- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06631274
Intervention for Victimized Youth (IVY)
IVY: Intervention for Victimized Youth
Study Overview
Detailed Description
The project involves the development of a virtual intervention program for targets of peer victimization. Intervention for Victimized Youth (IVY) will improve upon many limitations of existing interventions described above since it is the first intervention program to specifically address the needs of targets of peer victimization from a trauma perspective. Moreover, it addresses key limitations of CBITS and increases the flexibility of the intervention by using a virtual delivery model. Just as ivy plants are strong and can flourish in difficult environments, the goal of IVY is for victimized youth to thrive academically and socially despite challenging circumstances. IVY uses a cognitive behavioral therapy (CBT) approach to address current distress due to peer victimization and teach strategies for handling any future peer victimization. Common elements of effective CBT-based trauma treatments are psychoeducation, emotion regulation skills, imaginal or in vivo exposure, cognitive processing, and/or problem solving. Several methods are used within sessions to teach the content, including psychoeducation, didactic teaching, modeling, role playing, and guided self-reflection.
The proposed 8-week intervention. The focus of the first 4 sessions will be on teaching skills to help students overcome emotional difficulties associated with being victimized. Weekly topics include: 1) Introduction & Psychoeducation, 2) Emotional Regulation Skill Building and Practice, 3) Identifying & Coping with Difficult Thoughts and Emotions, and 4) Connecting Thoughts, Emotions, and Behaviors. The last 4 sessions are specific to peer victimization issues with a focus on avoiding re-victimization since victimized youth often are victimized repeatedly and report that they defend other victims. Weekly topics include: 5) Options for Protecting Yourself, 6) Social Problem-Solving Skills, 7) Adaptive Thinking, and 8) Future Planning & Celebration. Participants will be taught several options for intervening. A decision-making process for evaluating social situations will be taught. Based on the outcome of that decision-making process, participants will be taught options for responding with the goal of avoiding re-victimized.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Tallahassee, Florida, United States, 32306
- Florida State University
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Tallahassee, Florida, United States, 32306
- Florida State University Department of Educational Psychology and Learning Systems
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- not current middle school student
- not experience victimization in past month
- no elevated score on BESS
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: 8 weeks of group counseling delivered in virtual environment
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).
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The intervention (IVY; Intervention for Victimized Youth) is an 8 week group counseling intervention delivered in a virtual environment.
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No Intervention: control group
Participants in this arm do not receive the intervention at the same time as the treatment group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Social-emotional Distress
Time Frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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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.
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Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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Change in Knowledge of Self-protection Skills
Time Frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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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.
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Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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Change in Self-efficacy for Protecting Self
Time Frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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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.
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Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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Change in Knowledge of Coping Skills
Time Frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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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.
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Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Peer Victimization
Time Frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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The victim subscale of the Bullying Participant Behavior Questionnaire will be used to assess traditional/in-person victimization.
The scale consists of 10 items Participants respond ranging from 1 (never) to 5 (7 or more times) in the past 30 days.
A mean score was calculated for each participant, which could range from 1 to 5 with higher scores representing more victimization.
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Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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Change in Cyber Victimization
Time Frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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The victim subscale of the Cyber Bullying Participant Rating Scales will be used to assess cyber victimization.
The scale consists of 11 items.
The 6-point Likert scale (1 = not at all to 6 = many times a week) requires participants to rate how often they have been a victim.
A mean score was calculated for each participant, which could range from 1 to 6 with higher scores representing more cyber victimization.
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Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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Change in Traumatic Stress Symptoms
Time Frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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Child PTSD Symptom Screener-Self-Report Version for DSM-5 will be used to assess traumatic stress symptoms.
The scale consists of 16 self-report items with item responses ranging from 0 (not at all) to 4 (6 or more times a week/almost always).
A mean score was calculated for each participant, which could range from 0 to 4 with higher scores representing more traumatic stress.
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Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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Change in Social Support
Time Frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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The Child and Adolescent Social Support Scale will be used to assess perceptions of social support.
Only the peer support scale will be used.
It consists of 12 items with response options ranging from 1 (never) to 6 (always).
A mean score was calculated for each participant, which could range from 1 to 6 with higher scores representing more social support.
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Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004121
- 1R21HD112660 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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