NCT07492069

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 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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

August 30, 2026

Expected
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

March 31, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

March 19, 2026

Last Update Submit

March 25, 2026

Conditions

Keywords

Children,InstitutionalizationLife Skills Training

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Absolute and relative power in Alpha and Theta bands

    Baseline (Pre-intervention) and 8 weeks (Post-intervention)

  • Change in Emotional Dysregulation Level

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

  • Life Skills Development

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

Study Arms (2)

Life Skills Training (LST)

EXPERIMENTAL

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, resistance to peer pressure, and cognitive exercises for decision-making.

Behavioral: Life Skills Training (LST)

Psychoeducation Traditional

ACTIVE COMPARATOR

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.

Behavioral: Psicoeducation Traditional

Interventions

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.

Life Skills Training (LST)

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

Psychoeducation Traditional

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Autonoma de Baja California, Facultad de Ciencias Administrativas, sociales e ingenieria

Mexicali, Estado de Baja California, 21720, Mexico

Location

Central Study Contacts

Ulises Alejandro Licea Rodriguez, Pshycologist

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full time Professor

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start (Estimated)

August 30, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

March 15, 2027

Last Updated

March 31, 2026

Record last verified: 2026-01

Locations