About this trial
The goal of this clinical trial is to see if a specific intervention program that uses virtual reality (VR) helps young people reduce aggressive behavior more than the same program without VR or their usual treatment. The study will also look at how the program affects anger, impulsivity, emotional control, and how participants understand and handle conflicts with others.
The main questions the study wants to answer are:
* Does the intervention program with VR help young people reduce aggressive behavior more than the same program without VR or just their usual treatment? * What changes in the mind and body are linked to improvements in aggressive behavior and emotional control?
The researchers will compare three groups of young people:
* Usual treatment plus the 4-session intervention program with VR. * Usual treatment plus the 4-session intervention program without VR. * Usual treatment only.
Participants will:
* Attend 4 individual sessions lasting 1 to 1.5 hours, once a week. * Take part in activities to learn how to recognize emotions, understand conflict situations, and manage anger and impulsivity. * Complete questionnaires about aggressive behavior, anger, impulsivity, emotional control, and how they interpret conflicts. * Have their aggressive behavior recorded through disciplinary reports at the center. * Provide saliva samples before and after sessions to measure hormones related to stress and aggression. * Wear a chest band that measures heart rate and a headset that records brain activity during the VR activities.
All data will be kept confidential, and the identities of participants will be protected at all times.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
12-18 years old at the moment of recruitment and allocation.
Minimum facility stay of 6 months since the begining of the study.
Documented records of recent aggresive behavior.
Disqualifiers
Neurological disorder, brain injury, or psyquiatric pathology that affects cognitive functions or advises against use of virtual reality.
Not being fluent in Spanish.
Trial design
Parallel
Treatments tested in this trial
Virtual Reality
BehavioralThis group will receive 4 individual behavioral therapy sessions on emotion recognition, hostile attribution bias, anger management, and social problem-solving. During these sessions, participants will train specific abilities through various activities. The activities are designed as a serious game in a virtual reality setting and include: emotion identification and recognition, practicing interpreting frustrating situations without assuming hostility, anger regulation in provocative situations, and decision-making in interpersonal conflict situations. In addition, there will be one session before the program to collect baseline data and one session after the program to collect post-intervention data. A follow-up session will take place 3 months after the post-intervention assessment.
Active Control
BehavioralThis group will receive the same intervention as the Virtual Reality group, but in a group format (4 participants per group). The training and activities will be conducted using video or paper materials and traditional psychological techniques such as imagination. There will be 4 group behavioral therapy sessions on emotion recognition, hostile attribution bias, anger management, and social problem-solving. During these sessions, participants will train specific abilities through various activities. The activities include: emotion identification and recognition, practicing interpreting frustrating situations without assuming hostility, anger regulation in provocative situations, and decision-making in interpersonal conflict situations. In addition, there will be one session before the program to collect baseline data and one session after the program to collect post-intervention data. A follow-up session will take place 3 months after the post-intervention assessment.
Treatment as usual
BehavioralParticipants in this group will receive treatment as usual provided by the facility, with no additional intervention. Treatment will be delivered over the same period of time as in the other study groups. Participants will complete one baseline assessment before the study period, one post-intervention assessment, and a follow-up assessment 3 months after the post-intervention evaluation.
Treatment groups
Trial outcomes
Primary outcomes
Overall aggression measured with the Aggression Questionnaire (AQ)
The Aggression Questionnaire (AQ) is a 29-item self-report instrument assessing aggression. Each item is rated on a 5-point Likert scale (1-5). Total scores range from 29 to 145, with higher scores indicating higher levels of aggression. The questionnaire includes four subscales: physical aggression, verbal aggression, anger, and hostility.
Proactive aggression measured with the Reactive-Proactive Questionnaire (RPQ)
The proactive aggression subscale consists of 12 items rated on a 3-point scale (0-2), with scores ranging from 0 to 24. Higher scores indicate higher levels of proactive aggression.
Reactive aggression measured with the Reactive-Proactive Aggression Questionnaire (RPQ)
The reactive aggression subscale consists of 11 items rated on a 3-point scale (0-2), with scores ranging from 0 to 22. Higher scores indicate higher levels of reactive aggression.
Observed aggressive behavior recorded through disciplinary incidents in residential centers
Aggressive behavior will be assessed using institutional disciplinary records documented by educators in the residential centers where participants reside. The outcome will be calculated as the mean number of disciplinary incidents involving aggressive behavior per week. Incidents are recorded as part of the routine disciplinary procedures of the centers. The average weekly number of incidents will be examined across three time periods: three months before the intervention (baseline), during the intervention, and three months after the intervention.
Secondary outcomes
Trait anger measured with the State-Trait Anger Expression Inventory-2 (STAXI-2)
The Trait Anger subscale of the STAXI-2 is a self-report questionnaire consisting of 10 items rated on a 4-point Likert scale (1-4). Total scores range from 10 to 40, with higher scores indicating higher levels of trait anger.
Anger expression and control measured with the State-Trait Anger Expression Inventory-2 (STAXI-2)
The Anger Expression/Control Index of the STAXI-2 is derived from 24 items: 6 items from the Anger Expression-Out subscale, 6 items from the Anger Expression-In subscale, 6 items from the Anger Control-Out subscale, and 6 items from the Anger Control-In subscale. Each item is rated on a 4-point Likert scale (1-4). Higher scores indicate that the individual experiences intense feelings of anger, which may be suppressed or expressed through aggressive behaviors. This is a self-report questionnaire completed by the participants.
State anger measured with the State-Trait Anger Expression Inventory-2 (STAXI-2)
The State Anger subscale of the STAXI-2 is a self-report questionnaire consisting of 15 items rated on a 4-point Likert scale (1-4). Total scores range from 15 to 60, with higher scores indicating higher levels of state anger. To assess state anger, participants are asked to recall and imagine a personal situation that previously elicited anger. The same recalled situation is used at all assessment points to standardize the elicitation of anger before completing the questionnaire.
Hostile attribution bias measured with the Social Information Processing-Attribution and Emotional Response Questionnaire (SIP-AEQ)
The Social Information Processing-Attribution and Emotional Response Questionnaire (SIP-AEQ) is a self-report instrument designed to assess attributional and emotional responses to ambiguous aversive social situations. The questionnaire includes 8 short vignettes describing ambiguous interpersonal scenarios. Each vignette is followed by 6 items rated on a 4-point Likert scale (0 = not at all likely to 3 = very likely). The Hostile Attribution (HA) score is calculated by summing the items assessing direct hostile intent and indirect hostile intent across the eight scenarios (2 items per vignette). Scores range from 0 to 48, with higher scores indicating a stronger tendency to interpret others' actions as intentionally hostile in ambiguous social situations. The questionnaire also includes additional items assessing instrumental attribution, benign attribution, and negative emotional responses, which will be analyzed exploratorily.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad Francisco de Vitoria
Lead sponsor
Asociación GINSO
Collaborator
La Caixa Foundation
Collaborator