to another school within the
district. To try to reach students that move, we are collecting contact information (phone
number and personal email address) on our enrollment form. Cluster-level attrition is
predicted to be unlikely given the rapport NJPAG has previously built with the Newark Public
Schools individually and as a district.
Anticipated Sample Size
We currently have 13 public schools that are engaged in this study, five that will be
randomly assigned to the treatment group and five that will be randomly assigned to the
control group. On average, there are four health classes in each school, each of which has
approximately 25 students. Therefore, each year we will enroll approximately 1,000 students
in the study (25 x 4 x 10 = 1,000); 500 in the treatment group and 500 in the control group.
Unless we are able to recruit more schools (we are currently having conversations with
several charter schools in the Newark School District), we anticipate having to run the study
for two full years, in order to meet the sample size requirements needed to achieve adequate
power. We will then have 2,000 students enrolled in the study (1,000 in the treatment group
and 1,000 in the control group).
Identification and selection of clusters (if applicable)
The 13 eligible Newark Public Schools were selected as clusters. There is only one
exclusionary criterion for schools, and that is a high percentage of ELL students because the
program is only offered in English. Given the buy-in from the Newark Board of Education,
recruiting schools is not anticipated to be a problem. NJPAG has started building rapport
with the department chairs at each of the participating schools. The level of randomization
is at the school-level, meaning we will randomly assign each of the 13 schools to either
treatment or control. Random assignment will be conducted using a random number generator
from 0-1 in Excel. After generating random numbers, the 13 schools will be ordered based on
their number assignment and the five with the smallest number will be assigned control and
the five with the highest number will be assigned treatment. All students included in the
impact analysis will be students of the participating schools prior to random assignment.
Students will be notified of their schools' random assignment after the parental written
notice is distributed and enrollment is completed.
Identification and selection of individuals
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.
Given NJPAG's relationship with the Newark Board of Education, recruitment of schools is not
expected to be challenging. NJPAG will contact each of the eligible schools to communicate
about the program, program delivery, and the timeline. Schools will be randomized and
maintain their randomization category for the entirety of the evaluation for pragmatic
reasons (e.g., NJPAG-school communication, building rapport, etc.). After randomization,
NJPAG Educators will go into schools to tell the students about the evaluation. Students at
this time will not know if they are receiving the program. Following that, students are told
to bring home the written notice and provide it to their parents for the option to opt out of
the evaluation. For each school, the timeline goes as follows: Educator goes into school and
health classes to disseminate the written notice for youth to bring home to their parents,
the Educator comes back 2 weeks later to pre-survey all participating youth, the next school
day the Educator comes back to start the program and consistently teaches a lesson for the
next 11 school days, the next school day a different Educator goes into the school health
classes to collect post-survey data, 3-months after the pre-survey date a different Educator
goes into the school health classes to collect follow-up data, and 12-months after the
pre-survey date a different Educator goes into the school health classes to collect follow-up
data.
For the current study, no program enrollment is necessary because the NPS Board of Education
approved the YYC…MSC! program as a designated sexual health curriculum for 9th graders.
Therefore, all students in NPS treatment sites will be automatically enrolled in the program;
but parents can opt their child out of the evaluation. Evaluation enrollment will be obtained
via parental opt-out forms.
The process for each cohort is the following: NJPAG Educator goes into school, tells youth
about the program and evaluation, and disseminates parental written notices.
1. Educators collect any 'opt-out' notices that were returned.
2. All participating students take the pre-survey.
3. Students receive full YYC…MSC! Programming.
4. All participating students take the post-survey. Follow-Up
5. Participating students take a follow-up survey 3-months after the pre-survey date.
6. Participating students take a follow-up survey 12 months after the pre-survey date.
Tracking and Retention of Individuals
Because the YYC…MSC! program was approved by the Newark Board of Education as a sex education
program for NPS 9th graders required health classes; program dosage and attendance will be
consistent with students' health class attendance. For follow-up data collection, NJPAG
Educators will go back into the school building and pull participating students from their
classes to participate in follow-up surveys. If a given participant is not there when the
NJPAG Educator goes back to the school to collect follow-up data, we will communicate with
the school district contact to attempt to locate the participating students to survey them at
their new school. If a participating student moves out of the Newark school district, we will
contact them via phone or email and ask them to participate in the survey. The anticipated
response rate for each round of data collection is as follows: pre-survey (95%), post-survey
(85%), three months (80%), and 12 months (70%).
Data Collection
Data Collection Plan
Participants in the treatment group will be determined to have completed their engagement in
the intervention if they received 80% of the program lessons (e.g., 9 out of 11). The data
collection window for each time point is two weeks. The data collection window will be
managed by reviewing participants' timestamp (e.g., the time and date they started the
survey) on their survey completion. There are no costs associated with measures because they
were all created for this project specifically.
The timing of data collection for the pre-survey is before the first lesson is administered,
approximately 2 weeks after disbursing the written notice for students to bring home to their
parents. The post-survey is collected immediately following the completion of the program.
The 3-month follow-up survey is collected 3-months from the pre-survey date. The 12-month
follow-up is collected 12-months from pre-survey.
Data Security & Privacy
Survey data collection will be captured electronically via Alchemer.com, ensuring the quality
and security of both data collection and data storage. Individual-level federal reporting and
tracking data is captured and stored on AMTC & Associates Online Participant Tracking System
(OPTS) (further security information can be found below). Data collectors are trained in the
protection of human subjects and best practices for successful data collection.
Electronic surveys will be collected using online surveys from Alchemer.com. Alchemer is
committed to ensuring the quality and security of its data collection software and has robust
monitoring software used to monitor performance and notify any issues.
All staff working with Personally Identifiable Information (PII) and sensitive data complete
training on the program policy and sign a confidentiality form agreeing not to share
participant-level PII or sensitive data. Access to data will only be granted to project staff
who need access and sign a confidentiality agreement such as staff responsible for data
collection, entry and/or electronic or hard copy transmission; these staff must be trained on
and sign the receipt of this policy and confidentiality agreement. Those who may only need
limited access will be trained and will sign the receipt of the policy. Limited access to
data may include only having access to the necessary data to understand the number of
responses for each school, class, and teacher. For example, facilitators may collect
attendance data but may not need access to survey data, and yet attendance data may be
related to sensitive data. Additionally, identifiable data from surveys will only be
available to the analysts tasked with de-identifying the data. Documents containing PII
(e.g., completed parent consent forms) will be saved on a secure computer server away from
survey data. Data will be de-identified. To link entry, exit, and follow-up surveys, a
pseudo-ID will be created by asking the youth for their first and last initials, birth month,
and birth date on each survey administered. These individual survey items will be
concatenated to create a unique ID for each respondent.
If a data breach occurs, Evaluators will notify NJPAG, pause data collection, identify any
vulnerable parties, fix any issues resulting from a breach, and ensure any improperly shared
information is deleted.
Analysis Plan
All analyses will be conducted using SPSS. Outliers will be identified as three standard
deviations above the mean and removed from the data. When appropriate, missing data will be
handled by using mean imputation. This will only occur when feasible. For example, if
participants have skipped over a subset of items on a particular measurement scale, we can
use mean imputation for their missing data. However, we will be unable to use mean imputation
for behavioral outcomes that are only measured by a single item. Participant data will be
utilized for analyses if they completed 75% of scale items within a given scale. We will use
categorial data analysis, such as logistic regression, to analyze any outcomes that are
measured using a single item. We will use multiple regression to analyze outcomes that are
measured using multiple items. Baseline/pre-survey data will be used as a covariate in all
models . Level 1 covariates include race, gender, age, and sexual orientation. There is one
Level 2 covariate, school size.
