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Behavioral Intervention

Counseling for Victimization (IVY Trial)

N/A

Recruiting

Research Sponsored by Florida State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Current middle school student in the US (defined as grades 6, 7, or 8)

Be younger than 18 years old

Must not have

Not a current middle school student

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 1 (baseline); visit 8 (8 weeks after baseline at the termination visit)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to help young people who have been bullied to succeed in school and socially, just like ivy plants thrive in tough conditions.

Who is the study for?

This trial is for middle school students in the US (grades 6-8) who have been bullied at least once in the past month and show high levels of emotional distress according to a specific screening test called BESS.

What is being tested?

The IVY program, which aims to help young victims of bullying thrive academically and socially through counseling, is being tested. The name symbolizes strength and growth despite adversity.

What are the potential side effects?

Since this trial involves counseling rather than medication, there may not be physical side effects. However, discussing sensitive topics might temporarily increase emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a middle school student in grades 6, 7, or 8.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not currently attending middle school.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 1 (baseline); visit 8 (8 weeks after baseline at the termination visit)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 1 (baseline); visit 8 (8 weeks after baseline at the termination visit)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 1 (baseline); visit 8 (8 weeks after baseline at the termination visit) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Knowledge of Self-protection Skills

Change in Self-efficacy for Protecting Self

Change in Social-emotional Distress

+1 more

Secondary study objectives

change in Social Support

change in Traumatic Stress Symptoms

change in cyber victimization

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 8 weeks of group counseling delivered in virtual environmentExperimental Treatment1 Intervention

The treatment to be piloted is a 8 week virtual group counseling intervention with a focus on teaching participants skills to overcome emotional difficulties (Visit 1-4) and avoiding re-victimization (Visit 5-Visit 8).

Group II: control groupActive Control1 Intervention

Participants in this arm do not receive the intervention at the same time as the treatment group.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

counseling

2007

Completed Phase 3

~1580

0 / 2Eligibility criteria met