Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:40 AM
Study NCT ID:
NCT07492069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-25
First Post:
2026-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Life Skills-Based Intervention on Substance Use Intention in Adolescents in Social Care Institutions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-19', 'studyFirstSubmitDate': '2026-03-19', 'studyFirstSubmitQcDate': '2026-03-19', 'lastUpdatePostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Substance Use Intention Score', 'timeFrame': 'Baseline (Week 0) and post-intervention (Week 8)', 'description': '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.\n\nMetric: 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.'}, {'measure': 'Inhibitory Control Performance', 'timeFrame': 'Baseline (Pre-intervention) and 8 weeks (Post-intervention)', 'description': '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).'}, {'measure': 'Substance Use and pshycosocial risk level', 'timeFrame': 'Baseline (Week 0) and post-intervention (Week 8)', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Absolute and relative power in Alpha and Theta bands', 'timeFrame': 'Baseline (Pre-intervention) and 8 weeks (Post-intervention)', 'description': '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.\n\nFrontal 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.'}, {'measure': 'Change in Emotional Dysregulation Level', 'timeFrame': 'Baseline (Week 0) and Week 8 (post-intervention)', 'description': "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)."}, {'measure': 'Life Skills Development', 'timeFrame': 'Baseline (Week 0) and post-intervention (Week 8)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Children,', 'Institutionalization', 'Life Skills Training'], 'conditions': ['Institutionalization']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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 CaliforniaNational 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.\n\nProblem Statement Research Question What are the psychological and neuropsychological effects of a life-skills-based intervention in institutionalized adolescents?\n\nSpecific Questions What is the effect of a Life Skills (LS) intervention on brain function organization?\n\nWhat is the effect of an LS-based intervention on social skills?\n\nWhat is the effect of a Life Skills intervention on inhibitory control?\n\nWhat is the effect of an LS-based intervention on emotional regulation?\n\nWhat effect do LS-based interventions generate on substance use intention?\n\nBackground 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.\n\nDuring 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.\n\nScientific 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.\n\nRegional 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.\n\nObjectives 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.\n\nSpecific Objectives Analyze changes in general neurocognitive functioning after the LS intervention.\n\nDetermine 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adolescents aged 12 to 17 who have lived in the participating children's home.\n* Ability to understand and respond to the tests and questionnaires administered during the study.\n* Approval and signature of the director or legal guardians of the social welfare institutions on the informed consent form.\n\nInformed consent of the adolescent.\n\nExclusion Criteria:\n\n* Adolescents diagnosed with externalizing disorders, intellectual disabilities, or severe or serious psychiatric disorders that prevent them from understanding the intervention protocol.\n* Adolescents who are undergoing administrative processes such as family reintegration or imminent relocation that make it difficult to complete the assessments.\n* Participation in other studies that interfere with the application of the assessment instruments.\n* Situations of acute emotional, medical, or behavioral crisis observed by the administrative staff of social welfare institutions."}, 'identificationModule': {'nctId': 'NCT07492069', 'acronym': 'CASA-HpV', 'briefTitle': 'Life Skills-Based Intervention on Substance Use Intention in Adolescents in Social Care Institutions', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Autonoma de Baja California'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'MP/2026/LIRU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Life Skills Training (LST)', 'description': '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.', 'interventionNames': ['Behavioral: Life Skills Training (LST)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Psychoeducation Traditional', 'description': '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.', 'interventionNames': ['Behavioral: Psicoeducation Traditional']}], 'interventions': [{'name': 'Life Skills Training (LST)', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Life Skills Training (LST)']}, {'name': 'Psicoeducation Traditional', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Psychoeducation Traditional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21720', 'city': 'Mexicali', 'state': 'Estado de Baja California', 'country': 'Mexico', 'facility': 'Universidad Autonoma de Baja California, Facultad de Ciencias Administrativas, sociales e ingenieria', 'geoPoint': {'lat': 32.62781, 'lon': -115.45446}}], 'centralContacts': [{'name': 'Ulises Alejandro Licea Rodriguez, Pshycologist', 'role': 'CONTACT', 'email': 'ulicea@uabc.edu.mx', 'phone': '+526861917559'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Autonoma de Baja California', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full time Research', 'investigatorFullName': 'Gilberto Galindo', 'investigatorAffiliation': 'Universidad Autonoma de Baja California'}}}}