Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582641
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Evaluation of Peer Group Connection - Middle School
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Peer Group Connection - Middle School PGC-MS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PGC-MS
Brief Summary:
The goal of this randomized trial is to learn if the Peer Group Connection - Middle School PGC-MS intervention delays initiation of sexual intercourse in middle school-aged youth The primary research question it aims to answer is
Sixteen months after being offered the intervention does PGC-MS impact youths initiation of sexual intercourse
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 either 6th or 7th grade Participants randomized to the control group will be offered class-as-usual
Sixteen months after being offered the intervention does PGC-MS impact youths initiation of sexual intercourse
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 either 6th or 7th 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 or 7th grade post-intervention spring semester of 6th or 7th grade four months post-intervention fall semester of 7th or 8th grade and sixteen months post-intervention fall semester of 8th or 9th grade
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None