University Medical Center of El Paso
El Paso, Texas, 79905, United States
Location status: Recruiting
NCT Number: NCT05800899
This Stage II Randomized Efficacy Trial will compare the effectiveness of a theoretically informed and culturally responsive brief motivational intervention to a non-adapted brief intervention among non-treatment seeking Latinxs admitted for medical treatment of an injury who engage in at risk drinking or were drinking at the time of their injury. The culturally informed brief motivational intervention (CI-BMI) increases autonomous motivation to engage in protective drinking behavior and reduce alcohol problems while addressing barriers to help seeking and facilitating treatment utilization. This project will address the alcohol related health disparities and treatment inequities among Latinx who are more likely to experience alcohol problems yet less likely to receive treatment in order to reduce the negative public health impact of alcohol.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
El Paso, Texas, 79905, United States
Location status: Recruiting
Our prior Stage III Randomized Clinical Trial (n=1496) evaluating ethnic differences in response to brief intervention showed that, compared to non-Latinxs Whites, Latinxs were more likely to reduce alcohol use in response to standard brief alcohol interventions that are not adapted to be culturally responsive (NA-BMI) versus treatment as usual1. In Stage I Community Based Participatory Research (Stage I CBPR), we developed a culturally informed brief motivational intervention (CI-BMI) which adopts a harm reduction approach and focuses on reducing alcohol problems and increasing treatment utilization 2. Through a flexible core approach, CI-BMI introduces substantial modifications to standard brief alcohol interventions to be culturally responsive and is theoretically grounded in self-determination theory (SDT)3-5. The result of Stage I CBPR was CI-BMI which 1) leverages cultural values and strengths while addressing the process of acculturation and acculturative stress; 2) is explicitly designed to meet the basic psychological needs of autonomy, relatedness, and competence by supporting autonomy to enhance autonomous motivation to change drinking behavior; and 3) focuses on harm reduction. Our Stage I CBPR (n=87) demonstrated that CIBMI is feasible and acceptable in pretesting in a Level I Trauma Center5. We hypothesize that CI-BMI will lead to increased engagement in protective drinking behaviors, fewer alcohol problems as well as reduce barriers to help seeking and increase treatment utilization among underserved, non-treatment seeking Latinxs who engage in at risk drinking and are seriously injured. The proposed Stage II Efficacy Trial of CI-BMI will randomize 600 Latinxs admitted to a Level I Trauma Center at University Medical Center in El Paso, Texas to either NA-BMI or CI-BMI conducted by research staff from The University of Texas El Paso. Following admission for medical treatment of an injury, eligible Latinx patients will be those who screen positive for drinking at the time of their injury or engage in at risk drinking. The primary aims of the proposed study are to
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard non-adapted brief motivational interviewing based on motivational interviewing.
culturally adapted brief motivational interviewing based on motivational interviewing.
Time frame: Baseline and 3 month
The 20-item Protective Behavioral Strategies Scale (PBSS) will be used to quantify the engagement in harm reduction behaviors which will be assessed at baseline, three, six and twelve month follow up. The PBSS consists of three subscales that reflect different types of strategies: stopping/limiting drinking (7 items), manner of drinking (5 items), and serious harm reduction (3 items). Participants are instructed to rate the degree to which they engage in PBS on a 6-point response scale ranging from 1 (Never) to 6 (Always). change=(3 month -baseline score)
Time frame: Baseline and 6 month
The 20-item Protective Behavioral Strategies Scale (PBSS) will be used to quantify the engagement in harm reduction behaviors which will be assessed at baseline, three, six and twelve month follow up. The PBSS consists of three subscales that reflect different types of strategies: stopping/limiting drinking (7 items), manner of drinking (5 items), and serious harm reduction (3 items). Participants are instructed to rate the degree to which they engage in PBS on a 6-point response scale ranging from 1 (Never) to 6 (Always). change=(6 month -baseline score)
Time frame: Baseline and 12 month
The 20-item Protective Behavioral Strategies Scale (PBSS) will be used to quantify the engagement in harm reduction behaviors which will be assessed at baseline, three, six and twelve month follow up. The PBSS consists of three subscales that reflect different types of strategies: stopping/limiting drinking (7 items), manner of drinking (5 items), and serious harm reduction (3 items). Participants are instructed to rate the degree to which they engage in PBS on a 6-point response scale ranging from 1 (Never) to 6 (Always). change=(12 month -baseline score)
Time frame: Baseline and 3 month
Participants are asked to indicate how often they have experienced each of 15 consequences listed in the items. Each item is responded to on a 5-point response scale ranging from 0 (Never) to 4 (Daily or almost daily). The 15 items will be summed to create a total score. Change = (3-month -baseline score)
Time frame: Baseline and 6 month
Participants are asked to indicate how often they have experienced each of 15 consequences listed in the items. Each item is responded to on a 5-point response scale ranging from 0 (Never) to 4 (Daily or almost daily). The 15 items will be summed to create a total score. Change = (6 -month -baseline score)
Time frame: Baseline and 12-month
Participants are asked to indicate how often they have experienced each of 15 consequences listed in the items. Each item is responded to on a 5-point response scale ranging from 0 (Never) to 4 (Daily or almost daily). The 15 items will be summed to create a total score. Change = (12-month -baseline score)
Time frame: Baseline and 3-month
To asses an individuals attitudes towards alcohol services and treatment the Barriers to Help Seeking Scale (BSAT) measure will be used. The measure utilizes 53 total questions and consist of ten different domains (alcohol treatment, drinking goals, cultural background, immigration, drinking perceptions, feelings towards alcohol treatment services, friends and family, accessing services, life responsibilities, and treatment seeking). Each subscale is summed for a total subscale score (1 strongly agree to 5 strongly disagree). Change = (3month -baseline score)
Time frame: Baseline and 6-month
To asses an individuals attitudes towards alcohol services and treatment the Barriers to Help Seeking Scale (BSAT) measure will be used. The measure utilizes 53 total questions and consist of ten different domains (alcohol treatment, drinking goals, cultural background, immigration, drinking perceptions, feelings towards alcohol treatment services, friends and family, accessing services, life responsibilities, and treatment seeking). Each subscale is summed for a total subscale score (1 strongly agree to 5 strongly disagree). Change = (6 month -baseline score)
Time frame: Baseline and 12-month
To asses an individuals attitudes towards alcohol services and treatment the Barriers to Help Seeking Scale (BSAT) measure will be used. The measure utilizes 53 total questions and consist of ten different domains (alcohol treatment, drinking goals, cultural background, immigration, drinking perceptions, feelings towards alcohol treatment services, friends and family, accessing services, life responsibilities, and treatment seeking). Each subscale is summed for a total subscale score (1 strongly agree to 5 strongly disagree). Change = (12 month -baseline score)
Time frame: Baseline and 3-month
Participants are first asked, "Have you ever gone anywhere or seen anyone for a reason that was related in any way to your drinking - a physician, counselor, Alcoholics Anonymous, or any other community agency or professional?" Participants who respond yes to this first item are told, "I am going to read you a list of community agencies and professionals. For each one, please tell me if you have ever gone for any reason related to your drinking." A list of thirteen types of treatment providers are listed. The 13 items will be summed to create a total score. Change = (3month -baseline score)
Time frame: Baseline and 6-month
Participants are first asked, "Have you ever gone anywhere or seen anyone for a reason that was related in any way to your drinking - a physician, counselor, Alcoholics Anonymous, or any other community agency or professional?" Participants who respond yes to this first item are told, "I am going to read you a list of community agencies and professionals. For each one, please tell me if you have ever gone for any reason related to your drinking." A list of thirteen types of treatment providers are listed. The 13 items will be summed to create a total score. Change = (6 month -baseline score)
Time frame: Baseline and 12-month
Participants are first asked, "Have you ever gone anywhere or seen anyone for a reason that was related in any way to your drinking - a physician, counselor, Alcoholics Anonymous, or any other community agency or professional?" Participants who respond yes to this first item are told, "I am going to read you a list of community agencies and professionals. For each one, please tell me if you have ever gone for any reason related to your drinking." A list of thirteen types of treatment providers are listed. The 13 items will be summed to create a total score. Change = (12 month -baseline score)
Time frame: Baseline and 6-month
Quality of life will be assessed using the World Health Organization Quality of Life (WHOQoL) using This allows us to measure to assess quality of life (QOL) within the context of an individual's culture, values system, personal goals, standards and concerns. The measure has 26 items (1 never to 5 always). Items are summed for a total score. Change = (6 month -baseline score)
Time frame: Baseline and 3-month
The BPNSNF assesses the satisfaction and frustrations of basic psychological needs as defined by Self Determination Theory including autonomy, competence and relatedness. A total of 24 items are used to assess the satisfaction and frustration of each of the three basic psychological needs. Participants are asked to indicate the degree to which a statement about different kinds of experiences in their life. Participants respond on a five-point Likert scale ranging from not true at all to completely true. A total score is created by subtracting the total score from the three frustration subscales (one for each basic psychological need) from the total score of the three satisfaction subscales (one for each basic psychological need) to get an overall score of basic psychological needs. Change = (3month -baseline score)
Time frame: Baseline and 6-month
The BPNSNF assesses the satisfaction and frustrations of basic psychological needs as defined by Self Determination Theory including autonomy, competence and relatedness. A total of 24 items are used to assess the satisfaction and frustration of each of the three basic psychological needs. Participants are asked to indicate the degree to which a statement about different kinds of experiences in their life. Participants respond on a five-point Likert scale ranging from not true at all to completely true. A total score is created by subtracting the total score from the three frustration subscales (one for each basic psychological need) from the total score of the three satisfaction subscales (one for each basic psychological need) to get an overall score of basic psychological needs. Change = (6 month -baseline score)
Time frame: Baseline and 12-month
The BPNSNF assesses the satisfaction and frustrations of basic psychological needs as defined by Self Determination Theory including autonomy, competence and relatedness. A total of 24 items are used to assess the satisfaction and frustration of each of the three basic psychological needs. Participants are asked to indicate the degree to which a statement about different kinds of experiences in their life. Participants respond on a five-point Likert scale ranging from not true at all to completely true. A total score is created by subtracting the total score from the three frustration subscales (one for each basic psychological need) from the total score of the three satisfaction subscales (one for each basic psychological need) to get an overall score of basic psychological needs. Change = (12 month -baseline score)
Time frame: Baseline and 3-month
The measure was designed around Self-determination theories motivational regulations regarding stages of change (amotivation, external regulation, introjected regulation, identified regulation, and integrated regulation). The measure has a total of 53 items and consist of a 7 point-Likert scale ranging from 0 (not true at all) to 7 (very true). Change = (3 month -baseline score)
Time frame: Baseline and 6-month
The measure was designed around Self-determination theories motivational regulations regarding stages of change (amotivation, external regulation, introjected regulation, identified regulation, and integrated regulation). The measure has a total of 53 items and consist of a 7 point-Likert scale ranging from 0 (not true at all) to 7 (very true). Change = (6 month -baseline score)
Time frame: Baseline and 12-month
The measure was designed around Self-determination theories motivational regulations regarding stages of change (amotivation, external regulation, introjected regulation, identified regulation, and integrated regulation). The measure has a total of 53 items and consist of a 7 point-Likert scale ranging from 0 (not true at all) to 7 (very true). Change = (12 month -baseline score)
Contact information is provided by the study sponsor or research team.
Ashley M Lindquist, B.S.
CONTACT
Craig A Field, PhD
CONTACT
University of Texas, El Paso
Other
Stage II Efficacy Trial of a Culturally Informed Brief Intervention to Reduce Alcohol Related Health Disparities and Treatment Inequities Among Latinxs
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