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

Prevention of Alcohol Abuse in Educational Settings (PRVENALC)

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Abuse or Dependence
• Intervention / Treatment: Behavioral: Guided Self-Change therapy (GSC); Behavioral: Psychoeducation program about healthy habits

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03203
      • José Luis Carballo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided Self-Change therapy	Behavioral: 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.
Active Comparator: Psychoeducation program about healthy habits	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drug use	Assessed with the Drug History Questionnaire (Sobell et al., 1995).	Change from baseline to week 5, and at 6 and 12 months post intervention.
Impulsiveness	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.	Change from baseline to week 5, and at 6 and 12 months post intervention.
Sleep quality	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.	Change from baseline to week 5, and at 6 and 12 months post intervention.

Collaborators and Investigators

• Sponsor: Universidad Miguel Hernandez de Elche
• Collaborators: Spanish Ministry of Science, Innovation, and Universities
• Investigators: Principal Investigator: José Luis Carballo, PhD, Miguel Hernández University of Elche

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): May 1, 2024
• Study Completion (Actual): May 15, 2024

Study Registration Dates

• First Submitted: February 10, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: PID2019-110400RB-I00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No