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Набор скоро начнётся NCT07492069

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

Без фазы С лечением Institutionalization

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Life Skills Training (LST), Psicoeducation Traditional.
Кому может быть актуально
Состояния в реестре: Institutionalization. Базовые параметры: 12 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Мексика
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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.

Обзор

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

Подробное описание

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 stage, impulsivity, sensation-seeking, and exposure to social pressure increase the likelihood of engaging in risk behaviors. Studies based on the Theory of Planned Behavior (Ajzen, 1991) suggest that substance use intention-a cognitive, emotional, and social predisposition-is a key predictor of early consumption. This is particularly critical in adolescents due to the incomplete development of the prefrontal cortex, which limits inhibitory control and the ability to evaluate future consequences.Scientific evidence indicates that preventive programs based on life skills (LS)-such as self-regulation, decision-making, and peer pressure resistance-can effectively delay and reduce drug use. For example, Italian adaptations of LS training showed significant reductions in alcohol and tobacco use.Context in Mexico and Baja California National Level: The average age of drug use onset dropped from 20.7 years (2002) to 15.3 years (2023) among those receiving treatment. Common starter substances include alcohol (38.6%), tobacco (31.4%), and marijuana (16.8%). Methamphetamine use has increased by 218% between 2013 and 2022.Regional Level (Baja California): Methamphetamine is the primary health threat, representing 56.5% of specialized treatment demands. Fentanyl cases tripled from 3.8% in 2022 to 10.9% in 2024.Mexicali: 48.1% of the population identifies "street drug use" as the most frequent criminal behavior in their environment. Institutionalized adolescents in this region face high environmental availability of substances, increasing the risk of early use.

Problem Statement Research Question What are the psychological and neuropsychological effects of a life-skills-based intervention in institutionalized adolescents?

Specific Questions What is the effect of a Life Skills (LS) intervention on brain function organization?

What is the effect of an LS-based intervention on social skills?

What is the effect of a Life Skills intervention on inhibitory control?

What is the effect of an LS-based intervention on emotional regulation?

What effect do LS-based interventions generate on substance use intention?

Background 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 stage, impulsivity, sensation-seeking, and exposure to social pressure increase the likelihood of engaging in risk behaviors. Studies based on the Theory of Planned Behavior (Ajzen, suggest that substance use intention-a cognitive, emotional, and social predisposition-is a key predictor of early consumption. This is particularly critical in adolescents due to the incomplete development of the prefrontal cortex, which limits inhibitory control and the ability to evaluate future consequences.

Scientific evidence indicates that preventive programs based on life skills (LS)-such as self-regulation, decision-making, and peer pressure resistance-can effectively delay and reduce drug use. For example, Italian adaptations of LS training showed significant reductions in alcohol and tobacco use Context in Mexico and Baja California National Level: The average age of drug use onset dropped from 20.7 years (2002) to 15.3 years (2023) among those receiving treatment. Common starter substances include alcohol (38.6%), tobacco (31.4%), and marijuana (16.8%). Methamphetamine use has increased by 218% between 2013 and 2022.

Regional Level (Baja California): Methamphetamine is the primary health threat, representing 56.5% of specialized treatment demands. Fentanyl cases tripled from 3.8% in 2022 to 10.9% in 2024. Mexicali: 48.1% of the population identifies "street drug use" as the most frequent criminal behavior in their environment. Institutionalized adolescents in this region face high environmental availability of substances, increasing the risk of early use.

Objectives General Objective To evaluate the impact of a Life Skills (LS) intervention on substance use intention by analyzing changes in neuropsychological organization and psychological regulation processes in institutionalized adolescents.

Specific Objectives Analyze changes in general neurocognitive functioning after the LS intervention.

Determine the effect of the LS program on the participants' social skills. Evaluate the efficacy of the intervention in improving inhibitory control. Identify modifications in emotional regulation capabilities. Contrast pre- and post-intervention levels of substance use intention. JustificationAdolescents are vulnerable due to incomplete brain development, specifically in areas related to decision-making and inhibitory control. Institutionalized youth (those in group homes/shelters) face higher risks because of prior experiences with neglect, abandonment, family disintegration, or abuse. These factors negatively impact emotional self-regulation and social skills.Intervening in the intention to consume-the psychological stage preceding the behavior-has high preventive value. This study will contribute to the social protection of a vulnerable group by strengthening protective factors and potentially improving institutional coexistence and school performance.FeasibilityAccess: Participants are in a residential setting, which ensures availability for pre-tests, sessions, and post-tests, minimizing drop-out rates.Resources: The psychoeducational intervention is low-cost and does not require expensive technology. The researcher is supported by a National Graduate Scholarship (SECIHTI).Competencies: The researcher has the academic training in psychology and methodology required to work with vulnerable populations.MethodologyDesign: Parallel randomized clinical trial with a 1:1 allocation.Groups:Experimental Group: 8 sessions (60 min each) of Life Skills training.Control Group: 8 sessions of traditional psychoeducational intervention.Participants: 20 adolescents (ages 12-17) residing in non-profit group homes in Mexicali.

Вмешательства

  • Поведенческое 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: Evaluating the consequences of substance use beyond standardized information.
  • Поведенческое 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, this program does not include specific training in emotional regulation or inhibi

Первичные конечные точки

  • Change in Substance Use Intention Score [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
  • Inhibitory Control Performance [Срок оценки: Baseline (Pre-intervention) and 8 weeks (Post-intervention)]
  • Substance Use and pshycosocial risk level [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]
Вторичные конечные точки (3)
  • Absolute and relative power in Alpha and Theta bands [Срок оценки: Baseline (Pre-intervention) and 8 weeks (Post-intervention)]
  • Change in Emotional Dysregulation Level [Срок оценки: Baseline (Week 0) and Week 8 (post-intervention)]
  • Life Skills Development [Срок оценки: Baseline (Week 0) and post-intervention (Week 8)]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Мексика · 1 центр
  • Universidad Autonoma de Baja California, Facultad de Ciencias Administrativas, sociales e — Mexicali

Идентификаторы

NCT: NCT07492069 · MP/2026/LIRU

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗