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Intervention for Victimized Youth

IVY: Intervention for Victimized Youth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06631274
Acronym
IVY
Enrollment
48
Registered
2024-10-08
Start date
2024-10-21
Completion date
2025-03-10
Last updated
2025-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Victimization

Keywords

peer victimization, bullying, trauma

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.

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.

Interventions

BEHAVIORALcounseling

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

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Florida State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
11 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Social-emotional DistressVisit 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 SkillsVisit 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 SelfVisit 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 SkillsVisit 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.

Secondary

MeasureTime frameDescription
Change in Peer VictimizationVisit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)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.
Change in Cyber VictimizationVisit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)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.
Change in Traumatic Stress SymptomsVisit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)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.
Change in Social SupportVisit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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.
22
Control Group
Participants in this arm do not receive the intervention at the same time as the treatment group.
20
Total42

Baseline characteristics

CharacteristicControl GroupTotal8 Weeks of Group Counseling Delivered in Virtual Environment
Age, Categorical
<=18 years
20 Participants42 Participants22 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants7 Participants7 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants35 Participants15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Black or African American
8 Participants14 Participants6 Participants
Race (NIH/OMB)
More than one race
2 Participants2 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
8 Participants24 Participants16 Participants
Region of Enrollment
United States
20 participants42 participants22 participants
Sex: Female, Male
Female
12 Participants17 Participants5 Participants
Sex: Female, Male
Male
8 Participants25 Participants17 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 220 / 20
other
Total, other adverse events
0 / 220 / 20
serious
Total, serious adverse events
0 / 220 / 20

Outcome results

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
8 weeks of group counseling delivered in virtual environmentChange in Knowledge of Coping SkillsAvoidance coping at time 12.00 mean item score on a scaleStandard Deviation 0.46
8 weeks of group counseling delivered in virtual environmentChange in Knowledge of Coping SkillsAvoidance coping at time 22.18 mean item score on a scaleStandard Deviation 0.41
8 weeks of group counseling delivered in virtual environmentChange in Knowledge of Coping SkillsApproach coping at time 12.44 mean item score on a scaleStandard Deviation 0.56
8 weeks of group counseling delivered in virtual environmentChange in Knowledge of Coping SkillsApproach coping at time 22.42 mean item score on a scaleStandard Deviation 0.58
control groupChange in Knowledge of Coping SkillsApproach coping at time 22.86 mean item score on a scaleStandard Deviation 0.65
control groupChange in Knowledge of Coping SkillsAvoidance coping at time 12.17 mean item score on a scaleStandard Deviation 0.45
control groupChange in Knowledge of Coping SkillsApproach coping at time 12.56 mean item score on a scaleStandard Deviation 0.59
control groupChange in Knowledge of Coping SkillsAvoidance coping at time 22.08 mean item score on a scaleStandard Deviation 0.52
Comparison: The outcome measure is avoidance copingp-value: 0.59995% CI: [-0.212, 0.367]ANOVA
Comparison: The outcome measure is approach copingp-value: 0.04495% CI: [0.152, 0.617]ANOVA
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
8 weeks of group counseling delivered in virtual environmentChange in Knowledge of Self-protection SkillsKnowledge of Self-Protection Options at Time 11.18 mean item score on a scaleStandard Deviation 0.39
8 weeks of group counseling delivered in virtual environmentChange in Knowledge of Self-protection SkillsKnowledge of Self-Protection Options at Time 21.59 mean item score on a scaleStandard Deviation 0.4
control groupChange in Knowledge of Self-protection SkillsKnowledge of Self-Protection Options at Time 11.16 mean item score on a scaleStandard Deviation 0.41
control groupChange in Knowledge of Self-protection SkillsKnowledge of Self-Protection Options at Time 21.24 mean item score on a scaleStandard Deviation 0.37
p-value: <0.0195% CI: [0.112, 0.539]ANOVA
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.

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
8 weeks of group counseling delivered in virtual environmentChange in Self-efficacy for Protecting SelfSelf-Efficacy for Protecting Self at Time 14.52 mean item score on a scaleStandard Deviation 1.27
8 weeks of group counseling delivered in virtual environmentChange in Self-efficacy for Protecting SelfSelf-Efficacy for Protecting Self at Time 24.19 mean item score on a scaleStandard Deviation 1.26
control groupChange in Self-efficacy for Protecting SelfSelf-Efficacy for Protecting Self at Time 14.14 mean item score on a scaleStandard Deviation 1.23
control groupChange in Self-efficacy for Protecting SelfSelf-Efficacy for Protecting Self at Time 25.19 mean item score on a scaleStandard Deviation 1.62
p-value: 0.1195% CI: [-0.187, 1.549]ANOVA
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
8 weeks of group counseling delivered in virtual environmentChange in Social-emotional DistressPersonal adjustment at time 20.97 mean item score on a scaleStandard Deviation 0.61
8 weeks of group counseling delivered in virtual environmentChange in Social-emotional DistressInternalizing Problems at time 21.28 mean item score on a scaleStandard Deviation 0.55
8 weeks of group counseling delivered in virtual environmentChange in Social-emotional DistressInternalizing Problems at time 11.16 mean item score on a scaleStandard Deviation 0.67
8 weeks of group counseling delivered in virtual environmentChange in Social-emotional DistressPersonal adjustment at time 11.09 mean item score on a scaleStandard Deviation 0.53
control groupChange in Social-emotional DistressInternalizing Problems at time 11.31 mean item score on a scaleStandard Deviation 0.56
control groupChange in Social-emotional DistressPersonal adjustment at time 21.00 mean item score on a scaleStandard Deviation 0.61
control groupChange in Social-emotional DistressPersonal adjustment at time 11.07 mean item score on a scaleStandard Deviation 0.55
control groupChange in Social-emotional DistressInternalizing Problems at time 21.24 mean item score on a scaleStandard Deviation 0.61
Comparison: The outcome measure is personal adjustmentp-value: 0.64695% CI: [-0.296, 0.184]ANOVA
Comparison: The outcome measure is internalizing problemsp-value: 0.19695% CI: [-0.096, 0.473]ANOVA
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
8 weeks of group counseling delivered in virtual environmentChange in Cyber VictimizationCyber victimization at time 11.47 mean item score on a scaleStandard Deviation 0.68
8 weeks of group counseling delivered in virtual environmentChange in Cyber VictimizationCyber victimization at time 22.18 mean item score on a scaleStandard Deviation 1.06
control groupChange in Cyber VictimizationCyber victimization at time 11.39 mean item score on a scaleStandard Deviation 0.66
control groupChange in Cyber VictimizationCyber victimization at time 21.67 mean item score on a scaleStandard Deviation 0.82
p-value: 0.049895% CI: [-1.178, -0.0005]ANOVA
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
8 weeks of group counseling delivered in virtual environmentChange in Peer VictimizationPeer victimization at time 12.60 mean item score on a scaleStandard Deviation 1.22
8 weeks of group counseling delivered in virtual environmentChange in Peer VictimizationPeer victimization at time 22.55 mean item score on a scaleStandard Deviation 1.11
control groupChange in Peer VictimizationPeer victimization at time 12.69 mean item score on a scaleStandard Deviation 1.1
control groupChange in Peer VictimizationPeer victimization at time 21.63 mean item score on a scaleStandard Deviation 0.83
p-value: <0.0195% CI: [0.284, 1.764]ANOVA
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.

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
8 weeks of group counseling delivered in virtual environmentChange in Social SupportPeer support at time 24.02 mean item score on a scaleStandard Deviation 0.89
8 weeks of group counseling delivered in virtual environmentChange in Social SupportPeer support at time 13.96 mean item score on a scaleStandard Deviation 1.1
control groupChange in Social SupportPeer support at time 24.15 mean item score on a scaleStandard Deviation 1.2
control groupChange in Social SupportPeer support at time 14.05 mean item score on a scaleStandard Deviation 1.15
p-value: 0.92795% CI: [-0.612, 0.551]ANOVA
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.

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

ArmMeasureGroupValue (MEAN)Dispersion
8 weeks of group counseling delivered in virtual environmentChange in Traumatic Stress SymptomsTraumatic stress at time 12.11 mean item score on a scaleStandard Deviation 0.68
8 weeks of group counseling delivered in virtual environmentChange in Traumatic Stress SymptomsTraumatic stress at time 22.15 mean item score on a scaleStandard Deviation 0.73
control groupChange in Traumatic Stress SymptomsTraumatic stress at time 12.31 mean item score on a scaleStandard Deviation 0.74
control groupChange in Traumatic Stress SymptomsTraumatic stress at time 22.22 mean item score on a scaleStandard Deviation 0.56
p-value: 0.18295% CI: [-0.127, 0.65]ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026