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Guided Self-Change Prevention Program for Alcohol Abuse in Adolescents in Educational Settings

Prevention of Alcohol Abuse in Educational Settings (PRVENALC)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05281172
Acronym
PREVENALC
Enrollment
800
Registered
2022-03-16
Start date
2022-03-21
Completion date
2024-05-15
Last updated
2024-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Abuse or Dependence

Brief summary

This study corresponds to a pretest-posttest randomized experimental design with two arms. Arm 1 includes Guided Self-Change program, and Arm 2 a psychoeducational program to promote healthy habits. This study aims to analyze the efficacy of a selective and indicated prevention program based on the Guided Self-Change model (GSC) in adolescent alcohol users between 16-18 years. Researchers hypothesize that implementation of GSC therapy will lead to a greater reduction of alcohol drinkers compare with the control condition, and will prevent alcohol abuse after 6 and 12 months.

Interventions

BEHAVIORALGuided Self-Change therapy (GSC)

The GSC program follows a motivational cognitive-behavioral approach designed to minimize resistance in drug behavior changes, prevent relapse risk, and increase motivation to quit. The GSC consists of 5 weekly sessions of 50 minutes delivered in groups of 20-25 people.

BEHAVIORALPsychoeducation program about healthy habits

The psychoeducational program will include talks about healthy habits such as physical activity, relaxation, and sleep hygiene. This intervention consists of 5 weekly sessions of 50 minutes delivered in groups of 20-25 people.

Sponsors

Ministry of Science and Innovation, Spain
CollaboratorOTHER_GOV
Universidad Miguel Hernandez de Elche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* 16-18 years old. * Having inform consent from parents * Report using alcohol at least once a month during the previous last three months

Exclusion criteria

* Participants will be excluded if they refer being diagnosed with a severe mental disorder. * Have a severe medical illness that will limit participation * Being under treatment for a psychological of psychiatric problem. * Meet DSM criteria for Drug dependence to illegal drugs.

Design outcomes

Primary

MeasureTime frameDescription
Alcohol use changeChange from baseline up to 5 weeks and two follow-ups at 6 and 12 months post interventionAlcohol use will be assessed using the Timeline Follow-Back (Sobell & Sobell, 1992)
Alcohol abuseChange from baseline to week 5, and at 6 and 12 months post intervention.Alcohol abuse will be assessed using the Rutgers Alcohol Problem Index (White & Labouvie, 1989). The global score ranges from 0 to 69, where higher scores represent greater level of alcohol-related problems.
Alcohol dependenceChange from baseline to week 5, and at 6 and 12 months post intervention.Alcohol dependence will be assessed with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (Grant et al., 2015).

Secondary

MeasureTime frameDescription
Drug useChange from baseline to week 5, and at 6 and 12 months post intervention.Assessed with the Drug History Questionnaire (Sobell et al., 1995).
ImpulsivenessChange from baseline to week 5, and at 6 and 12 months post intervention.Impulsiveness will be assessed with the Impulsive Behavior Scale (Cyders et al., 2014). The global score ranges from 20 to 80, where higher scores represent greater level of impulsivity.
Sleep qualityChange from baseline to week 5, and at 6 and 12 months post intervention.Sleep will be assessed with different sleep measures, such as the Brief version of the Pittsburgh Sleep Quality Index (Sancho-Domingo et al., 2021). The global score of the B-PSQI ranges from 0 to 15, where higher scores represent poor sleep quality.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026