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Trial record 3 of 15 for:    Recruiting, Not yet recruiting, Available Studies | "Pregnancy in Adolescence"

Evaluation of Peer Group Connection

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ClinicalTrials.gov Identifier: NCT03240887
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : August 7, 2017
Sponsor:
Collaborators:
The Office of Adolescent Health, HHS
Mathematica Policy Research, Inc.
Information provided by (Responsible Party):
The Policy & Research Group

Brief Summary:
A randomized control trial will be conducted in high schools in North Carolina and New York City to determine the impact of a school-based, positive youth development program on both sexual behaviors associated with teen pregnancy and education outcomes.

Condition or disease Intervention/treatment Phase
Pregnancy in Adolescence Behavioral: Peer Group Connection Not Applicable

Detailed Description:

The Policy & Research Group (PRG) will conduct a rigorous evaluation of the Peer Group Connection program's impact on sexual behaviors associated with teen pregnancy, as well as education outcomes. Peer Group Connection (PGC) is a school-based, group peer mentoring program for ninth grade students that is designed to facilitate the transition into high school and improve non-cognitive abilities, student engagement, and educational outcomes. The study enrolls students from high schools that serve large populations of economically disadvantaged and minority students in communities with high teenage birth rates. In North Carolina, the study is being implemented in schools serving rural populations, and in New York City, schools serving largely Hispanic and other minority populations are targeted.

As part of the PGC program, ninth-grade participants attend weekly group outreach sessions led by older peer leaders. Outreach sessions occur during regularly scheduled classes (participants are pulled from their classes to attend). They include hands-on activities, simulations, and discussions intended to build group cohesion and to improve the decision-making skills of group members. A minimum of 18, 45-minute outreach sessions are expected to be offered to PGC participants during the course of their ninth-grade year. Although PGC is not explicitly a sexual health/teen pregnancy prevention program, the belief is that by engaging ninth grade students in school, building connectedness among peers, and building students' decision-making and goal-setting skills, PGC will encourage students to make healthier decisions, including reducing sexual risk-taking and increasing protective behaviors.

The comparison condition consists of normally scheduled classes or activities (e.g., Physical Education/Health class, elective class, or homeroom period) that comparison group participants are assigned to during the period that PGC outreaches occur. Comparison group participants will therefore receive more time in the regularly scheduled class than will the treatment group, but there will be no alternative program or additional activities offered to the participants assigned to the comparison group.

The study is an individual randomized controlled trial in which eligible, consenting ninth grade participants are randomly assigned by the evaluator to intervention (PGC) or control (business as usual) groups at a 1:1 ratio. Primary outcomes will be assessed using questionnaire data gathered at three time points: baseline, occurring during the fall of participants' 9th grade year (prior to the provision of any PGC programming), and follow-up during the fall of their 10th and 11th grade years. Primary outcomes of interest include sexual initiation, frequency of any type of sex, and number of sexual partners.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Evaluation of Peer Group Connection in Rural North Carolina and New York City, New York
Actual Study Start Date : April 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Peer Group Connection (PGC)
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
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.

No Intervention: Business as usual
Ninth grade students remain in their regularly scheduled school classes or activities during PGC outreach times.



Primary Outcome Measures :
  1. Sexual initiation [ Time Frame: 1 year after baseline, or the beginning of the 10th grade ]
    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)?

  2. Frequency of sex [ Time Frame: 1 year after baseline, or the beginning of the 10th grade ]
    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?

  3. Number of sexual partners [ Time Frame: 1 year after baseline, or the beginning of the 10th grade ]
    The outcome is operationalized as the count of the number of sexual partners a participant reports having in the past 3 months. One questionnaire item measures number of sexual partners: How many sexual partners have you had in the past 3 months?



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be enrolled at a study school
  2. Provide parental consent and personal assent to participate in the study
  3. 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.)
  4. Be entering the ninth grade for the first time.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240887


Contacts
Contact: Lynne W Jenner, MA 504-865-1545 ljenner@policyandresearch.com
Contact: Kelly Burgess, MPH 225-773-9162 kelly@policyandresearch.com

Locations
United States, Louisiana
The Policy & Research Group Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Lynne Jenner, MA    504-865-1545    ljenner@policyandresearch.com   
Sponsors and Collaborators
The Policy & Research Group
The Office of Adolescent Health, HHS
Mathematica Policy Research, Inc.
Investigators
Principal Investigator: Eric Jenner, Ph.D. The Policy & Research Group

Responsible Party: The Policy & Research Group
ClinicalTrials.gov Identifier: NCT03240887     History of Changes
Other Study ID Numbers: 6 TP2AH000037-01-01
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by The Policy & Research Group:
Teen pregnancy prevention