NCT06631274

Brief Summary

IVY (Intervention for Victimized Youth). Just as ivy plants are strong and can flourish in difficult environments, the goal of IVY will be for targets of peer victimization to thrive academically and socially despite challenging circumstances.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
9 months until next milestone

Results Posted

Study results publicly available

November 25, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

October 4, 2024

Results QC Date

October 6, 2025

Last Update Submit

November 12, 2025

Conditions

Keywords

peer victimizationbullyingtrauma

Outcome Measures

Primary Outcomes (4)

  • Change in Social-emotional Distress

    The Behavioral and Emotional Screening System is a 30 item measure. For each item, participants decide how often a statement is true for them and respond using a 4-point Likert scale (0=never to 3=always). Personal adjustment is measured by 8 items (possible mean scores ranging from 0 to 3) and internalizing problems is measured by 10 items (possible mean scores ranging from 0 to 3). Mean item scores are computed for personal adjustment and internalizing problems, respectively, at pretest (time 1) and posttest (time 2). For both subscales, higher scores indicate greater difficulties, i.e., worse adjustment and worse internalizing issues.

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

  • Change in Knowledge of Self-protection Skills

    The Knowledge of Self-Protection Options (KSPO) scale consists of 9 items assessing the degree to which participants have knowledge of how to protect themselves. Participants are asked "If I am being bullied, I know how to..." then rate each item on a 3 point scale ranging from 0 (No), 1 (A little bit), or 2 (Yes). Mean scores were calculated for each participant, which could range from 0 to 2, which higher scores representing greater knowledge of how to protect oneself.

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

  • Change in Self-efficacy for Protecting Self

    The Self-Efficacy for Protecting Self (SEPS) scale consists of 8 items with the stem of "How do you rate your ability to engage in each action?" Response options range from 1 (I can not do this well at all) to 4 (I can do this very well). Mean scores were calculated for each participant, which could range from 1 to 4, which higher scores representing greater efficacy in protecting oneself.

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

  • Change in Knowledge of Coping Skills

    Coping skills will be measured using the Brief COPE, which is a 28-item scale that assesses coping strategies. Items are rated on a scale from 1 (I haven't been doing this at all) to 4 (I've been doing this a lot). Avoidance coping is measured by 11 items and approach coping is measured by 12 items. Mean scores were calculated for each participant, which could range from 1 to 4, which higher scores representing greater knowledge of how to protect oneself.

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

Secondary Outcomes (4)

  • Change in Peer Victimization

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

  • Change in Cyber Victimization

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

  • Change in Traumatic Stress Symptoms

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

  • Change in Social Support

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

Study Arms (2)

8 weeks of group counseling delivered in virtual environment

OTHER

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).

Behavioral: counseling

control group

NO INTERVENTION

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

Interventions

counselingBEHAVIORAL

The intervention (IVY; Intervention for Victimized Youth) is an 8 week group counseling intervention delivered in a virtual environment.

8 weeks of group counseling delivered in virtual environment

Eligibility Criteria

Age11 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • current middle school student in US (defined as grades 6, 7, or 8)
  • experience at least one instance of peer victimization in past month
  • Have elevated or extremely elevated social-emotional distress score, as measured by the BESS (Behavior and Emotional Screening System)

You may not qualify if:

  • not current middle school student
  • not experience victimization in past month
  • no elevated score on BESS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida State University Department of Educational Psychology and Learning Systems

Tallahassee, Florida, 32306, United States

Location

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Links

MeSH Terms

Conditions

BullyingWounds and Injuries

Interventions

Counseling

Condition Hierarchy (Ancestors)

AggressionBehavioral SymptomsBehaviorHarassment, Non-SexualSocial Behavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Lyndsay Jenkins
Organization
Florida State University

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: We are using a waitlist control model where half of the participants will be randomly assigned to the treatment condition. When that intervention is completed, the treatment will be offered to the waitlist participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2024

First Posted

October 8, 2024

Study Start

October 21, 2024

Primary Completion

March 10, 2025

Study Completion

March 10, 2025

Last Updated

November 25, 2025

Results First Posted

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Pilot program, unable to support requests for IPD

Locations