Trial Outcomes & Findings for Intervention for Victimized Youth (NCT NCT06631274)
NCT ID: NCT06631274
Last Updated: 2025-11-25
Results Overview
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.
COMPLETED
NA
48 participants
Visit 1 (baseline); Visit 8 (8 weeks after baseline at the termination visit)
2025-11-25
Participant Flow
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.
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.
Participant milestones
| Measure |
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).
|
control group
Participants in this arm do not receive the intervention at the same time as the treatment group.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
25
|
|
Overall Study
COMPLETED
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intervention for Victimized Youth
Baseline characteristics by cohort
| Measure |
8 Weeks of Group Counseling Delivered in Virtual Environment
n=22 Participants
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.
|
Control Group
n=20 Participants
Participants in this arm do not receive the intervention at the same time as the treatment group.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=45 Participants
|
20 Participants
n=12929 Participants
|
42 Participants
n=6349 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=45 Participants
|
12 Participants
n=12929 Participants
|
17 Participants
n=6349 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=45 Participants
|
8 Participants
n=12929 Participants
|
25 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
7 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=45 Participants
|
20 Participants
n=12929 Participants
|
35 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=45 Participants
|
8 Participants
n=12929 Participants
|
14 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=45 Participants
|
8 Participants
n=12929 Participants
|
24 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=45 Participants
|
2 Participants
n=12929 Participants
|
2 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=45 Participants
|
20 participants
n=12929 Participants
|
42 participants
n=6349 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
8 weeks of group counseling delivered in virtual environment
n=22 Participants
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
n=20 Participants
Participants in this arm do not receive the intervention at the same time as the treatment group.
|
|---|---|---|
|
Change in Social-emotional Distress
Personal adjustment at time 1
|
1.09 mean item score on a scale
Standard Deviation 0.53
|
1.07 mean item score on a scale
Standard Deviation 0.55
|
|
Change in Social-emotional Distress
Personal adjustment at time 2
|
0.97 mean item score on a scale
Standard Deviation 0.61
|
1.00 mean item score on a scale
Standard Deviation 0.61
|
|
Change in Social-emotional Distress
Internalizing Problems at time 1
|
1.16 mean item score on a scale
Standard Deviation 0.67
|
1.31 mean item score on a scale
Standard Deviation 0.56
|
|
Change in Social-emotional Distress
Internalizing Problems at time 2
|
1.28 mean item score on a scale
Standard Deviation 0.55
|
1.24 mean item score on a scale
Standard Deviation 0.61
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
8 weeks of group counseling delivered in virtual environment
n=22 Participants
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
n=20 Participants
Participants in this arm do not receive the intervention at the same time as the treatment group.
|
|---|---|---|
|
Change in Knowledge of Self-protection Skills
Knowledge of Self-Protection Options at Time 2
|
1.59 mean item score on a scale
Standard Deviation 0.40
|
1.24 mean item score on a scale
Standard Deviation 0.37
|
|
Change in Knowledge of Self-protection Skills
Knowledge of Self-Protection Options at Time 1
|
1.18 mean item score on a scale
Standard Deviation 0.39
|
1.16 mean item score on a scale
Standard Deviation 0.41
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
8 weeks of group counseling delivered in virtual environment
n=20 Participants
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
n=20 Participants
Participants in this arm do not receive the intervention at the same time as the treatment group.
|
|---|---|---|
|
Change in Self-efficacy for Protecting Self
Self-Efficacy for Protecting Self at Time 1
|
4.52 mean item score on a scale
Standard Deviation 1.27
|
4.14 mean item score on a scale
Standard Deviation 1.23
|
|
Change in Self-efficacy for Protecting Self
Self-Efficacy for Protecting Self at Time 2
|
4.19 mean item score on a scale
Standard Deviation 1.26
|
5.19 mean item score on a scale
Standard Deviation 1.62
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
8 weeks of group counseling delivered in virtual environment
n=22 Participants
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
n=20 Participants
Participants in this arm do not receive the intervention at the same time as the treatment group.
|
|---|---|---|
|
Change in Knowledge of Coping Skills
Avoidance coping at time 1
|
2.00 mean item score on a scale
Standard Deviation 0.46
|
2.17 mean item score on a scale
Standard Deviation 0.45
|
|
Change in Knowledge of Coping Skills
Avoidance coping at time 2
|
2.18 mean item score on a scale
Standard Deviation 0.41
|
2.08 mean item score on a scale
Standard Deviation 0.52
|
|
Change in Knowledge of Coping Skills
Approach coping at time 1
|
2.44 mean item score on a scale
Standard Deviation 0.56
|
2.56 mean item score on a scale
Standard Deviation 0.59
|
|
Change in Knowledge of Coping Skills
Approach coping at time 2
|
2.42 mean item score on a scale
Standard Deviation 0.58
|
2.86 mean item score on a scale
Standard Deviation 0.65
|
SECONDARY outcome
Timeframe: Visit 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.
Outcome measures
| Measure |
8 weeks of group counseling delivered in virtual environment
n=22 Participants
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
n=20 Participants
Participants in this arm do not receive the intervention at the same time as the treatment group.
|
|---|---|---|
|
Change in Peer Victimization
Peer victimization at time 1
|
2.60 mean item score on a scale
Standard Deviation 1.22
|
2.69 mean item score on a scale
Standard Deviation 1.10
|
|
Change in Peer Victimization
Peer victimization at time 2
|
2.55 mean item score on a scale
Standard Deviation 1.11
|
1.63 mean item score on a scale
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Visit 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.
Outcome measures
| Measure |
8 weeks of group counseling delivered in virtual environment
n=22 Participants
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
n=20 Participants
Participants in this arm do not receive the intervention at the same time as the treatment group.
|
|---|---|---|
|
Change in Cyber Victimization
Cyber victimization at time 1
|
1.47 mean item score on a scale
Standard Deviation 0.68
|
1.39 mean item score on a scale
Standard Deviation 0.66
|
|
Change in Cyber Victimization
Cyber victimization at time 2
|
2.18 mean item score on a scale
Standard Deviation 1.06
|
1.67 mean item score on a scale
Standard Deviation 0.82
|
SECONDARY outcome
Timeframe: Visit 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.
Outcome measures
| Measure |
8 weeks of group counseling delivered in virtual environment
n=22 Participants
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
n=20 Participants
Participants in this arm do not receive the intervention at the same time as the treatment group.
|
|---|---|---|
|
Change in Traumatic Stress Symptoms
Traumatic stress at time 1
|
2.11 mean item score on a scale
Standard Deviation 0.68
|
2.31 mean item score on a scale
Standard Deviation 0.74
|
|
Change in Traumatic Stress Symptoms
Traumatic stress at time 2
|
2.15 mean item score on a scale
Standard Deviation 0.73
|
2.22 mean item score on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
8 weeks of group counseling delivered in virtual environment
n=14 Participants
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
n=9 Participants
Participants in this arm do not receive the intervention at the same time as the treatment group.
|
|---|---|---|
|
Change in Social Support
Peer support at time 1
|
3.96 mean item score on a scale
Standard Deviation 1.10
|
4.05 mean item score on a scale
Standard Deviation 1.15
|
|
Change in Social Support
Peer support at time 2
|
4.02 mean item score on a scale
Standard Deviation 0.89
|
4.15 mean item score on a scale
Standard Deviation 1.20
|
Adverse Events
8 weeks of group counseling delivered in virtual environment
control group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place