NCT05321238

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2020

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

22 days

First QC Date

April 1, 2022

Last Update Submit

April 14, 2022

Conditions

Keywords

agencyfear appealalcoholnarrative

Outcome Measures

Primary Outcomes (2)

  • Perceived self-efficacy

    Three items answered on 7-point Likert scales (ranging from 'Strongly Disagree' to 'Strongly Agree'): 1. I am able to limit my alcohol intake to low amounts. 2. It is easy for me to limit my alcohol intake to low amounts. 3. I can limit my alcohol intake to low amounts.

    During the lab session

  • Behavioural intention

    Four items answered on 7-point Likert scales (ranging from 'Strongly Disagree' to 'Strongly Agree'): 1. I intend to limit my alcohol intake to low amounts. 2. I intend to limit my alcohol intake to low amounts on special occasions. 3. I intend to limit my alcohol intake to low amounts when being with friends. 4. I intend to limit my alcohol intake to low amounts when I am by myself.

    During the lab session

Other Outcomes (7)

  • Perceived Agency

    During the lab session

  • Fear

    During the lab session

  • Perceived Severity, Susceptability and Response-Efficacy

    During the lab session

  • +4 more other outcomes

Study Arms (4)

High agency and immediate threat

EXPERIMENTAL

Participants were asked to make decisions within the interactive digital narrative and were presented with acute alcohol poisoning of the main character in the story.

Other: High agency and immediate threat

High agency and distant threat

EXPERIMENTAL

Participants were asked to make decisions within the interactive digital narrative and were presented with multiple organ failure after years of alcohol consumption of the main character in the story.

Other: High agency and distant threat

Low agency and immediate threat

EXPERIMENTAL

Participants were presented with a fixed (passive) narrative without decisions and were presented with acute alcohol poisoning of the main character in the story.

Other: Low agency and immediate threat

Low agency and distant threat

EXPERIMENTAL

Participants were presented with a fixed (passive) narrative without decisions and were presented with multiple organ failure after years of alcohol consumption of the main character in the story.

Other: Low agency and distant threat

Interventions

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 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 multiple organ failure after ingesting too much alcohol over a long period of time.

High 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 acute alcohol poisoning after ingesting too much alcohol in a short 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 multiple organ failure after ingesting too much alcohol over a long period of time.

Low agency and distant threat

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • above 18 years of age
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tilburg University

Tilburg, North Brabant, 5037AB, Netherlands

Location

Related Publications (1)

  • Engelbrecht H, van der Laan LN, van Enschot R, Krahmer E. The Role of Agency and Threat Immediacy in Interactive Digital Narrative Fear Appeals for the Prevention of Excessive Alcohol Use: Randomized Controlled Trial. JMIR Serious Games. 2022 Jun 13;10(2):e32218. doi: 10.2196/32218.

MeSH Terms

Conditions

Narration

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Hendrik Engelbrecht

    Tilburg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were not aware which arm of the study they were enrolled in.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2022

First Posted

April 11, 2022

Study Start

November 26, 2020

Primary Completion

December 18, 2020

Study Completion

December 18, 2020

Last Updated

April 22, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations