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.
Juvenile violence constitutes a major public health and social challenge, with significant individual, societal, and economic consequences. In Spain, violent offenses committed by adolescents account for approximately 5% of all registered crimes, and official data indicate a marked increase in youth violence over the past decade. Both perpetrators and victims are frequently minors, particularly in contexts such as bullying, physical assault, dating violence, and youth gang-related offenses. Beyond its immediate impact on victims, juvenile violence is strongly associated with adverse developmental trajectories for offenders, including academic failure, social exclusion, mental health problems, and an elevated risk of persistent criminal behavior into adulthood. Adolescence represents a critical developmental period characterized by heightened emotional reactivity, ongoing neurobiological maturation, and increased sensitivity to environmental influences. Individuals who display stable patterns of violent and antisocial behavior in adulthood often begin exhibiting aggressive conduct during adolescence. Consequently, early identification and intervention with young offenders are essential to prevent the consolidation and chronicity of aggressive behaviors. Interventions targeting this population have the potential not only to improve individual outcomes but also to reduce recidivism and enhance public safety. To date, a range of psychosocial interventions aimed at reducing aggression in adolescents has demonstrated some degree of effectiveness. Programs focusing on cognitive-behavioral strategies, emotional regulation, social skills training, and problem-solving have yielded positive outcomes, particularly when delivered in a targeted and time-limited manner to high-risk youth. However, meta-analytic evidence suggests that the magnitude of these effects is generally small to moderate, highlighting important limitations in current treatment approaches. Factors such as low treatment adherence, reduced motivation, difficulties in generalizing learned skills to real-life situations, and limited engagement with traditional therapeutic formats may partially account for these modest outcomes, especially in adolescents involved in the juvenile justice system. In response to these challenges, there is growing interest in the integration of innovative technological tools to enhance the effectiveness of psychosocial interventions. Virtual Reality (VR) has emerged as a promising therapeutic modality due to its capacity to generate immersive, interactive, and ecologically valid environments that simulate real-world situations. VR facilitates experiential learning by allowing users to engage in realistic scenarios while maintaining a high level of experimental and clinical control. This technology has demonstrated effectiveness as an adjunctive tool in psychological treatments, particularly for anxiety disorders, phobias, post-traumatic stress disorder, and substance use disorders. More recently, VR-based interventions have been developed to address aggression-related processes, including emotional awareness, physiological arousal regulation, empathy enhancement, and assertive interpersonal skills. Despite these promising developments, the empirical evidence supporting the use of VR in the treatment of juvenile violence remains limited. Existing VR-based programs often focus on specific components (e.g., empathy induction or anger management), are not fully integrated into structured therapeutic protocols, or have not been specifically designed for adolescent populations. Moreover, few studies have evaluated the added value of VR when embedded within multicomponent interventions, and even fewer have been conducted within secure or semi-secure juvenile justice settings or adapted to the Spanish sociocultural context. As a result, there is a clear need for rigorous, well-controlled studies that assess the effectiveness of VR-enhanced interventions for aggressive behavior in youth offenders. The present project seeks to address these gaps by conducting a randomized controlled trial (RCT) with three parallel arms in adolescents residing in three juvenile offender facilities. The primary objective of the study is to evaluate whether a multicomponent psychosocial intervention incorporating Virtual Reality is more effective in reducing aggressive behavior than both treatment as usual (TAU) and an active control intervention. Secondary objectives include examining changes in relevant psychological variables (e.g., emotional regulation, impulsivity, empathy, hostility, and social problem-solving) and neurophysiological biomarkers associated with aggression, as well as identifying predictors of treatment response and therapeutic prognosis. The study will employ a three-arm randomized controlled design with parallel groups. Participants will be recruited from three juvenile offender facilities and randomly assigned to one of the following conditions: 1. Treatment as Usual (TAU): Participants will receive the standard intervention routinely provided at the facilities. 2. Active Control Intervention (General Intervention): Participants will receive a structured multicomponent intervention of 4 training sessions. 3. Multicomponent Intervention with Virtual Reality: Participants will receive the same structured psychosocial intervention as the active control group, supplemented with VR-based modules specifically designed to address aggression-related processes. These modules will provide immersive simulations of high-risk interpersonal situations, allowing participants to practice. This arm is structured in the same 4 training sessions. Randomization will be conducted at the individual level, and allocation concealment procedures will be implemented to minimize selection bias. Outcome assessors will be blinded to group assignment whenever feasible. The primary outcome of the study will be the reduction of aggressive behavior, The ethical conduct of the study will adhere to national and international guidelines for research involving minors and justice-involved populations. Informed consent will be obtained from participants and their legal guardians, and all procedures will prioritize participant safety, confidentiality, and well-being. From a social perspective, the project has significant relevance. Effective interventions for juvenile offenders can reduce recidivism, improve reintegration outcomes, and decrease the long-term societal costs associated with violence and criminal behavior. By rigorously evaluating an innovative VR-enhanced intervention, this study has the potential to inform evidence-based practice within juvenile justice systems and to support the implementation of more effective, engaging, and developmentally appropriate treatment programs. This project is expected to make several key contributions to the field. First, it will provide high-quality empirical evidence regarding the effectiveness of a multicomponent VR-enhanced intervention compared to both TAU and active control condition. Second, it will contribute to the understanding of psychological and neurophysiological mechanisms underlying changes in aggressive behavior among adolescents. Third, by employing a novel VR software specifically designed for juvenile offenders and adapted to the Spanish context, the study will offer a scalable and transferable intervention model with potential applicability in other settings. In summary, this randomized controlled trial aims to advance both scientific knowledge and clinical practice by addressing a pressing social problem through the integration of innovative technology and evidence-based psychological intervention. In addition, this project brings together two entities: the GINSO association, the Innovae Group company that creates VR software, and the university research team. The GINSO Association has more than 20 years of experience in managing intervention programs aimed at minors and young people in vulnerable situations. It has a comprehensive approach that encompasses juvenile justice, child protection, and child and adolescent mental health, with the treatment of violence being a cross-cutting objective in all its programs. The results of the study could improve the organization's practices in several ways. First, if the evaluation shows a significant improvement in the effectiveness of the programs, confirming that virtual reality (VR) is a useful and complementary approach to standard treatment, this technology could be integrated into general intervention programs. Second, updating tools would not only increase the effectiveness of treatments but also contribute to the training of the association's professionals, improving their technical skills to meet the needs of minors in the centers. In this context, it should be noted that there are specific lines of funding aimed at the technification and digitization of the third sector, promoted at both the national and European levels. In addition, this project brings together two entities: the GINSO association, the Innovae Group company that creates VR software, and the university research team. The GINSO Association has more than 20 years of experience in managing intervention programs aimed at vulnerable minors and young people. It has a comprehensive approach that encompasses juvenile justice, child protection, and child and adolescent mental health. The project will also allow UFV to transfer knowledge, impacting not only the academic sphere but also contributing to the strengthening of professional practices in this sector. Based on the collaboration between these entities, new VR scenarios could be developed to address specific forms of violence, such as bullying and gender violence, as well as other antisocial behavior problems, such as drug use. Finally, the results of the research may influence public policies related to the treatment of youth violence. It is essential to prioritize access to innovative treatments, especially for people with limited economic resources, as is the case for most users of the centers managed by the GINSO Association.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
110
This 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.
This 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.
Participants 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.
Universidad Francisco de Vitoria
Pozuelo de Alarcón, Cominity of Madrid, Spain
RECRUITINGOverall 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.
Time frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
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.
Time frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
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.
Time frame: Baseline, post-intervention (4 weeks), and 3-month follow-up
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.
Time frame: Baseline (3 months prior to intervention), during the intervention (up to 4 weeks), and post-intervention (up to 3 months after intervention)
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.
Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up
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.
Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up
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.
Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up
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.
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Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up
Emotion regulation difficulties measured with the Difficulties in Emotion Regulation Scale - Short Form (DERS-28)
The Difficulties in Emotion Regulation Scale - Short Form (DERS-28) is a self-report questionnaire consisting of 28 items rated on a 5-point Likert scale (1-5). Total scores range from 28 to 140, with higher scores indicating greater difficulties in emotion regulation. The instrument assesses multiple dimensions of emotion regulation difficulties, including nonacceptance of emotional responses, difficulties engaging in goal-directed behavior, impulse control difficulties, limited access to emotion regulation strategies, lack of emotional awareness, and lack of emotional clarity.
Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up
Impulsivity measured with the Barratt Impulsiveness Scale (BIS-11)
The Barratt Impulsiveness Scale (BIS-11) is a 30-item self-report questionnaire designed to assess trait impulsivity. Items are rated on a 4-point Likert scale, and total scores range from 30 to 120, with higher scores indicating greater impulsivity. The scale assesses different facets of impulsivity, including attentional impulsivity, motor impulsivity, and non-planning impulsivity.
Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up
Alcohol use measured with the Alcohol Use Disorders Identification Test (AUDIT)
The Alcohol Use Disorders Identification Test (AUDIT) is a 10-item self-report questionnaire developed by the World Health Organization to screen for hazardous and harmful alcohol consumption. Items are rated on a Likert-type scale and total scores range from 0 to 40, with higher scores indicating greater risk of problematic alcohol use.
Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up.
Cannabis use measured with the Cannabis Abuse Screening Test (CAST)
The Cannabis Abuse Screening Test (CAST) is a self-report questionnaire consisting of 6 items designed to assess problematic cannabis use. Items are rated on a Likert-type scale and total scores range from 0 to 24, with higher scores indicating greater risk of problematic cannabis use.
Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up.
Emotion recognition measured with the FACES Test (Baron-Cohen)
The FACES Test is a performance-based task designed to assess facial emotion recognition. Participants view 20 photographs of human faces displaying emotional expressions and are asked to identify the emotion shown by selecting one of two response options. The outcome corresponds to the number of correctly identified emotional expressions (range 0-20), with higher scores indicating better emotion recognition ability.
Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up
Emotion recognition measured with the FACE Test
The FACE Test is a performance-based task that assesses recognition of complex mental states from facial expressions. The task consists of 36 photographs derived from the McGill Face Database, depicting facial expressions of mental states interpreted by one male and one female actor. Participants are required to identify the mental state expressed in each photograph. The outcome corresponds to the accuracy score (number of correct responses; range 0-36), with higher scores indicating better ability to recognize complex emotional and mental states from facial expressions.
Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up
Readiness to change measured with the University of Rhode Island Change Assessment (URICA)
Readiness to change problematic behavior will be assessed using the University of Rhode Island Change Assessment (URICA), a 32-item self-report questionnaire based on the transtheoretical model of behavioral change developed by Prochaska and DiClemente. Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). The instrument assesses four stages of change: precontemplation, contemplation, action, and maintenance, with 8 items per stage. Separate scores are obtained for each stage, allowing the identification of the individual's stage of readiness for behavioral change. Higher scores in the action and maintenance stages indicate greater engagement in behavioral change, whereas higher scores in precontemplation reflect lower recognition of the problem and lower readiness to change.
Time frame: Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up
Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ-8)
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report questionnaire designed to assess participants' satisfaction with a service or intervention. Items are rated on a Likert-type scale (range 1-10), and the total score ranges from 8 to 80, with higher scores indicating greater satisfaction with the intervention.
Time frame: Post-intervention (4 weeks) and 3-month follow-up
Salivary cortisol levels
Physiological stress response will be assessed through salivary cortisol levels obtained using saliva collection devices (Salivette, Sarstedt). Cortisol is a hormone released in response to stress and reflects activation of the hypothalamic-pituitary-adrenal (HPA) axis. Saliva samples will be collected before the task, immediately after the task, and 15 minutes after the task during both the initial and final assessments. Unit of measure: μg/dL. Higher cortisol levels indicate greater physiological stress response.
Time frame: Baseline assessment (pre-task, immediately post-task, and 15 minutes post-task), final assessment (pre-task, immediately post-task, and 15 minutes post-task) and 3-month follow-up (pre-task, immediately post-task, and 15 minutes post-task).
Salivary alpha-amylase activity
Autonomic stress response will be measured through salivary alpha-amylase activity, collected using saliva sampling devices (Salivette, Sarstedt). Alpha-amylase is a biomarker of sympathetic nervous system activation and is commonly used as an indicator of acute stress reactivity. Samples will be obtained before the task, immediately after the task, and 15 minutes after the task during both the baseline and final assessments. Unit of measure: U/mL. Higher values indicate greater sympathetic activation.
Time frame: Baseline assessment (pre-task, immediately post-task, and 15 minutes post-task), final assessment (pre-task, immediately post-task, and 15 minutes post-task) and 3-month follow-up (pre-task, immediately post-task, and 15 minutes post-task).
Salivary testosterone levels
Salivary testosterone levels will be assessed as a biomarker associated with physiological activation during anger-inducing tasks. Saliva samples will be collected using Salivette devices (Sarstedt) before the task, immediately after the task, and 15 minutes after the task during both baseline and final assessments. Testosterone concentrations will be expressed in pg/mL. Changes in testosterone levels will be examined to evaluate physiological responses associated with emotional activation.
Time frame: Baseline assessment (pre-task, immediately post-task, and 15 minutes post-task), final assessment (pre-task, immediately post-task, and 15 minutes post-task) and 3-month follow-up (pre-task, immediately post-task, and 15 minutes post-task).
REsting heart rate.
Heart rate will be recorded using a Polar H10 heart rate monitor. Participants will undergo a 5-minute resting recording during both baseline and final assessments. Heart rate provides an indicator of physiological activation and autonomic nervous system activity. Unit of measure: beats per minute (bpm). Higher values indicate greater physiological arousal.
Time frame: Baseline assessment (5-minute resting recording), post-intervention assessment (5-minute resting recording) and 3-month follow-up (5-minute resting recording)
Heart rate variability (RMSSD and SDNN)
Heart rate variability (HRV) will be derived from ECG signals recorded with a Polar H10 heart rate monitor and analyzed using Kubios HRV software. HRV indices will include RMSSD (root mean square of successive differences) and SDNN (standard deviation of normal-to-normal intervals). HRV reflects autonomic nervous system functioning. Higher HRV values generally indicate greater parasympathetic activity and better autonomic regulation.
Time frame: Baseline assessment (5-minute resting recording), post-intervention assessment (5-minute resting recording) and 3-month follow-up (5-minute resting recording)
Frontal and temporal cortical activity measured with EEG
Cortical activity will be recorded using a Muse 2 electroencephalography (EEG) device with four dry electrodes. EEG signals will be collected during a 5-minute resting recording at baseline and post-intervention. Relative spectral power will be calculated for the main frequency bands (delta, theta, alpha, beta, and gamma). These measures reflect neural activity associated with cognitive processing and emotional regulation.
Time frame: Baseline assessment (5-minute resting recording), post-intervention assessment (5-minute resting recording) and 3-month follow-up (5 minute resting recording)