Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students

NCT05533554 | Completed DMC

• 1 other identifier: 117
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Brief behavioral intervention designed from the guidelines of the Theory of Planned Action (TAP) of Ajzen (1991). It has the general objective of reducing the intention and hazardous and harmful consumption of alcohol in young university students in the first year of their undergraduate degree. The following specific objectives are considered: (a) Impact on the personal and descriptive norm by modifying the perception of the actual use of alcohol and its level of acceptance among the population of university students. (b) Modify attitudes towards consumption by reducing the value attributed to the expectations associated with risky alcohol consumption. (c) Increase perceived behavioral control and self-efficacy to avoid alcohol consumption behavior by: establishing a goal, consumption planning, and increase assertive communication.(d) Reduce the negative consequences of the use of alcohol in different situations of young people through pleasant healthy activities. e) Increase the intention to seek help for alcohol-related problems.The intervention will be developed through 3 phases. The first phase corresponds to the pre-intervention evaluation, the second phase concerns the two intervention sessions and the third phase is the post-intervention evaluation. Hypothesis: The mean alcohol consumption will be lower in young adults with hazardous and harmful alcohol consumption in the experimental group who received a brief online intervention compared to the control group.

Conditions

Alcohol; Harmful Use

Keywords

Brief online intervention; Planned Behavior Theory; Hazardous and harmful use of alcohol; University Students

Outcome Measures

Primary Outcomes (2)

• Mean change in score on the Alcohol Use Disorders Identification Questionnaire - Concise (AUDIT-C)

  The AUDIT-C has 3 questions and is scored on a scale of 0 to 12. Each AUDIT-C question has 5 response options valued from 0 points to 4 points. Lower scores indicate a positive response to the intervention. The instrument will be applied in the preevaluation and up to four weeks after the end of the intervention.

  4 weeks

• Mean change in the amount of standard drinks ingested evaluated with the LIBARE Retrospective Baseline, from the initial evaluation, in two intra-sessions and two weeks after the end of the intervention

  Instrument in the form of a calendar where the participant will be asked to record the days of consumption and the amount consumed according to the standard drink measure in a period of three months prior to the intervention. Afterwards, four weeks post-intervention, the participant will be asked to fill out this calendar for the 30 days that have elapsed since the last session. Fewer days of consumption, less number of drinks per consumption occasion and number of standard drinks ingested indicate a positive response to the intervention.

  4 weeks

Secondary Outcomes (7)

• Mean change in the assessment of the consequences of consumption (behavioral beliefs: attitude) measured through the TAP Questionnaire for alcohol consumption

  4 weeks

• Mean change in subjective, personal and descriptive norms measured through the TAP Questionnaire for alcohol consumption

  4 weeks

• Mean change in perceived behavioral control measured through the TAP Questionnaire for alcohol consumption

  4 weeks

• Mean change in the intention to consume alcohol measured through the TAP Questionnaire for alcohol consumption

  4 weeks

• Mean change in the degree of self-efficacy to face situations of alcohol consumption measured through the Brief Situational Confidence Questionnaire for university students

  4 weeks

Study Arms (2)

Experimental group with intervention

EXPERIMENTAL

The experimental group will receive the intervention. First, the group will undergo a pre-intervention evaluation lasting 120 minutes. The intervention will consist of two synchronized virtual sessions of brief intervention with a cognitive-behavioral approach where various persuasive communication strategies will be implemented, definition of hazardous alcohol consumption, establishment of a consumption goal, social skills to deal with pressure to consume and plan of pleasant activities alternative to consumption, each session will last 120 minutes. Four weeks after the end of the intervention, the experimental group will carry out the post-intervention evaluation session in a virtual synchronized manner with a duration of 120 minutes.

Behavioral: Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students

Control group

NO INTERVENTION

The control group will participate in a pre-intervention evaluation session. Four weeks after the end of the last intra-session evaluation session, the control group will participate in the post-intervention evaluation in a virtual synchronized manner with a duration of 120 minutes.

Interventions

Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students BEHAVIORAL

Cognitive-behavioral intervention where the key concepts of the Theory of Planned Behavior were operationalized from which two intervention sessions were formed and the most appropriate techniques were chosen to influence the key concepts of the theory: behavioral beliefs, subjective norms, perceived behavioral control and self-efficacy. The program is made up of 3 evaluation sessions (pre and post a month later) and 2 intervention sessions with a duration of 120 minutes each.

Experimental group with intervention

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be a university student in the first or second year.
• Be between 18 and 29 years old.
• Voluntarily participate in the study.

You may not qualify if:

• Presence of severe mental disorder (e.g., psychotic disorders).
• Not having stable housing.

Sponsors & Collaborators

• Daniela Romero Reyes: lead
• Universidad Nacional de Educación a Distancia: collaborator

Study Sites (1)

Universidad Autónoma de Tamaulipas

Victoria, Tamaulipas, 87000, Mexico

Location

Related Publications (12)

• Ajzen I. The theory of planned behavior. Organizational behavior and human decision processes. 1991;50(2):179-211.

  BACKGROUND

• Davoren MP, Demant J, Shiely F, Perry IJ. Alcohol consumption among university students in Ireland and the United Kingdom from 2002 to 2014: a systematic review. BMC Public Health. 2016 Feb 19;16:173. doi: 10.1186/s12889-016-2843-1.

  PMID: 26895824 BACKGROUND

• Krieger H, Young CM, Anthenien AM, Neighbors C. The Epidemiology of Binge Drinking Among College-Age Individuals in the United States. Alcohol Res. 2018;39(1):23-30. doi: 10.35946/arcr.v39.1.05.

  PMID: 30557145 BACKGROUND

• Yi S, Ngin C, Peltzer K, Pengpid S. Health and behavioral factors associated with binge drinking among university students in nine ASEAN countries. Subst Abuse Treat Prev Policy. 2017 Jun 26;12(1):32. doi: 10.1186/s13011-017-0117-2.

  PMID: 28651601 BACKGROUND

• Bhochhibhoya A, Hayes L, Branscum P, Taylor L. The Use of the Internet for Prevention of Binge Drinking Among the College Population: A Systematic Review of Evidence. Alcohol Alcohol. 2015 Sep;50(5):526-35. doi: 10.1093/alcalc/agv047. Epub 2015 Jun 4.

  PMID: 26047832 BACKGROUND

• Mota R, Fuentes-Mejía C, Belchior M, Pinto G, León F, Cruvinel E. Brief interventions for substance abuse in Latin America: a systematic review. Psychology in Study. 2019;(24).

  BACKGROUND

• Tebb KP, Erenrich RK, Jasik CB, Berna MS, Lester JC, Ozer EM. Use of theory in computer-based interventions to reduce alcohol use among adolescents and young adults: a systematic review. BMC Public Health. 2016 Jun 17;16:517. doi: 10.1186/s12889-016-3183-x.

  PMID: 27317330 BACKGROUND

• Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399-418. doi: 10.1146/annurev.publhealth.012809.103604.

  PMID: 20070207 BACKGROUND

• Norman P, Cameron D, Epton T, Webb TL, Harris PR, Millings A, Sheeran P. A randomized controlled trial of a brief online intervention to reduce alcohol consumption in new university students: Combining self-affirmation, theory of planned behaviour messages, and implementation intentions. Br J Health Psychol. 2018 Feb;23(1):108-127. doi: 10.1111/bjhp.12277. Epub 2017 Sep 20.

  PMID: 28941040 BACKGROUND

• Ajzen I. Design and evaluation guided by the theory of planned behavior. Soc psychol Eval, Guilford Publications. 2011:74-100.

  BACKGROUND

• Hurlbut SC, Sher KJ. Assessing alcohol problems in college students. J Am Coll Health. 1992 Sep;41(2):49-58. doi: 10.1080/07448481.1992.10392818.

  PMID: 1460173 BACKGROUND

• Salazar GM, Muro MD, Udave MA, Leos FM. Adaptation of the Young Adult Alcohol Problem Screening Test (YAAPST) with university students from Mexico. Research and science. 2012;20(56):44-52.

  BACKGROUND

Related Links

• World Health Organization. (2018) Report of the WHO Independent High-Level Commission on Noncommunicable Diseases. Geneva, Switzerland.
• Chamber of Deputies of the H. Congress of the Union. (2022, May 16) General Health Law. Official Journal of the Federation.
• Ministry of Health (2009). Mexican Official Standard NOM-028-SSA2-2009 For the prevention, treatment and control of addictions.
• World Health Organization (2005). Document of the Americas on Good Clinical Practices. Pan American Health Organization.
• World Medical Association (2013). Declaration of Helsinki.
• World Health Organization. (2010) Global strategy to reduce the harmful use of alcohol. Geneva, Switzerland

MeSH Terms

Interventions

Ethanol; Economics

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Health Care Economics and Organizations

Study Officials

• Daniela Romero Reyes, Psychology

  Universidad Autónoma de Tamaulipas

  PRINCIPAL INVESTIGATOR

• Juan Antonio Moriano León, Psychology

  Universidad Nacional de Educación a Distancia

  STUDY DIRECTOR

• José Luis Ybarra Sagarduy, Psychology

  Universidad Autónoma de Tamaulipas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Simple, dynamic randomization will be carried out, balancing the groups based on sex (Female/Male). The masking will be single blind, where the researcher will know which participants will make up each group, said information will not be known to the participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Experimental methodology with experimental group and control group on waiting list.

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 9, 2022
• Study Start: September 23, 2022
• Primary Completion: June 30, 2023
• Study Completion: July 15, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 5 years
• Access Criteria: Previous request to Daniela Romero Reyes (danielaromeroreyes@gmail.com)

Locations

ME (1)