Life Skills-Based Intervention on Substance Use Intention in Adolescents in Social Care Institutions

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUniversidad Autonoma de Baja California

About this trial

Objective: evaluate the impact of a Life Skills Training (LST) intervention on substance use intention by analyzing changes in neuropsychological organization and psychological regulation processes in adolescents living in social assistance institutions.Methodology Design: Parallel-group randomized controlled trial with a 1:1 allocation ratio. Participants: 20 adolescents aged 12 to 17 with a minimum of 3 months of residence in foster care homes in Mexicali, Baja California.Intervention: The experimental group will undergo 8 sessions (60 minutes each) of LST, while the control group will receive a traditional psychoeducational intervention of the same duration.Key Measures: Electroencephalography (EEG) will be used to monitor cortical maturation (Alpha/Theta power) and frontal asymmetry. Clinical scales including DERS, DUSI, BANFE-2, and substance use intention questionnaires will also be administered.RationaleIn Mexico, the average age of onset for substance use has dropped to 12-13 years. Institutionalized adolescents face heightened vulnerability due to histories of trauma, neglect, and environmental exposure to high-lethality substances such as fentanyl and methamphetamines in the border region

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adolescents aged 12 to 17 who have lived in the participating children's home.

Ability to understand and respond to the tests and questionnaires administered during the study.

Approval and signature of the director or legal guardians of the social welfare institutions on the informed consent form.

Disqualifiers

Adolescents diagnosed with externalizing disorders, intellectual disabilities, or severe or serious psychiatric disorders that prevent them from understanding the intervention protocol.

Adolescents who are undergoing administrative processes such as family reintegration or imminent relocation that make it difficult to complete the assessments.

Participation in other studies that interfere with the application of the assessment instruments.

Situations of acute emotional, medical, or behavioral crisis observed by the administrative staff of social welfare institutions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Life Skills Training (LST)

    Behavioral

    Life Skills Training (HpV - Habilidades para la Vida). Format: 8 sessions, 60 minutes over eigth weeks once a week.Core Components:Emotional Regulation: Techniques to identify and manage emotions to reduce impulsivity.Inhibitory Control: Cognitive exercises to improve decision-making and resistance to immediate rewards.Social Skills: Training in assertiveness and resistance to peer pressure.Critical Thinking: Evaluating the consequences of substance use beyond standardized information.

  • Psicoeducation Traditional

    Behavioral

    This program consists of 8 sessions of 60 minutes over eigth weeks once a week, delivered with the same frequency and duration as the experimental group to control for social interaction and time effects. The content is based on traditional health education models, focusing on providing standardized information about the biological, social, and legal risks associated with substance use. Unlike the experimental arm, this program does not include specific training in emotional regulation or inhibitory control techniques, focusing strictly on informative and awareness-building lectures regarding the consequences of drug consumption

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Life Skills Training (LST)Experimental treatment 1 intervention
Group B: Psychoeducation TraditionalActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Substance Use Intention Score

Evaluated using the Substance Use Intention Questionnaire (Cuestionario de Intención de Consumo). This scale measures the psychological predisposition toward using alcohol, tobacco, or illicit drugs. Metric: Change from baseline in the total score of the scale (higher scores indicate higher intention to consume) .Low Intention (Normal): Scores between 12 and 24 points, indicating a clear rejection of future substance use.Moderate Intention: Scores between 25 and 36 points.High Intention (Risk): Scores $\> 36$ points. This cut-off represents the theoretical median of the scale and is used as an indicator of high vulnerability and positive predisposition toward consumption.

Time frame
Baseline (Week 0) and post-intervention (Week 8)
2

Inhibitory Control Performance

Iowa Gambling Test, will be measured by calculating EF quotients from the standardized test BANFE-2 (Flores Lázaro, J. C., Ostrosky Shejet, F., \& Lozano Gutiérrez, A) using risk cards percentage, final total score. Total score is transformed to normalized points 0-19 (with a mean of 10 ±3 SD, 4-6 low, 14-19 high performance).

Time frame
Baseline (Pre-intervention) and 8 weeks (Post-intervention)
3

Substance Use and pshycosocial risk level

Drug Use Screening Inventory (DUSI-R). This is a 149-item self-report questionnaire with dichotomous (Yes/No) responses that screens for severity in 10 functional domains, including substance use, behavior, family system, and social competency. The index is calculated as the percentage of "Yes" responses, where a higher percentage indicates a Validated cut-off points for the Mexican adolescent population are used. In research terms, a Severity Index \> 20% in specific areas or in the overall score usually indicates a risk requiring immediate clinical attention.higher level of dysfunction or severity in the adolescent's life.

Time frame
Baseline (Week 0) and post-intervention (Week 8)

Secondary outcomes

1

Absolute and relative power in Alpha and Theta bands

Neurophysiological electroencephalographic (EEG) recordings will be performed. Each participant will undergo a five-minute EEG. Cortical electrical activity will be evaluated using the Emotiv EPOC X wireless system. This device uses 14 fixed, saline-based electrodes. Data will be sampled at 256 Hz with a 16-bit analog-to-digital converter (ADC) resolution. The recording will be taken at AF3, AF4, F3, F4, F7, F8, FC5, and FC6. The assessment will focus on resting-state activity to identify biomarkers of self-regulation. Higher alpha power (8-13 Hz) is associated with cognitive readiness, while lower alpha power often indicates deficits in institutionalized populations. Theta power (4-8 Hz) Excess power in central regions is a marker of cortical "slowing" or immaturity. Frontal Alpha Asymmetry (FAA): It is calculated as the difference in alpha power between the right and left frontal hemispheres and is used as a biomarker for anxiety and emotional dysregulation.

Time frame
Baseline (Pre-intervention) and 8 weeks (Post-intervention)
2

Change in Emotional Dysregulation Level

Difficulties in Emotion Regulation Scale (DERS-E) validated for the Mexican population. This 24-item self-report instrument measures participants' challenges in regulating their emotions across four critical domains: non-acceptance of emotional responses, interference with goal-directed behaviors, lack of emotional awareness, and lack of emotional clarity. For the purposes of this study, a cutoff score of 73 points or higher will be considered an indicator of clinically significant emotional dysregulation (High Risk).

Time frame
Baseline (Week 0) and Week 8 (post-intervention)
3

Life Skills Development

It will be evaluated using the Brief Life Skills Scale (EB-HPV), validated for the Mexican population. The instrument measures 10 dimensions. It is a self-report instrument consisting of 40 items with a 5-point Likert-type response scale (1: Never to 5: Always). The use of this brief scale minimizes participant fatigue bias in extensive clinical protocols. It has an overall internal consistency of w= 0.95% and a confirmed factorial structure that ensures that changes observed in scores reflect actual changes in the psychosocial. The total score is normally categorized into three levels based on the percentile distribution of the Mexican population: Level Score Range Clinical Interpretation Low 40-113 points Skill deficit. The adolescent shows difficulties in adapting to social and emotional demands. Requires priority intervention. Average 114-156 points Functional skills.

Time frame
Baseline (Week 0) and post-intervention (Week 8)

Other outcomes

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