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

NCT05281172 | Completed

• 1 other identifier: PID2019-110400RB-I00
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Abuse or Dependence

Outcome Measures

Primary Outcomes (3)

• Alcohol use change

  Alcohol use will be assessed using the Timeline Follow-Back (Sobell \& Sobell, 1992)

  Change from baseline up to 5 weeks and two follow-ups at 6 and 12 months post intervention

• Alcohol abuse

  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.

  Change from baseline to week 5, and at 6 and 12 months post intervention.

• Alcohol dependence

  Alcohol dependence will be assessed with the Alcohol Use Disorder and Associated Disabilities Interview Schedule-5 (Grant et al., 2015).

  Change from baseline to week 5, and at 6 and 12 months post intervention.

Secondary Outcomes (3)

• Drug use

  Change from baseline to week 5, and at 6 and 12 months post intervention.

• Impulsiveness

  Change from baseline to week 5, and at 6 and 12 months post intervention.

• Sleep quality

  Change from baseline to week 5, and at 6 and 12 months post intervention.

Study Arms (2)

Guided Self-Change therapy

EXPERIMENTAL

Behavioral: Guided Self-Change therapy (GSC)

Psychoeducation program about healthy habits

ACTIVE COMPARATOR

Behavioral: Psychoeducation program about healthy habits

Interventions

Guided Self-Change therapy (GSC) 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.

Guided Self-Change therapy

Psychoeducation program about healthy habits 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.

Psychoeducation program about healthy habits

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Ministry of Science and Innovation, Spain: collaborator

Study Sites (1)

José Luis Carballo

Elche, Alicante, 03203, Spain

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• José Luis Carballo, PhD

  Miguel Hernández University of Elche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Researcher

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: March 16, 2022
• Study Start: March 21, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 15, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)