Virtual Reality (VR-GINSO) as an Complement to Intervention for Alcohol and Cannabis Use in Youth in Residential Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Self-Efficacy for Drug Taking measured with Drug-Taking Confidence Questionnaire (DTCQ-8)
研究概览
简要总结
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.
详细描述
Adolescence constitutes a developmental stage characterized by heightened neurobiological and psychosocial vulnerability. During this period, significant maturational changes occur at the cerebral, emotional, and social levels, increasing susceptibility to the development of risk behaviors and mental health problems. Among these behaviors, antisocial conduct and substance use are particularly prominent, frequently emerging in an interconnected manner.
Adolescents and young people are at high risk of engaging in health-damaging behaviors, especially antisocial behavior and drug use. In this regard, juvenile offenders and youths involved in the juvenile justice system display significantly higher rates of substance use than the general population, particularly alcohol and cannabis consumption. Previous research has consistently shown that early substance use not only results from pre-existing psychosocial vulnerabilities, but also contributes to the perpetuation and aggravation of social exclusion, school dropout, violence, and criminal recidivism trajectories.
Scientific literature has demonstrated a strong association between mental disorders and substance use in adolescent populations. In particular, externalizing disorders such as Attention-Deficit/Hyperactivity Disorder (ADHD) and conduct disorder exhibit the strongest association with substance abuse. These disorders are characterized by impaired inhibitory control, impulsivity, sensation seeking, and emotional dysregulation, all of which increase vulnerability to early initiation of substance use and the subsequent development of addictive behaviors.
Moreover, there is a significant relationship between substance use and other psychopathological conditions, including depression, anxiety, and trauma-related symptoms. Many adolescents engage in substance use as a maladaptive emotional coping strategy, especially in contexts characterized by psychosocial adversity, family neglect, victimization, or early traumatic experiences. This bidirectional interaction between psychopathology and substance use contributes to the emergence of dual pathology, thereby complicating both clinical progression and therapeutic intervention.
When substance use emerges during adolescence in association with socially disadvantaged environments and antisocial behavior, treatment becomes particularly challenging due to its multifactorial nature. Individual, familial, social, and neurobiological factors interact dynamically, facilitating the chronicity of the problem. Furthermore, early substance use has been identified as a relevant factor in the persistence of antisocial behavior into adulthood, increasing the risk of social exclusion, unemployment, interpersonal conflict, and psychiatric disorders later in life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 21 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •13-21 years old
- •Admited in a residencial intervention program
- •Prevision of a >6 month stay
- •Alcohol and/or cannabis use
排除标准
- •Psychiatric or neurological pahology that affects cognitive functions
- •Not being fluent in Spanish
研究组 & 干预措施
Treatment as usual
Participants receive treatment as usual, no other additional intervention.
干预措施: Treatment as Usual (TAU) (Behavioral)
VR intervention + Treatment as Usual
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.
干预措施: Virtual Reality (Behavioral)
结局指标
主要结局
Self-Efficacy for Drug Taking measured with Drug-Taking Confidence Questionnaire (DTCQ-8)
时间窗: Baseline (pre-intervention), Intervention (pre-post), Post. Up to 12 weeks
The Drug-Taking Confidence Questionnaire (DTCQ) measures the self-efficacy of individuals regarding their ability to resist drug use.
次要结局
- 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))
- Motivation to quit using measured by Motivation Test to Quit-Richmond(Baseline (pre-intervention), Post. Up to 12 weeks.)
- Craving using an Analogue Craving Scale(Baseline (pre-intervention), Intervention (pre-post and during tasks). Up to 12 weeks)
- Motion sickness to VR measured with Simulator Sickness Questionnaire (SSQ)(Intervention (post). Up to 12 weeks)
- Presence in VR measured with Multimodal Presence Scale (MPS)(Intervention (post))
- Salivary cortisol levels(Intervention (pre-task, immediately post-task, and 15 minutes post-task))
- Salivary alpha-amylase activity(Intervention (pre-task, immediately post-task, and 15 minutes post-task))
- Salivary testosterone levels(Intervention (pre-task, immediately post-task, and 15 minutes post-task))
- Resting heart rate(Intervention (5 minutes post-task), Post for control group (5 minutes). Up to 12 weeks.)
- Heart rate variability (RMSSD and SDNN)(Intervention (during tasks). Up to 12 weeks.)
- Frontal and temporal cortical activity measured with EEG(Intervention (during tasks, post-tasks - 5 minutes resting), Post-control group (5 minutes-resting). Up to 12 weeks.)
研究者
Roman Dario Moreno Fernandez
UFV
Universidad Francisco de Vitoria
