Virtual Reality (VR-GINSO) as an Complement to Intervention for Alcohol and Cannabis Use in Youth in Residential Care

NCT07834606 | Recruiting DMC

• 1 other identifier: UFV48/2024-2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this RCT is to evaluate the effects of a virtual reality intervention on self-efficacy regarding alcohol and cannabis use among at-risk youth in various residential mental health treatment centers who have co-occurring disorders and are under the care of the association where they receive treatment. The main question it aims to answer is: • Does the VR intervention enhance the therapeutic effect of residential treatment on self-efficacy regarding alcohol and cannabis use? If there is a comparison group: Researchers will compare the intervention with the usual care (UC) that minors receive at the centers for the treatment of dual diagnosis to see if VR adds value to this treatment. Participants will be randomly assigned to each condition and will be evaluated before and after one month. In the experimental group, participants will receive a treatment session using VR software, during which they will undergo training in the following modules: The first phase is an assessment phase, during which objective measures are determined for 1) emotional recognition, 2) avoidance/approach toward related stimuli, 3) degree of compliance with social pressure, and 4) craving in the presence of the drug, exposure to cues, and/or conditioned contexts.

Conditions

Dual Diagnosis; Risk Youth; Antisocial Behavior

Keywords

Drug use; Alcohol use; Cannabis use; Virtual reality; risk youth; Dual patology

Outcome Measures

Primary Outcomes (1)

• Self-Efficacy for Drug Taking measured with Drug-Taking Confidence Questionnaire (DTCQ-8)

  The Drug-Taking Confidence Questionnaire (DTCQ) measures the self-efficacy of individuals regarding their ability to resist drug use.

  Baseline (pre-intervention), Intervention (pre-post), Post. Up to 12 weeks

Secondary Outcomes (15)

• Inventory of Callous-Unemotional Traits (ICU)

  Baseline (pre-intervention)

• Alcohol use measured with the Alcohol Use Disorders Identification Test (AUDIT)

  Baseline (pre-intervention)

• Cannabis use measured with the Cannabis Abuse Screening Test (CAST)

  Baseline (pre-intervention)

• Impulsive behavior measured with the UPPS-P short version

  Baseline (pre-intervention)

• Trait Anxiety measured with the State-Trait Anxiety Expression Inventory (STAI)

  STAI-Trait: Baseline (pre-intervention). STAI-STATE: Intervention (pre-post)

Study Arms (2)

VR intervention + Treatment as Usual

EXPERIMENTAL

Participants receive treatment as usual plus one VR session. This arm includes VR to practice emotion recognition, and management of risk situations for substance use.

Behavioral: Virtual Reality

Treatment as usual

OTHER

Participants receive treatment as usual, no other additional intervention.

Behavioral: Treatment as Usual (TAU)

Interventions

Virtual Reality BEHAVIORAL

This group will undergo a 1 individual session with a Virtual Reality program targeting emotion recognition, training on avoidance-approximation to associated stimuli, and exposure to conditioned contexts for substance use. During this session, participants will train specific abilities throug various activities. The tasks have been designed as a serious game in a Virtual Reality setting and include: emotion identification and recognition, practicing avoidance of conditioned substance use stimuli, and approximation to neutral stimuli, and exposure to conditioned situations to train regulation and management abilities for craving.

VR intervention + Treatment as Usual

Treatment as Usual (TAU) BEHAVIORAL

Participants in this group will receive treatment as usual provided by the facility, with no additional intervention. Treatment will be delivered ober the same period of time as in the other study group. Participants will complete one baseline assessment before the study period, and one post-intervention assessment.

Treatment as usual

Eligibility Criteria

• Age: 13 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Admited in a residencial intervention program
• Prevision of a \>6 month stay
• Alcohol and/or cannabis use

You may not qualify if:

• Psychiatric or neurological pahology that affects cognitive functions
• Not being fluent in Spanish

Sponsors & Collaborators

• Universidad Francisco de Vitoria: lead
• Asociación GINSO: collaborator

Study Sites (1)

Universidad Francisco de Vitoria

Pozuelo de Alarcón, 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

MeSH Terms

Conditions

Antisocial Personality Disorder; Alcohol Drinking

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Drinking Behavior; Behavior

Central Study Contacts

Román Darío Moreno Fernández

CONTACT

+34686531209; romandario.moreno@ufv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UFV

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 22, 2026
• Study Start: December 10, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)