Interactive Alcohol Decision-Making Programs

Study Overview
=================
Brief Summary
-----------------
This project aims to develop a maximally effective, computer-delivered brief intervention (CDBI) for reducing heavy alcohol use. More specifically, the investigators will examine outcomes of different versions of a CDBI in which the presence/absence of empathic statements, the gender of the narrator, the presence/absence of a narrator backstory, and the use/non-use of motivational interviewing techniques are systematically manipulated using a factorial design. Participants (352 heavy drinkers) will be randomly assigned to 1 of 16 intervention conditions, representing all combinations of the 4 variables being manipulated. The investigators hypothesize that there will be significant main effects of all four factors being manipulated on (a) subjective reactions to the CDBI and (b) alcohol outcomes at 1-month follow-up

Detailed Description
-----------------
The National Survey on Drug Use and Health estimates that 19.3 million individuals ages 12 and over met criteria for an alcohol use disorder in the past year, fully 87.4% of whom neither received any treatment in the past 12 months, nor wanted it. Recognition of this tremendous gap has led to efforts, both nationally and internationally, to implement proactive screening and brief intervention. Brief interventions have proven efficacious in reducing unhealthy drinking with effect sizes in meta-analyses ranging from small to moderate. Brief interventions are also uniquely applicable to non-treatment-seeking populations, who may refuse extended treatment but accept a minimal, opportunistic intervention. However, the public health impact of brief interventions has been limited by substantial difficulty with implementation. Further, positive overall findings in meta-analyses obscure the results of multiple rigorous efficacy trials showing no brief intervention effect on alcohol use. Both of these issues-the implementation challenges and the inconsistency in outcomes-suggest that changes are needed before brief alcohol interventions can meet their full potential. Technology offers exciting potential in both respects. First, computer-delivered brief interventions (CDBIs) can be presented inexpensively, with perfect fidelity, and without the need for training or provider time. Second, their replicability, flexibility, and modularity makes them the perfect platform for (a) isolating the active ingredients that are associated with positive outcomes; and thereby (b) continually optimizing CDBIs to achieve cumulative increases in efficacy. The overall goal of this research is to develop a maximally effective and replicable CDBI for reducing heavy alcohol use. To accomplish this, the investigators will use the Multiphase Optimization Strategy (MOST), an efficient method for optimizing intervention content that uses factorial designs to evaluate main and interaction effects of specific intervention components. The selection of components will be guided by: (a) Common Factors Theory, which highlights the tremendous contribution of relational factors, such as empathy, alliance and positive regard to therapy outcomes, but which is of unknown relevance to CDBIs; and (b) the Media Equation Theory, which suggests that people automatically respond to computers in social ways, particularly when those computers replicate human characteristics. Guided by this literature, the investigators will examine outcomes of a CDBI in which empathic statements, the gender of the narrator, the presence/absence of a narrator backstory, and the use/non-use of motivational interviewing techniques are systematically manipulated using a factorial design. Specific aims are as follows: Develop 16 distinct, time-consistent, computer-delivered sessions representing all possible combinations of the following four factors (each of which will be binary; i.e. either present vs. absent or male vs. female): (1) narrator gender, (2) empathic statements and reflections, (3) narrator backstory, and (4) use of motivational techniques. Evaluate main and interaction effects of the five factors by randomly assigning 352 heavy drinkers to the 16 sessions (each of the four factors being presented to half of the participants) and evaluating (1) subjective reactions to the CDBI at baseline and (2) alcohol use at 1-month follow-up. Hypothesis 1. Subjective reactions to the CDBI, disclosure of alcohol use and consequences, and motivation to reduce alcohol use will be higher and alcohol use at follow-up will be lower in the presence of (1) empathic statements, (2) a narrator backstory and (3) motivational techniques. The effects of narrator gender will be examined in an exploratory way (i.e., no a priori hypotheses). Hypothesis 2. Subjective reactions will be more positive, disclosure and motivation to reduce alcohol use will be higher, and alcohol use at follow-up will be lower when the two relational factors (empathy and narrator backstory) are combined with the presence of motivational content.

Official Title
-----------------
Testing the Efficacy of Interactive Alcohol Decision-Making Program

Conditions
-----------------
Heavy Drinking

Intervention / Treatment
-----------------
* Behavioral: Empathic Statements/Reflections
* Behavioral: Narrator Backstory
* Behavioral: Male Narrator
* Behavioral: Female Narrator
* Behavioral: MI Techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over age 18 Access to the internet. Males must consume at least 14 drinks per week or 4 drinks per day Females must consume at least 7 drinks per week or 3 drinks per day Exclusion Criteria: Under age 18 No internet access Males who consume less than 14 drinks per week or 4 drinks per day Females who consume less than 7 drinks per week or 3 drinks per day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Four intervention components will be manipulated in a full factorial design, such that each participant either does or does not receive each intervention component.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Empathic Statements, MI, Male, No Backstory<br>Presence of empathic statements and MI techniques. Male narrator. No narrator backstory. | Behavioral: Empathic Statements/Reflections<br>* Presence of Empathic Statements<br>Behavioral: Male Narrator<br>* Presence of a male narrator<br>Behavioral: MI Techniques<br>* Presence of MI techniques<br>|
| Experimental: No Empathic Statements, No MI, Female, No Backstory<br>No empathic statements, MI techniques or narrator backstory. Female narrator | Behavioral: Female Narrator<br>* Presence of a female narrator<br>|
| Experimental: No Empathic Statements, No MI, Female, Backstory<br>No empathic statements or MI techniques. Presence of narrator backstory. Female narrator | Behavioral: Narrator Backstory<br>* Presence of a narrator backstory<br>Behavioral: Female Narrator<br>* Presence of a female narrator<br>|
| Experimental: Empathic Statements, MI, Female, Backstory<br>Presence of empathic statements, MI techniques and narrator backstory. Female narrator | Behavioral: Empathic Statements/Reflections<br>* Presence of Empathic Statements<br>Behavioral: Narrator Backstory<br>* Presence of a narrator backstory<br>Behavioral: Female Narrator<br>* Presence of a female narrator<br>Behavioral: MI Techniques<br>* Presence of MI techniques<br>|
| Experimental: No Empathic Statements, No MI, Male, No Backstory<br>No empathic statements, MI techniques or narrator backstory. Male narrator | Behavioral: Male Narrator<br>* Presence of a male narrator<br>|
| Experimental: Empathic Statements, MI, Male, Backstory<br>Presence of empathic statements, MI techniques and narrator backstory. Male narrator. | Behavioral: Empathic Statements/Reflections<br>* Presence of Empathic Statements<br>Behavioral: Narrator Backstory<br>* Presence of a narrator backstory<br>Behavioral: Male Narrator<br>* Presence of a male narrator<br>Behavioral: MI Techniques<br>* Presence of MI techniques<br>|
| Experimental: No Empathic Statements, MI, Female, Backstory<br>Presence of MI techniques and narrator backstory. No empathic statements. Female narrator. | Behavioral: Narrator Backstory<br>* Presence of a narrator backstory<br>Behavioral: Female Narrator<br>* Presence of a female narrator<br>Behavioral: MI Techniques<br>* Presence of MI techniques<br>|
| Experimental: Empathic Statements, No MI, Male, No Backstory<br>Presence of empathic statements. No MI techniques or narrator backstory. Male narrator. | Behavioral: Empathic Statements/Reflections<br>* Presence of Empathic Statements<br>Behavioral: Male Narrator<br>* Presence of a male narrator<br>|
| Experimental: No Empathic Statements, MI, Male, Backstory<br>Presence of MI techniques and narrator backstory. No empathic statements. Male narrator. | Behavioral: Narrator Backstory<br>* Presence of a narrator backstory<br>Behavioral: Male Narrator<br>* Presence of a male narrator<br>Behavioral: MI Techniques<br>* Presence of MI techniques<br>|
| Experimental: Empathic Statements, No MI, Female, No Backstory<br>Presence of empathic statements. No MI techniques or narrator backstory. Female narrator. | Behavioral: Empathic Statements/Reflections<br>* Presence of Empathic Statements<br>Behavioral: Female Narrator<br>* Presence of a female narrator<br>|
| Experimental: Empathic Statements, MI, Female, No Backstory<br>Presence of empathic statements and MI techniques. Female narrator. No narrator backstory. | Behavioral: Empathic Statements/Reflections<br>* Presence of Empathic Statements<br>Behavioral: Female Narrator<br>* Presence of a female narrator<br>Behavioral: MI Techniques<br>* Presence of MI techniques<br>|
| Experimental: No Empathic Statements, No MI, Male, Backstory<br>Presence of narrator backstory. No empathic statements or MI techniques. Male narrator. | Behavioral: Narrator Backstory<br>* Presence of a narrator backstory<br>Behavioral: Male Narrator<br>* Presence of a male narrator<br>|
| Experimental: Empathic Statements, No MI, Female, Backstory<br>Presence of empathic statements and narrator backstory. No MI techniques. Female narrator. | Behavioral: Empathic Statements/Reflections<br>* Presence of Empathic Statements<br>Behavioral: Narrator Backstory<br>* Presence of a narrator backstory<br>Behavioral: Female Narrator<br>* Presence of a female narrator<br>|
| Experimental: Empathic Statements, No MI, Male, Backstory<br>Presence of empathic statements and narrator backstory. No MI techniques. Male narrator. | Behavioral: Empathic Statements/Reflections<br>* Presence of Empathic Statements<br>Behavioral: Narrator Backstory<br>* Presence of a narrator backstory<br>Behavioral: Male Narrator<br>* Presence of a male narrator<br>|
| Experimental: No Empathic Statements, MI, Female, No Backstory<br>Presence of MI techniques. No empathic statements or narrator backstory. Female narrator. | Behavioral: Female Narrator<br>* Presence of a female narrator<br>Behavioral: MI Techniques<br>* Presence of MI techniques<br>|
| Experimental: No Empathic Statements, MI, Male, No Backstory<br>Presence of MI techniques. No empathic statements or narrator backstory. Male narrator. | Behavioral: Male Narrator<br>* Presence of a male narrator<br>Behavioral: MI Techniques<br>* Presence of MI techniques<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quantity and Frequency of Alcohol Use | The Timeline Followback Questionnaire (TLFB) will be given to assess past month alcohol use. | Given pre-intervention and at 1-month follow-up | 
| Change in Alcohol-Related Consequences | Assessed with the Brief Young Adult Alcohol Consequences Questionnaire which assess the occurrence/ non-occurrence of 24 alcohol consequences. | Given pre-intervention and at 1-month follow-up | 
| Participant Satisfaction with the Intervention | Fifteen item measure assessing how much participants liked the intervention and felt respected by it. | Given immediately after completing the intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol, Common Factors, Motivational Interviewing, Factorial Design