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

Not Applicable

Completed

• Conditions: Alcohol Abuse or Dependence
• Interventions: Behavioral: Guided Self-Change therapy (GSC); Behavioral: Psychoeducation program about healthy habits

• Registration Number: NCT05281172
• Lead Sponsor: Universidad Miguel Hernandez de Elche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-03-10
• Study First Posted: 2022-03-16
• Study Start: 2022-03-21
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-27
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided Self-Change therapy	Guided Self-Change therapy (GSC)	-
Psychoeducation program about healthy habits	Psychoeducation program about healthy habits	-

Primary Outcome Measures

Name	Time	Method
Alcohol abuse	Change 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 dependence	Change 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).
Alcohol use change	Change from baseline up to 5 weeks and two follow-ups at 6 and 12 months post intervention	Alcohol use will be assessed using the Timeline Follow-Back (Sobell \& Sobell, 1992)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

José Luis Carballo; 🇪🇸 Elche, Alicante, Spain