VictimizationIVYNCT06631274
Intervention for Victimized Youth
A study testing counseling in people with Victimization, run by Florida State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 14 years
- Conditions the study is for
- Victimization
- What is being tested?
- counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Oct 2024to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- not current middle school student
- not experience victimization in past month
- no elevated score on BESS
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Florida State University Department of Educational Psychology and Learning Systems
Tallahassee, Florida, 32306
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: IVY: Intervention for Victimized Youth
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.
Read the 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.
- Conditions
- Victimization
- Being tested
- counseling
- Keywords
- peer victimization, bullying, trauma
- Medical subject headings
- Bullying, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counselingBehavioural
The intervention (IVY; Intervention for Victimized Youth) is an 8 week group counseling intervention delivered in a virtual environment.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: counseling |
| control group | No intervention | Participants in this arm do not receive the intervention at the same time as the treatment group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
Secondary outcomes (4)
Change in Peer Victimization
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.
Measured: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
Change in Cyber Victimization
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.
Measured: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
Change in Traumatic Stress Symptoms
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.
Measured: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
Change in Social Support
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.
Measured: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start21 Oct 2024
- Primary completion10 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for VictimizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Lyndsay Jenkins, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631274
- Sponsor's protocol ID
- STUDY00004121
- Other IDs
- 1R21HD112660
- Acronym
- IVY
- Status last verified
- Nov 2025
- First submitted
- 4 Oct 2024
- Last updated
- 25 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot program, unable to support requests for IPD
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IVY: Intervention for Victimized Youth
- ClinicalTrials.gov ID
- NCT06631274
- Acronym / sponsor ID
- IVY / STUDY00004121
- Conditions
- Victimization
- Keywords
- peer victimization, bullying, trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Posted 25 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 8 weeks of group counseling delivered in virtual environment | Other | Behavioral: counselingThe 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). |
| control group | No intervention | –Participants in this arm do not receive the intervention at the same time as the treatment group. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- not current middle school student
- not experience victimization in past month
- no elevated score on BESS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| counselingThe intervention (IVY; Intervention for Victimized Youth) is an 8 week group counseling intervention delivered in a virtual environment. | Behavioural | 8 weeks of group counseling delivered in virtual environment |
Primary outcome
Change in Social-emotional Distress
Time frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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.
Change in Knowledge of Self-protection Skills
Time frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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.
Change in Self-efficacy for Protecting Self
Time frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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.
Change in Knowledge of Coping Skills
Time frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
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.
4 secondary outcomes
Change in Peer Victimization
Time frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
Change in Cyber Victimization
Time frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
Change in Traumatic Stress Symptoms
Time frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
Change in Social Support
Time frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- webpage about IVYLink provided by the sponsor.
- Individual participant dataSharing planned: No. Pilot program, unable to support requests for IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling in people with Victimization, run by Florida State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Social-emotional Distress (time frame: Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.