NCT07484919

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Dec 2025Oct 2026

Study Start

First participant enrolled

December 15, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

February 9, 2026

Last Update Submit

March 17, 2026

Conditions

Keywords

youth violencevirtual realityjuvenile offenders

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Baseline (3 months prior to intervention), during the intervention (up to 4 weeks), and post-intervention (up to 3 months after intervention)

Secondary Outcomes (18)

  • Trait anger measured with the State-Trait Anger Expression Inventory-2 (STAXI-2)

    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)

    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)

    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)

    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)

    Baseline (pre-intervention), post-intervention (4 weeks), and 3-month follow-up

  • +13 more secondary outcomes

Study Arms (3)

Treatment as Usual + Virtual Reality Intervention

EXPERIMENTAL

Participants receive treatment as usual plus a 4-session program using virtual reality (VR). This arm is different from the others because it includes VR to practice recognizing emotions, managing anger, and resolving conflicts in a simulated environment.

Behavioral: Virtual Reality

Treatment as Usual + Non-VR Intervention

ACTIVE COMPARATOR

Participants receive treatment as usual plus the same 4-session program without virtual reality. This arm allows comparison of the program's effects without using VR technology.

Behavioral: Active Control

Treatment as usual Only

OTHER

Participants receive only treatment as usual provided at the juvenile center. This arm serves as a reference to evaluate the additional effects of the intervention program with or without virtual reality.

Behavioral: Treatment as usual

Interventions

Virtual RealityBEHAVIORAL

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.

Treatment as Usual + Virtual Reality Intervention
Active ControlBEHAVIORAL

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.

Treatment as Usual + Non-VR Intervention

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.

Treatment as usual Only

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Neurological disorder, brain injury, or psyquiatric pathology that affects cognitive functions or advises against use of virtual reality.
  • Not being fluent in Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, Cominity of Madrid, 28223, Spain

RECRUITING

Related Publications (1)

  • Roncero, D., Moreno-Fernandez, R. D., & Fernandez-Moreno, A. (2025). Effectiveness of Virtual Reality interventions for aggression, anger and impulsiveness: A multilevel meta-analysis. Aggression and Violent Behavior, 102034. https://doi.org/10.1016/j.avb.2025.102034

    BACKGROUND

Related Links

MeSH Terms

Conditions

Aggression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Aberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • David Roncero Villarreal, PhD

    Universidad Francisco de Vitoria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Roncero Villarreal, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 9, 2026

First Posted

March 20, 2026

Study Start

December 15, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly due to the highly vulnerable nature of the study population, which consists of minors (aged 12-18 years) under judicial custody. The data collected are sensitive and include mental health information, psychophysiological measures, and records of aggressive behavior within the juvenile justice system. Informed consent signed by participants and their legal guardians restricts data use to the research teams of Universidad Francisco de Vitoria and GINSO. Restricting data access ensures compliance with data protection regulations (GDPR and Spanish data protection law) and protects participants' privacy. In line with the principle of responsible openness, study results will be disseminated in aggregated and anonymized form. Any exceptional access to anonymized data would require a justified request to the Principal Investigator and evaluation under scientific, ethical, and legal criteria.

Locations