NIH R01 Friend to Friend With Coaching (NCT04164472) | Clinical Trial Compass
CompletedNot Applicable
NIH R01 Friend to Friend With Coaching
United States5,250 participantsStarted 2019-11-12
Plain-language summary
This study examines the effectiveness of the Friend to Friend (F2F) program when conducted by teachers and counselors with active coaching from the research team. The project involves 14 small group sessions for relationally aggressive girls and 8 classroom sessions. Students, teachers, counselors and parents at intervention and control schools fill out pre- and post- program questionnaires.
Who can participate
Age range
7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. Urban school from the School District of Philadelphia
. Predominately minority student body (\> 80%)
. Relatively large school with at least 2 classrooms per grade
. School is not currently involved in a systematic anti-aggression or bullying prevention program
. School must have at least 1 school counselor who is interested in participating
. All boys and girls in regular education 4th-5th grade classrooms will be eligible to participate in screening and outcome assessment activities.
. Screening will include a peer-rating procedure that will be utilized to identify girls with relational aggression (GRAs).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in hostile attribution biases
Timeframe: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later
2
Change in Knowledge of Anger Problem-Solving Steps
Timeframe: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later
3
Change in Relational Aggression
Timeframe: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later
4
Change in Prosocial Leadership
Timeframe: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later
5
Change in Teacher-Student Relationships
Timeframe: Given two times throughout the study, first at baseline (early in the school year, October/November) and up to 8 months later
6
Change in Staff Self-Efficacy for Handling Aggression
Timeframe: Given two times throughout the study, first at baseline (early in the school year, October/November) and on up to 8 months later
. GRAs will be based on if they score \> .50 of a Standard Deviation above mean on relational aggression on the peer-rating measure. These identified girls will be recruited (with written parent consent and student assent) to participate in the F2F with Coaching or control condition.