Testing the Efficacy of Interactive Alcohol Decision-Making Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Change in Alcohol-Related Consequences
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomly assigned to a condition by a computer program. The entire study will take place online. Participants will not be aware of the condition they are in until after the study ends. Investigators/outcome assessors will only see de-identified data and will have no contact with participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Empathic Statements, MI, Male, No Backstory
Presence of empathic statements and MI techniques. Male narrator. No narrator backstory.
干预措施: Empathic Statements/Reflections (Behavioral)
Empathic Statements, MI, Male, No Backstory
Presence of empathic statements and MI techniques. Male narrator. No narrator backstory.
干预措施: Male Narrator (Behavioral)
Empathic Statements, MI, Male, No Backstory
Presence of empathic statements and MI techniques. Male narrator. No narrator backstory.
干预措施: MI Techniques (Behavioral)
No Empathic Statements, No MI, Female, No Backstory
No empathic statements, MI techniques or narrator backstory. Female narrator
干预措施: Female Narrator (Behavioral)
No Empathic Statements, No MI, Female, Backstory
No empathic statements or MI techniques. Presence of narrator backstory. Female narrator
干预措施: Narrator Backstory (Behavioral)
No Empathic Statements, No MI, Female, Backstory
No empathic statements or MI techniques. Presence of narrator backstory. Female narrator
干预措施: Female Narrator (Behavioral)
Empathic Statements, MI, Female, Backstory
Presence of empathic statements, MI techniques and narrator backstory. Female narrator
干预措施: Empathic Statements/Reflections (Behavioral)
Empathic Statements, MI, Female, Backstory
Presence of empathic statements, MI techniques and narrator backstory. Female narrator
干预措施: Narrator Backstory (Behavioral)
Empathic Statements, MI, Female, Backstory
Presence of empathic statements, MI techniques and narrator backstory. Female narrator
干预措施: Female Narrator (Behavioral)
Empathic Statements, MI, Female, Backstory
Presence of empathic statements, MI techniques and narrator backstory. Female narrator
干预措施: MI Techniques (Behavioral)
No Empathic Statements, No MI, Male, No Backstory
No empathic statements, MI techniques or narrator backstory. Male narrator
干预措施: Male Narrator (Behavioral)
Empathic Statements, MI, Male, Backstory
Presence of empathic statements, MI techniques and narrator backstory. Male narrator.
干预措施: Empathic Statements/Reflections (Behavioral)
Empathic Statements, MI, Male, Backstory
Presence of empathic statements, MI techniques and narrator backstory. Male narrator.
干预措施: Narrator Backstory (Behavioral)
Empathic Statements, MI, Male, Backstory
Presence of empathic statements, MI techniques and narrator backstory. Male narrator.
干预措施: Male Narrator (Behavioral)
Empathic Statements, MI, Male, Backstory
Presence of empathic statements, MI techniques and narrator backstory. Male narrator.
干预措施: MI Techniques (Behavioral)
No Empathic Statements, MI, Female, Backstory
Presence of MI techniques and narrator backstory. No empathic statements. Female narrator.
干预措施: Narrator Backstory (Behavioral)
No Empathic Statements, MI, Female, Backstory
Presence of MI techniques and narrator backstory. No empathic statements. Female narrator.
干预措施: Female Narrator (Behavioral)
No Empathic Statements, MI, Female, Backstory
Presence of MI techniques and narrator backstory. No empathic statements. Female narrator.
干预措施: MI Techniques (Behavioral)
Empathic Statements, No MI, Male, No Backstory
Presence of empathic statements. No MI techniques or narrator backstory. Male narrator.
干预措施: Empathic Statements/Reflections (Behavioral)
Empathic Statements, No MI, Male, No Backstory
Presence of empathic statements. No MI techniques or narrator backstory. Male narrator.
干预措施: Male Narrator (Behavioral)
No Empathic Statements, MI, Male, Backstory
Presence of MI techniques and narrator backstory. No empathic statements. Male narrator.
干预措施: Narrator Backstory (Behavioral)
No Empathic Statements, MI, Male, Backstory
Presence of MI techniques and narrator backstory. No empathic statements. Male narrator.
干预措施: Male Narrator (Behavioral)
No Empathic Statements, MI, Male, Backstory
Presence of MI techniques and narrator backstory. No empathic statements. Male narrator.
干预措施: MI Techniques (Behavioral)
Empathic Statements, No MI, Female, No Backstory
Presence of empathic statements. No MI techniques or narrator backstory. Female narrator.
干预措施: Empathic Statements/Reflections (Behavioral)
Empathic Statements, No MI, Female, No Backstory
Presence of empathic statements. No MI techniques or narrator backstory. Female narrator.
干预措施: Female Narrator (Behavioral)
Empathic Statements, MI, Female, No Backstory
Presence of empathic statements and MI techniques. Female narrator. No narrator backstory.
干预措施: Empathic Statements/Reflections (Behavioral)
Empathic Statements, MI, Female, No Backstory
Presence of empathic statements and MI techniques. Female narrator. No narrator backstory.
干预措施: Female Narrator (Behavioral)
Empathic Statements, MI, Female, No Backstory
Presence of empathic statements and MI techniques. Female narrator. No narrator backstory.
干预措施: MI Techniques (Behavioral)
No Empathic Statements, No MI, Male, Backstory
Presence of narrator backstory. No empathic statements or MI techniques. Male narrator.
干预措施: Narrator Backstory (Behavioral)
No Empathic Statements, No MI, Male, Backstory
Presence of narrator backstory. No empathic statements or MI techniques. Male narrator.
干预措施: Male Narrator (Behavioral)
Empathic Statements, No MI, Female, Backstory
Presence of empathic statements and narrator backstory. No MI techniques. Female narrator.
干预措施: Empathic Statements/Reflections (Behavioral)
Empathic Statements, No MI, Female, Backstory
Presence of empathic statements and narrator backstory. No MI techniques. Female narrator.
干预措施: Narrator Backstory (Behavioral)
Empathic Statements, No MI, Female, Backstory
Presence of empathic statements and narrator backstory. No MI techniques. Female narrator.
干预措施: Female Narrator (Behavioral)
Empathic Statements, No MI, Male, Backstory
Presence of empathic statements and narrator backstory. No MI techniques. Male narrator.
干预措施: Empathic Statements/Reflections (Behavioral)
Empathic Statements, No MI, Male, Backstory
Presence of empathic statements and narrator backstory. No MI techniques. Male narrator.
干预措施: Narrator Backstory (Behavioral)
Empathic Statements, No MI, Male, Backstory
Presence of empathic statements and narrator backstory. No MI techniques. Male narrator.
干预措施: Male Narrator (Behavioral)
No Empathic Statements, MI, Female, No Backstory
Presence of MI techniques. No empathic statements or narrator backstory. Female narrator.
干预措施: Female Narrator (Behavioral)
No Empathic Statements, MI, Female, No Backstory
Presence of MI techniques. No empathic statements or narrator backstory. Female narrator.
干预措施: MI Techniques (Behavioral)
No Empathic Statements, MI, Male, No Backstory
Presence of MI techniques. No empathic statements or narrator backstory. Male narrator.
干预措施: Male Narrator (Behavioral)
No Empathic Statements, MI, Male, No Backstory
Presence of MI techniques. No empathic statements or narrator backstory. Male narrator.
干预措施: MI Techniques (Behavioral)
结局指标
主要结局
Change in Alcohol-Related Consequences
时间窗: Given pre-intervention and at 1-month follow-up
Assessed with the Brief Young Adult Alcohol Consequences Questionnaire which assess the occurrence/ non-occurrence of 24 alcohol consequences.
Participant Satisfaction with the Intervention
时间窗: Given immediately after completing the intervention
Fifteen item measure assessing how much participants liked the intervention and felt respected by it.
Change in Quantity and Frequency of Alcohol Use
时间窗: Given pre-intervention and at 1-month follow-up
The Timeline Followback Questionnaire (TLFB) will be given to assess past month alcohol use.
次要结局
未报告次要终点
研究者
Emily Grekin
Associate Professor
Wayne State University