Teen Pregnancy PreventionPGC-MSNCT06582641
Evaluation of Peer Group Connection - Middle School
A study testing Peer Group Connection - Middle School (PGC-MS) in people with Teen Pregnancy Prevention, run by The Policy & Research Group at 1 site in United States.
Trial summary
This study is a randomized controlled trial to assess the impact of the Peer Group Connection - Middle School (PGC-MS) intervention on pre-sexual behaviors and sexual initiation in middle school-aged youth. The primary research questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- Peer Group Connection - Middle School (PGC-MS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 14 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be enrolled at a middle school participating in the study
- Entering the middle school transition grade for the first time (6th or 7th grade depending on the middle school transition year) at a participating study school
- Provide parental consent and student assent to participate in the study
- Have the ability to complete a self-administered questionnaire in either English or Spanish in a classroom or group setting, unassisted, in 60 minutes or less.
Who cannot join
- Repeating the middle school transition year (6th or 7th grade)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Policy & Research Group
New Orleans, Louisiana, 70118
Hilary Demby, MPH, 504-865-1545, hilary@policyandresearch.com
About this study
Official title: Evaluation of Peer Group Connection - Middle School (PGC-MS)
This study is a randomized controlled trial to assess the impact of the Peer Group Connection - Middle School (PGC-MS) intervention on pre-sexual behaviors and sexual initiation in middle school-aged youth. The primary research questions it aims to answer are:
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reported initiation of sexual intercourse at sixteen months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever smoking a cigarette at four months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever using an electronic vapor product at four months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever having a drink of alcohol at four months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever using marijuana at four months post-intervention?
Read more
Researchers will compare participants randomized to receive PGC-MS (treatment group) to participants randomized to class-as-usual (which contains no sexual or reproductive health information (control group)).
Participants randomized to the treatment group will be offered PGC-MS over the course of their transition year into middle school (6th grade). Participants randomized to the control group will be offered class-as-usual.
Read the detailed description
This is an individual-level, randomized control trial to rigorously evaluate the impact of the Peer Group Connection - Middle School (PGC-MS) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at four time points: baseline (fall semester of 6th grade); post-intervention (spring semester of 6th grade); four months post-intervention (fall semester of 7th grade); and sixteen months post-intervention (fall semester of 8th grade).
- Conditions
- Teen Pregnancy Prevention
- Being tested
- Peer Group Connection - Middle School (PGC-MS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Group Connection - Middle School (PGC-MS)Behavioural
Peer Group Connection - Middle School (PGC-MS) is the treatment condition. PGC-MS is a school-based positive youth development program for students entering the transition year into middle school (6th or 7th grade). PGC-MS aims to improve school engagement and social-emotional learning skills that support adolescent health and educational outcomes for program participants. Participants receive 40-minute outreach sessions held 3 to 4 times per month for the full school year. Schools are expected to implement a minimum of 18 outreach sessions over the school year. PGC-MS outreach sessions are delivered by older peer leaders (8th, 9th, or 10th graders) who are carefully selected by faculty advisors and trained on how to deliver program content.
| Study group | Role | What they receive |
|---|---|---|
| Peer Group Connection - Middle School (PGC-MS) | Experimental | Not described Receives: Behavioral: Peer Group Connection - Middle School (PGC-MS) |
| Class as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initiation of sexual intercourse
Participants are asked the following item: Have you ever had sexual intercourse?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never had sexual intercourse and 1 indicates a person who has had sexual intercourse.
Measured: Assessed 16 months after the intervention period has ended (beginning of the second fall semester following the end of the program)
Ever smoked a cigarette
Description: Participants are asked the following item: Have you ever smoked a cigarette, even one or two puffs?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never smoked a cigarette and 1 indicates a person who has smoked a cigarette.
Measured: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)
Ever used an electronic vapor product
Participants are asked the following item: Have you ever used an electronic vapor product?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never used an electronic vapor product and 1 indicates a person who has used an electronic vapor product.
Measured: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)
Ever had a drink of alcohol
Participants are asked the following item: Have you ever had a drink of alcohol?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never had a drink of alcohol and 1 indicates a person who has had a drink of alcohol.
Measured: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)
Ever used marijuana
Participants are asked the following item: Have you ever used marijuana?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never used marijuana and 1 indicates a person who has used marijuana.
Measured: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Sep 2024
- Primary completionDec 2027 (estimated)
- Study completion14 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen Pregnancy PreventionStudies 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
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Policy & Research Group
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Mathematica Policy Research, Inc., Reproductive Health National Training Center, Center for Supportive Schools
- Responsible party
- Sponsor
- Investigators
- Sarah Walsh, PhD, Principal investigator, The Policy & Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582641
- Sponsor's protocol ID
- 1 TP2AH000083-01-00
- Acronym
- PGC-MS
- Status last verified
- Apr 2026
- First submitted
- 30 Aug 2024
- Last updated
- 18 May 2026
- 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 components were completed). 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 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Peer Group Connection - Middle School (PGC-MS)
- ClinicalTrials.gov ID
- NCT06582641
- Acronym / sponsor ID
- PGC-MS / 1 TP2AH000083-01-00
- Conditions
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- The Policy & Research GroupUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Mathematica Policy Research, Inc., Reproductive Health National Training Center, Center for Supportive Schools
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- 14 Sep 2028 (estimated)
- First posted
- 3 Sep 2024 (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.
This study is a randomized controlled trial to assess the impact of the Peer Group Connection - Middle School (PGC-MS) intervention on pre-sexual behaviors and sexual initiation in middle school-aged youth. The primary research questions it aims to answer are:
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reported initiation of sexual intercourse at sixteen months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever smoking a cigarette at four months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever using an electronic vapor product at four months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever having a drink of alcohol at four months post-intervention?
- What is the impact of the offer to participate in PGC-MS relative to the control group on participants' reports of ever using marijuana at four months post-intervention?
Researchers will compare participants randomized to receive PGC-MS (treatment group) to participants randomized to class-as-usual (which contains no sexual or reproductive health information (control group)).
Participants randomized to the treatment group will be offered PGC-MS over the course of their transition year into middle school (6th grade). Participants randomized to the control group will be offered class-as-usual.
Detailed description
This is an individual-level, randomized control trial to rigorously evaluate the impact of the Peer Group Connection - Middle School (PGC-MS) intervention. Participant outcomes will be assessed using self-reported, individual-level data gathered using a structured questionnaire administered at four time points: baseline (fall semester of 6th grade); post-intervention (spring semester of 6th grade); four months post-intervention (fall semester of 7th grade); and sixteen months post-intervention (fall semester of 8th grade).
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 - Middle School (PGC-MS) | Experimental | Behavioral: Peer Group Connection - Middle School (PGC-MS) |
| Class as usual | No intervention | – |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Be enrolled at a middle school participating in the study
- Entering the middle school transition grade for the first time (6th or 7th grade depending on the middle school transition year) at a participating study school
- Provide parental consent and student assent to participate in the study
- Have the ability to complete a self-administered questionnaire in either English or Spanish in a classroom or group setting, unassisted, in 60 minutes or less.
Key exclusion criteria (1 listed)
- Repeating the middle school transition year (6th or 7th grade)
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 Connection - Middle School (PGC-MS)Peer Group Connection - Middle School (PGC-MS) is the treatment condition. PGC-MS is a school-based positive youth development program for students entering the transition year into middle school (6th or 7th grade). PGC-MS aims to improve school engagement and social-emotional learning skills that support adolescent health and educational outcomes for program participants. Participants receive 40-minute outreach sessions held 3 to 4 times per month for the full school year. Schools are expected to implement a minimum of 18 outreach sessions over the school year. PGC-MS outreach sessions are delivered by older peer leaders (8th, 9th, or 10th graders) who are carefully selected by faculty advisors and trained on how to deliver program content. | Behavioural | Peer Group Connection - Middle School (PGC-MS) |
Primary outcome
Initiation of sexual intercourse
Time frame: Assessed 16 months after the intervention period has ended (beginning of the second fall semester following the end of the program)
Participants are asked the following item: Have you ever had sexual intercourse?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never had sexual intercourse and 1 indicates a person who has had sexual intercourse.
Ever smoked a cigarette
Time frame: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)
Description: Participants are asked the following item: Have you ever smoked a cigarette, even one or two puffs?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never smoked a cigarette and 1 indicates a person who has smoked a cigarette.
Ever used an electronic vapor product
Time frame: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)
Participants are asked the following item: Have you ever used an electronic vapor product?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never used an electronic vapor product and 1 indicates a person who has used an electronic vapor product.
Ever had a drink of alcohol
Time frame: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)
Participants are asked the following item: Have you ever had a drink of alcohol?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never had a drink of alcohol and 1 indicates a person who has had a drink of alcohol.
Ever used marijuana
Time frame: Assessed 4 months after the intervention period has ended (beginning of the first fall semester following the end of the program)
Participants are asked the following item: Have you ever used marijuana?. The resulting variable is dichotomous with values 0 or 1, where 0 indicates a person who has never used marijuana and 1 indicates a person who has used marijuana.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- 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 components were completed). 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.
Sarah Walsh, PhD 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 - Middle School (PGC-MS) in people with Teen Pregnancy Prevention, 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 1 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: looking for participants now, as of the sponsor's last update on 18 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hilary Demby, MPH (504-655-0982, hilary@policyandresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initiation of sexual intercourse (time frame: Assessed 16 months after the intervention period has ended (beginning of the second fall semester following the end of the program)). The study lists 5 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 18 May 2026.