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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05321238
Other study ID # 2020.141
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 26, 2020
Est. completion date December 18, 2020

Study information

Verified date April 2022
Source Tilburg University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Aims: The first aim of the study was to assess the effect of agency, i.e. the perception of making meaningful decisions, in an interactive digital narrative fear appeal on self-efficacy beliefs concerning the ability to reduce alcohol intake among college students. Second, we assessed whether the communicated timeframe (short-term / long-term) of the threat presented in the narrative moderates the effect of agency on self-efficacy. Lastly, to validate the effect of the intervention on behavioural outcomes we assesed whether self-efficacy has an effect on behavioural intention measures. The study was a 2 (agency: low / high) x 2 (time-frame: immediate / distant) between-subjects online experiment.


Recruitment information / eligibility

Status Completed
Enrollment 178
Est. completion date December 18, 2020
Est. primary completion date December 18, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - above 18 years of age - 480 seconds survey completion time - both attention checks relating to narrative content passed - correctly identified their experimental condition in the manipulation check - did not choose to 'drink an alcoholic drink' for all decisions in the interactive narrative - did not show signs of alcohol abuse Exclusion Criteria: - under the age of 18 - completed the questionnaire in an unreasonably short amount of time - they failed one of the two attention checks - failed the manipulation check asking them to recall whether they were presented with short- or long-term (high / low immediacy) consequences of excessive drinking - chose an alcoholic drink for all decision points - showed signs of alcohol dependence as measured above 15 on the Brief Young Adult Alcohol Consequences Questionnaire (B-YAACQ)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
High agency and immediate threat
Participants were asked to make several decisions for the main character in the interactive digital narrative that related to drinking / turning down alcoholic drinks.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from acute alcohol poisoning after ingesting too much alcohol in a short period of time.
High agency and distant threat
Participants were asked to make several decisions for the main character in the interactive digital narrative that related to drinking / turning down alcoholic drinks.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from multiple organ failure after ingesting too much alcohol over a long period of time.
Low agency and immediate threat
Participants were asked to read a narrative in which the main character turns down alcoholic drinks at a party. The participants can not influence the decisions of the main character and only consume the narrative passively.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from acute alcohol poisoning after ingesting too much alcohol in a short period of time.
Low agency and distant threat
Participants were asked to read a narrative in which the main character turns down alcoholic drinks at a party. The participants can not influence the decisions of the main character and only consume the narrative passively.The decisions made lead to a ending consistent with the decisions of the participant. In the story presented, a character dies from multiple organ failure after ingesting too much alcohol over a long period of time.

Locations

Country Name City State
Netherlands Tilburg University Tilburg Noord Brabant

Sponsors (1)

Lead Sponsor Collaborator
Tilburg University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Other Perceived Agency Five items Items were measured on 7-point Likert scales from 'Strongly Disagree' to 'Strongly Agree'. For example, 'I felt that the actions I took were meaningful within the context of the story'. During the lab session
Other Fear Six items were scored on 7-point Likert scales from 'Not at all' to 'Very much'. The items ask participants about the intensity of affective response towards the message, for example, 'How much did this message make you feel frightened?'. During the lab session
Other Perceived Severity, Susceptability and Response-Efficacy Severity, susceptibility and response-efficacy items were measured with three items each on 7-point Likert scales from 'Strongly Disagree' to 'Strongly Agree'. During the lab session
Other Symptoms of Alcohol Abuse We measured the consequences of alcohol related behavior indicating dependence. One example of an item is 'My drinking has gotten me into sexual situations I later regretted.'. The brief young adult alcohol consequences questionnaire (BYAACQ) consists of 24 statements that are scored with binary yes / no answers. A score above 15 positive answers indicates alcohol dependence. The scale was developed by (Kahler et al., 2008). During the lab session
Other Drinking Frequency Frequency was measured by asking participants how often they 'drink alcohol in excess' and was measured on a 7-point Likert scale ranging from 'Never' to 'Very Frequently'. During the lab session
Other Perceived Control Perceived control was measured by two items asking participants whether or not they can 'control' and 'stop' drinking alcohol whenever they want. These two items were measured on 7-point Likert scales ranging from 'Strongly Disagree' to 'Strongly Agree'. During the lab session
Other Behavioural inhibition The items to measures disinhibition were taken over unchanged from the scale by Lee & Shinn (2011), but altered from 9-point to 7-point Likert scales ranging from 'Strongly Disagree' to 'Strongly Agree'. During the lab session
Primary Perceived self-efficacy Three items answered on 7-point Likert scales (ranging from 'Strongly Disagree' to 'Strongly Agree'):
I am able to limit my alcohol intake to low amounts.
It is easy for me to limit my alcohol intake to low amounts.
I can limit my alcohol intake to low amounts.
During the lab session
Primary Behavioural intention Four items answered on 7-point Likert scales (ranging from 'Strongly Disagree' to 'Strongly Agree'):
I intend to limit my alcohol intake to low amounts.
I intend to limit my alcohol intake to low amounts on special occasions.
I intend to limit my alcohol intake to low amounts when being with friends.
I intend to limit my alcohol intake to low amounts when I am by myself.
During the lab session
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