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Completed

NCT Number: NCT05281172

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

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.

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Key information

Conditions

Alcohol Abuse or Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

16 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

José Luis Carballo

Elche, Alicante, 03203, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Alcohol use change

    Time frame: 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)

  2. Alcohol abuse

    Time frame: 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.

  3. Alcohol dependence

    Time frame: 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).

Secondary outcomes

  1. Drug use

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

    Assessed with the Drug History Questionnaire (Sobell et al., 1995).

  2. Impulsiveness

    Time frame: 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.

  3. Sleep quality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Miguel Hernandez de Elche

Other

Collaborators

  • Ministry of Science and Innovation, Spain

Registry information

Official study title

Prevention of Alcohol Abuse in Educational Settings (PRVENALC)

Acronym: PREVENALC

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2022
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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