Alcohol; Harmful Use Clinical Trial
Official title:
Brief Intervention Based on the Theory of Planned Behavior to Reduce Alcohol Consumption in University Students
NCT number | NCT05533554 |
Other study ID # | 117 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 23, 2022 |
Est. completion date | July 15, 2023 |
Verified date | August 2023 |
Source | Universidad Autónoma de Tamaulipas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 87 |
Est. completion date | July 15, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 29 Years |
Eligibility | Inclusion Criteria: - Be a university student in the first or second year. - Be between 18 and 29 years old. - Voluntarily participate in the study. Exclusion Criteria (post-hoc): - Presence of severe mental disorder (e.g., psychotic disorders). - Not having stable housing. |
Country | Name | City | State |
---|---|---|---|
Mexico | Universidad Autónoma de Tamaulipas | Victoria | Tamaulipas |
Lead Sponsor | Collaborator |
---|---|
Daniela Romero Reyes | Universidad Nacional de Educación a Distancia |
Mexico,
Ajzen I. Design and evaluation guided by the theory of planned behavior. Soc psychol Eval, Guilford Publications. 2011:74-100.
Ajzen I. The theory of planned behavior. Organizational behavior and human decision processes. 1991;50(2):179-211.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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).
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. — View Citation
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.
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Mean change in the assessment of the consequences of consumption (behavioral beliefs: attitude) measured through the TAP Questionnaire for alcohol consumption | Subscale made up of 25 items that evaluate attitude through consequences of consumption highly valued in the study population (behavioral beliefs), with 5 response options scored from 0 to 4 from "not important at all" to "very important". Lower scores indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it. | 4 weeks | |
Secondary | Mean change in subjective, personal and descriptive norms measured through the TAP Questionnaire for alcohol consumption | Subscale composed of 2 items of subjective norms and 1 item of descriptive norms, with 5 Likert-type response options scored from 0 to 4, lower scores indicate a positive response to the intervention. It also includes 1 personal norm item with 5 response options scored from 0 to 4; higher scores on this item indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it. | 4 weeks | |
Secondary | Mean change in perceived behavioral control measured through the TAP Questionnaire for alcohol consumption | Subscale composed of 2 items of perceived behavioral control towards alcohol consumption, scored from 0 to 4, lower scores on these items indicate a positive response to the intervention. The scale is also integrated by 3 items of perceived behavioral control towards alcohol abstinence, scored from 0 to 4, higher scores in these items indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it. | 4 weeks | |
Secondary | Mean change in the intention to consume alcohol measured through the TAP Questionnaire for alcohol consumption | Scale composed of 3 items of alcohol consumption intention with five response options from 0 to 4. Lower scores indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it. | 4 weeks | |
Secondary | Mean change in the degree of self-efficacy to face situations of alcohol consumption measured through the Brief Situational Confidence Questionnaire for university students | The objective of this scale is to measure the concept of self-efficacy in relation to the participant's perception of their ability to deal effectively with situations of alcohol consumption. The scale is made up of a single dimension of 4 items with response options from 0 (I do not trust myself) to 3 (I totally trust myself), the higher the score, the higher the self-efficacy. Higher scores on this scale indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it. | 4 weeks | |
Secondary | Measurement of adverse events through the implementation of the Scale on Consequences of Alcohol Consumption in University Students | This instrument measures consequences of alcohol consumption. It has 25 items with "yes/no" response options for the occurrence of consequences and for the frequency of occurrence of consequences in the last month: 0 times, 1 time, 2 times, 3 times, 4 to 5 times, 6 to 7 times, 12 to 20 months, more than 21 times. Fewer number and frequency of consequences indicate a positive response to the intervention. Participants will be asked to answer the instrument one day before the intervention and four weeks after it. | 4 weeks | |
Secondary | Help-seeking intention in young adults with hazardous and harmful alcohol consumption questionnaire (IH-RHAC) | instrument aims to measure help-seeking intention and attitude, subjective norm, and perceived behavioral control (operationalized as self-efficacy) based on the beliefs underlying these constructs: behavioral beliefs, normative beliefs, respectively, including the variable seeking help in the past. The scale is composed of five sections: (a) attitude, (b) subjective norm, (c) self-efficacy, (d) help-seeking intentions, and (e) past help-seeking. Responses were scored on a Likert-type scale from 1 to 5. Participants will be asked to answer the instrument one day before and one day after the intervention and four weeks after it. | 4 weeks |
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