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OpenTrials
Completed

NCT Number: NCT04699955

Longitudinal Use of Protective Behavioral Strategies

This study tested a deviance regulation theory intervention in a sample of university freshman. The aims were to (a) increase use of protective behavioral strategies, (b) decrease alcohol use, and (c) decrease alcohol-related consequences.

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Key information

Age range

18 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of central Florida

Orlando, Florida, 32816-0001, United States

About this study

College student freshmen were invited to participate in a study on the use of alcohol protective behavioral strategies. They were randomly assigned to receive a positive message about individuals that used protective strategies, a negative message about individuals that did not use protective strategies, or an assessment control. They were then followed for the next 12 months. Assessments were completed at weeks 0, 1, 2, 3, 4, 5, 12, 26, and 52.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • College freshman at UCF
  • Endorse alcohol consumption in the past two weeks

Exclusion criteria

  • Severe mental illness
  • Under 18 years of age
  • Over 21 years of age
  • Unable to speak English fluently

Treatment and study plan

Deviance Regulation Theory

Behavioral

In the negative message condition, participants received information on the negative aspects of individuals that did not used protective strategies and were encouraged to report why these individuals were viewed so much more negatively. In the positive message condition, participants received information on the positive aspects of individuals that used protective strategies and were encouraged to report why these individuals were viewed so much more positively.

Primary outcomes

  1. Protective Behavioral Strategies- Pre-Intervention

    Time frame: Past three months prior to intervention/study

    Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times).

    These PBS were assessed in this study using Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past three months.

  2. Protective Behavioral Strategies- Initial intervention (Week 1)

    Time frame: Past week before intervention

    Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times).

    These PBS were assessed in this study using Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.

  3. Protective Behavioral Strategies- Week 2

    Time frame: Past 1 week measured- 1 week post intervention

    Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times).

    These PBS were assessed in this study using Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.

  4. Protective Behavioral Strategies- Week 3

    Time frame: Past 1 week measured-2 weeks post intervention

    Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times).

    These PBS were assessed in this study using Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.

  5. Protective Behavioral Strategies- Week 4

    Time frame: Past 1 week measured-3 weeks post intervention

    Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times).

    These PBS were assessed in this study using Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.

  6. Protective Behavioral Strategies- Week 5

    Time frame: Past 1 week measured-4 weeks post intervention

    Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times).

    These PBS were assessed in this study using Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.

  7. Protective Behavioral Strategies- Week 6

    Time frame: Past 1 week measured-5 weeks post intervention

    Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times).

    These PBS were assessed in this study using Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past week.

  8. Protective Behavioral Strategies- 3 month follow up

    Time frame: Past 3 months measured- 12 week post intervention

    Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times).

    These PBS were assessed in this study using Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past three months.

  9. Protective Behavioral Strategies- 6 month follow-up

    Time frame: Past 3 months measured- 26 weeks post intervention

    Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times).

    These PBS were assessed in this study using Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past three months.

  10. Protective Behavioral Strategies- 12 month follow-up

    Time frame: Past 3 months measured- 52 weeks post intervention

    Protective behavioral strategies (PBS) are a collection of harm-reduction strategies aimed to decrease alcohol-related consequences when consuming alcohol. The are three broad subtypes of PBS: (1) Manner of Drinking (MD; e.g., avoiding mixing different types of alcohol), (2) Stopping/Limiting Drinking (SLD; e.g., stopping drinking at a predetermined time), and (3) Serious Harm Reduction (SHR; e.g., knowing where your drink is at all times).

    These PBS were assessed in this study using Protective Behavioral Strategies Survey-20 (PBS-20). The PBS-20 consists of 20 statements covering three factors of protective strategies: Manner of Drinking, Stopping/Limiting Drinking, and Serious Harm Reduction. The frequency of PBS use was be reported on a five-point Likert-scale from 'Never' to 'Always'. Participants were asked to record their PBS use from the past three months.

Secondary outcomes

  1. Alcohol-related consequences- Pre-intervention

    Time frame: Past three months prior to intervention/study

    Alcohol-related consequences was assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past three months.

  2. Alcohol-related consequences- Initial intervention (Week 1)

    Time frame: Past week before intervention

    Alcohol-related consequences was assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.

  3. Alcohol-related consequences- Week 2

    Time frame: Past 1 week measured- 1 week post intervention

    Alcohol-related consequences was assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.

  4. Alcohol-related consequences- Week 3

    Time frame: Past 1 week measured- 2 week post intervention

    Alcohol-related consequences was assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.

  5. Alcohol-related consequences- Week 4

    Time frame: Past 1 week measured- 3 week post intervention

    Alcohol-related consequences was assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.

  6. Alcohol-related consequences- Week 5

    Time frame: Past 1 week measured- 4 week post intervention

    Alcohol-related consequences was assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.

  7. Alcohol-related consequences- Week 6

    Time frame: Past 1 week measured- 5 week post intervention

    Alcohol-related consequences was assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past week.

  8. Alcohol-related consequences- 3 month follow up

    Time frame: Past 3 months measured- 12 week post intervention

    Alcohol-related consequences was assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past three months.

  9. Alcohol-related consequences- 6 month follow-up

    Time frame: Past 3 months measured- 26 weeks post intervention

    Alcohol-related consequences was assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past three months.

  10. Alcohol-related consequences- 12 month follow-up

    Time frame: Past 3 months measured- 52 weeks post intervention

    Alcohol-related consequences was assessed using the Young Adult Alcohol Consequences Questionnaire (YAACQ), which consists of 48 items assessing eight categories of alcohol-related consequences: Social-Interpersonal, Impaired Control, Self-Perception, Self-Care, Risk Behaviors, Academic/Occupational, Physical Dependence, and Blackout Drinking. Participants recorded alcohol consequences (Yes/No/ I do not wish to respond) from the past three months.

  11. Alcohol use- Pre-intervention

    Time frame: Past three months prior to intervention/study

    Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure average alcohol consumption and time spent drinking during a typical week over the past three months. The DDQ-M is composed of a free-text grid where individuals report the number of drinks typically consumed for each day of the week for the past three months.

  12. Alcohol use- Initial intervention (Week 1)

    Time frame: Past week before intervention

    Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.

  13. Alcohol use- Week 2

    Time frame: Past 1 week measured- 1 week post intervention

    Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.

  14. Alcohol use- Week 3

    Time frame: Past 1 week measured- 2 weeks post intervention

    Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.

  15. Alcohol use- Week 4

    Time frame: Past 1 week measured- 3 weeks post intervention

    Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.

  16. Alcohol use- Week 5

    Time frame: Past 1 week measured- 4 weeks post intervention

    Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.

  17. Alcohol use- Week 6

    Time frame: Past 1 week measured- 5 weeks post intervention

    Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure the number of drinks consumed for each day of the past week. Each grid began with Monday and ended with Sunday, as surveys were sent out on Mondays.

  18. Alcohol use- 3 month follow up

    Time frame: Past 3 months measured- 12 week post intervention

    Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure average alcohol consumption and time spent drinking during a typical week over the past three months. The DDQ-M is composed of a free-text grid where individuals report the number of drinks typically consumed for each day of the week for the past three months.

  19. Alcohol use- 6 month follow up

    Time frame: Past 3 months measured- 24 week post intervention

    Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure average alcohol consumption and time spent drinking during a typical week over the past three months. The DDQ-M is composed of a free-text grid where individuals report the number of drinks typically consumed for each day of the week for the past three months.

  20. Alcohol use- 12 month follow up

    Time frame: Past 3 months measured- 52 week post intervention

    Alcohol use (quantity) was assessed using the Modified Daily Drinking Questionnaire (DDQ-M). The DDQ-M was used to measure average alcohol consumption and time spent drinking during a typical week over the past three months. The DDQ-M is composed of a free-text grid where individuals report the number of drinks typically consumed for each day of the week for the past three months.

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 7, 2021
Registry last updated
Jan 7, 2021

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