NCT03240887

Brief Summary

A randomized controlled trial is being conducted in high schools in North Carolina and New York City to determine the impact of a school-based, positive youth development program on sexual behaviors associated with teen pregnancy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,523

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

2.9 years

First QC Date

July 27, 2017

Last Update Submit

November 16, 2022

Conditions

Keywords

Teen pregnancy prevention

Outcome Measures

Primary Outcomes (3)

  • Sexual initiation

    The measure is operationalized as a dichotomous outcome, where 1 = participant has had sex, 0 = participant has never had sex. One questionnaire item measures sexual initiation: Have you ever had any type of sex (oral, vaginal, or anal)?

    1 year after baseline, or the beginning of the 10th grade

  • Frequency of sex

    The outcome is operationalized as the count of the number of times a participant reports having had any type of sex in the past 3 months. One questionnaire item measures frequency of sex: In the past 3 months, how many times have you had any type of sex?

    1 year after baseline, or the beginning of the 10th grade

  • Number of sexual partners

    The outcome is operationalized as the count of the number of sexual partners a participant reports having in the past 3 months. Two questionnaire items are used to measure the number of sexual partners questions. The first item asks the participant with whom they have had sexual contact during their life, and if sexual contact with any gender is reported, the second item subsequently asks how many sexual partners they have had in the past three months.

    1 year after baseline, or the beginning of the 10th grade

Study Arms (2)

Peer Group Connection (PGC)

EXPERIMENTAL

Ninth-grade participants are assigned to small groups of 10-14 students that attend weekly peer group outreach sessions led by older peer leaders.

Behavioral: Peer Group Connection

Business as usual

NO INTERVENTION

Ninth grade students remain in their regularly scheduled school classes or activities during PGC outreach times.

Interventions

Faculty advisors at each participating high school are trained to run the program and teach a daily leadership course to peer leaders. Eleventh and twelfth-grade peer leaders who participate in the daily leadership development class facilitate outreach sessions with their assigned group of ninth graders. PGC can be offered in either a half-year (semester) or full-year format. In either format, a minimum of 18, 45-minute outreach sessions are expected to be offered to PGC participants during the course of their ninth-grade year. Outreaches are created to facilitate the transition to high school and encourage students to attend school, set goals for themselves, and make healthy decisions.

Peer Group Connection (PGC)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be enrolled at a study school
  • Provide parental consent and personal assent to participate in the study
  • Meet basic requirements for data collection (students must have the ability to complete a self-administered Participant Questionnaire, which is available in English and Spanish, in a classroom or group setting, unassisted, in 60 minutes or less.)
  • Be entering the ninth grade for the first time.

You may not qualify if:

  • Be intending to enroll in a non-study school in ninth grade.
  • Be repeating ninth grade.
  • Be unable to complete the questionnaire without assistance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Policy & Research Group

New Orleans, Louisiana, 70118, United States

Location

Study Officials

  • Eric Jenner, Ph.D.

    The Policy & Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 7, 2017

Study Start

April 1, 2016

Primary Completion

March 1, 2019

Study Completion

June 1, 2021

Last Updated

November 17, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program sessions were attended). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.

Time Frame
The individual participant dataset will become available twelve months after the study has concluded.

Locations