Pregnancy in AdolescenceNCT03240887
Evaluation of Peer Group Connection
A study testing Peer Group Connection in people with Pregnancy in Adolescence, run by The Policy & Research Group at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pregnancy in Adolescence
- What is being tested?
- Peer Group Connection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,523 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Be intending to enroll in a non-study school in ninth grade.
- Be repeating ninth grade.
- Be unable to complete the questionnaire without assistance.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Policy & Research Group
New Orleans, Louisiana, 70118
About this study
Official title: The Evaluation of Peer Group Connection in Rural North Carolina and New York City, New York
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
Read the detailed description
The Policy \& Research Group (PRG) is conducting a rigorous evaluation of the Peer Group Connection (PGC) program's impact on sexual behaviors associated with teen pregnancy. 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 or 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 (class as usual) groups at a 1:1 ratio. 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.
- Conditions
- Pregnancy in Adolescence
- Being tested
- Peer Group Connection
- Keywords
- Teen pregnancy prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Group ConnectionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)?
Measured: 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?
Measured: 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.
Measured: 1 year after baseline, or the beginning of the 10th grade
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study startApr 2016
- Primary completionMar 2019
- Study completionJun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,523 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Policy & Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS, Mathematica Policy Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Eric Jenner, Ph.D., Principal investigator, The Policy & Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240887
- Sponsor's protocol ID
- 6 TP2AH000037-01-01
- Status last verified
- Nov 2022
- First submitted
- 27 Jul 2017
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Peer Group Connection in Rural North Carolina and New York City, New York
- ClinicalTrials.gov ID
- NCT03240887
- Acronym / sponsor ID
- 6 TP2AH000037-01-01
- Conditions
- Pregnancy in Adolescence
- Keywords
- Teen pregnancy prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,523 participants (actual)
- Lead sponsor
- The Policy & Research GroupUniversity, hospital or other
- Collaborators
- The Office of Adolescent Health, HHS, Mathematica Policy Research, Inc.
- Study start
- Apr 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The Policy \& Research Group (PRG) is conducting a rigorous evaluation of the Peer Group Connection (PGC) program's impact on sexual behaviors associated with teen pregnancy. 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 or 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 (class as usual) groups at a 1:1 ratio. 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer Group Connection (PGC) | Experimental | Behavioral: Peer Group ConnectionNinth-grade participants are assigned to small groups of 10-14 students that attend weekly peer group outreach sessions led by older peer leaders. |
| Business as usual | No intervention | –Ninth grade students remain in their regularly scheduled school classes or activities during PGC outreach times. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Be intending to enroll in a non-study school in ninth grade.
- Be repeating ninth grade.
- Be unable to complete the questionnaire without assistance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer Group ConnectionFaculty 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. | Behavioural | Peer Group Connection (PGC) |
Primary outcome
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)?
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?
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. 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Jenner, Ph.D. principal investigator
The Policy & Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Group Connection in people with Pregnancy in Adolescence, run by The Policy & Research Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual initiation (time frame: 1 year after baseline, or the beginning of the 10th grade). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.