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Life Skills-Based Intervention on Substance Use Intention in Adolescents in Social Care Institutions (CASA-HpV) 20 Randomized Adolescent

Not yet recruiting
Clinical Trial NCT07492069 (CASA-HpV) is an interventional study for Institutionalization and is currently not yet recruiting. Enrollment is planned to begin on 30 August 2026 and continue until the study accrues 20 participants. Led by Universidad Autonoma de Baja California, this study is expected to complete by 15 March 2027. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
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 r...Show More
Detailed Description
Adolescence is a vital stage characterized by biopsychosocial changes, marking the transition from childhood to adulthood. Recent decades have shown demographic and epidemiological shifts associated with morbidity and mortality in this group. Health problems in this age range are often determined by risk behaviors such as substance use, sedentary lifestyles, poor nutrition, and risky sexual behaviors.During this stag...Show More
Official Title

Inhibitory Control, Emotional Regulation, and Peer Pressure: Neurophysiological and Psychological Effects of a Life Skills Intervention to Reduce Substance Use Intention in Institutionalized Children a Randomized Clinical Trial.

Conditions
Institutionalization
Other Study IDs
  • CASA-HpV
  • MP/2026/LIRU
NCT ID Number
Start Date (Actual)
2026-08-30
Last Update Posted
2026-03-25
Completion Date (Estimated)
2027-03-15
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Children,
Institutionalization
Life Skills Training
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalLife Skills Training (LST)
Institutionalized adolescents receiving a life skills-based intervention. The program focuses on strengthening inhibitory control, emotional regulation, and social skills to reduce substance use intention. This program consist of 8 sessions of 60 minutes over eight weeks once a week. Unlike the active comparator, this arm focuses on practical behavioral training, specifically incorporating assertiveness techniques, r...Show More
Life Skills Training (LST)
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: Evaluat...Show More
Active ComparatorPsychoeducation Traditional
Participants receive standard prevention information about the risks and consequences of drugs use, following traditionals health educations models. This program consist of 8 sesions of 60 minutes over eight weeks once a week. Unlike the experimental arm, this program focuses strictly on informative lectures and awareness-building, without any behavioral skills-training component.
Psicoeducation Traditional
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, t...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Baseline (Week 0) and post-intervention (Week 8)
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).
Baseline (Pre-intervention) and 8 weeks (Post-intervention)
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.
Baseline (Week 0) and post-intervention (Week 8)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Baseline (Pre-intervention) and 8 weeks (Post-intervention)
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).
Baseline (Week 0) and Week 8 (post-intervention)
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.
Baseline (Week 0) and post-intervention (Week 8)
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
12 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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.

Informed consent of the adolescent.

  • 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.
Universidad Autonoma de Baja California logoUniversidad Autonoma de Baja California
Study Responsible Party
Gilberto Galindo, Principal Investigator, Full time Research, Universidad Autonoma de Baja California
Study Central Contact
Contact: Ulises Alejandro Licea Rodriguez, Pshycologist, +526861917559, [email protected]
1 Study Locations in 1 Countries

Estado de Baja California

Universidad Autonoma de Baja California, Facultad de Ciencias Administrativas, sociales e ingenieria, Mexicali, Estado de Baja California, 21720, Mexico