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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD112660 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| control group | No Intervention | Participants in this arm do not receive the intervention at the same time as the treatment group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| counseling | Behavioral | The intervention (IVY; Intervention for Victimized Youth) is an 8 week group counseling intervention delivered in a virtual environment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida State University Department of Educational Psychology and Learning Systems | Tallahassee | Florida | 32306 | United States | ||
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| Label | URL |
|---|---|
| webpage about IVY | View source |
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Pilot program, unable to support requests for IPD
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Parents initially completed an interest survey. Each response was evaluated to assess whether the child met the inclusion criteria and whether the response passed the validity checks to ensure it was not a bot. After passing these checks, a "pre-survey" was sent with a request for the child to complete assent and confirm they experienced at least one instance of bullying in the past month. After returning the second survey, they were randomly assigned to the treatment or control group.
We recruited participants from September 2024 to March 2025. We sent out recruitment information to schools to share with families, conducted targeted online recruitment, posted physical flyers, and used word of mouth snowball recruitment strategies.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | control group | Participants in this arm do not receive the intervention at the same time as the treatment group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). counseling: The intervention (IVY; Intervention for Victimized Youth) is an 8 week group counseling intervention delivered in a virtual environment. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mean item score on a scale | Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit) |
|
Data were collected over a 10 week period, with Time 1 data collected the week before the intervention began and Time 2 data collected during the week week after the intervention ended. The intervention was 8 weekly sessions.
No different from clinicaltrial.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lyndsay Jenkins | Florida State University | (850) 644-4592 | lnjenkins@fsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2024 | Oct 2, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2024 | Oct 2, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2024 | Mar 25, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D058445 | Bullying |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D000374 | Aggression |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000071277 | Harassment, Non-Sexual |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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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.
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| Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit) |
| 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. | 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. | 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. | Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit) |
| Florida State University |
| Tallahassee |
| Florida |
| 32306 |
| United States |
| BG001 | Control Group | Participants in this arm do not receive the intervention at the same time as the treatment group. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | control group | Participants in this arm do not receive the intervention at the same time as the treatment group. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mean item score on a scale | Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit) |
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|
|
|
| Primary | 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. | For this measure, two participants selected the same response option for every item on the scale (e.g., selected "1" for every question, even validity items). We questioned the validity of their responses so we removed those two participants from the analysis for this outcome variable. | Posted | Mean | Standard Deviation | mean item score on a scale | Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit) |
|
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|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mean item score on a scale | Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit) |
|
|
|
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| Secondary | 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. | Posted | Mean | Standard Deviation | mean item score on a scale | Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit) |
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mean item score on a scale | Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit) |
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|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mean item score on a scale | Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit) |
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| Secondary | 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. | Due to an error in the online survey, some participants did not complete the full social support scale, therefore there was missing data on this outcome variable. Participants who did not respond to at least 50% of the items were excluded from analysis. | Posted | Mean | Standard Deviation | mean item score on a scale | Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit) |
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|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | control group | Participants in this arm do not receive the intervention at the same time as the treatment group. | 0 | 20 | 0 | 20 | 0 | 20 |
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| D012919 |
| Social Behavior |
| D005159 | Health Care Facilities Workforce and Services |
| Approach coping at time 1 |
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| Approach coping at time 2 |
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| The outcome measure is approach coping | ANOVA | one-way repeated measures ANOVA was conducted for approach coping | 0.044 | Mean Difference (Final Values) | 0.316 | 2-Sided | 95 | 0.152 | 0.617 | Hedges' g=0.63. The mean difference between the two time points (change) was computed as time2 minus time1. Hedges' g was the standardized mean difference between change in the treatment group and change in the control group. | Equivalence | A one-way repeated measures ANOVA was conducted to examine the impact of intervention, in which participation in the intervention (treatment vs. control) was used as the between-subject factor and time points (time 1 and time 2) was used as the within-subject factor. The interaction between group and time was the focus and was reported. |