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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-21
SponsorUniversidad Francisco de Vitoria

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

13-21 years old

Admited in a residencial intervention program

Prevision of a >6 month stay

Alcohol and/or cannabis use

Disqualifiers

Psychiatric or neurological pahology that affects cognitive functions

Not being fluent in Spanish

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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 groups

50 Participants
are divided into 2 treatment groups
Group A: VR intervention + Treatment as UsualExperimental treatment 1 intervention
Group B: Treatment as usualOther 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Inventory of Callous-Unemotional Traits (ICU)

The ICU is a self-reported, 24-item questionnaire that includes three subscales: Callousness (lack of empathy and remorse, callous use of others), Uncaring (lack of concern about performance and other's feelings), and Unemotional (reduced emotional expression and shallow affect). Each item is rated on a 4-point Likert scale from 0 (not true at all), to 3 (definitely true).

Time frame
Baseline (pre-intervention)
2

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)
3

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)
4

Impulsive behavior measured with the UPPS-P short version

The UPPS-P Impulsive Behavior Scale consits of 20 items that measure five distint impulsivity traits: negative urgency, lack of premeditation, lack of perseverance, sensation seeking, and positive urgency. The scale is scored on a 4 point Likert scake, ranging from 1 (strongly agree) to 4 (strongly disagree).

Time frame
Baseline (pre-intervention)

Other outcomes

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