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

NCT ID: NCT05281172

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2024-05-15

Brief Summary

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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.

Detailed Description

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Conditions

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Alcohol Abuse or Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Guided Self-Change therapy

Group Type EXPERIMENTAL

Guided Self-Change therapy (GSC)

Intervention Type BEHAVIORAL

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.

Psychoeducation program about healthy habits

Group Type ACTIVE_COMPARATOR

Psychoeducation program about healthy habits

Intervention Type BEHAVIORAL

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.

Interventions

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Guided 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.

Intervention Type BEHAVIORAL

Psychoeducation 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Science and Innovation, Spain

OTHER_GOV

Sponsor Role collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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Jose Luis Carballo Crespo, PhD

Associate Professor and Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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José Luis Carballo, PhD

Role: PRINCIPAL_INVESTIGATOR

Miguel Hernández University of Elche

Locations

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José Luis Carballo

Elche, Alicante, Spain

Site Status

Countries

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Spain

Other Identifiers

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PID2019-110400RB-I00

Identifier Type: -

Identifier Source: org_study_id

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