Strategies: Motivational Interviewing/Psychoeducation

NCT03458299 | Completed DMC

• 1 other identifier: R01AA023755
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research program is to implement and evaluate complementary interventions designed to address underage alcohol, marijuana, tobacco and other drug use and abuse among Native American youth residing in and around nine contiguous Indian reservations in rural portions of a Southern California county. Component 1. Motivational Interviewing (MI) Evaluations (Identified PHI). Approximately 150 participants between 13 and 20 years of age will participate in the Motivational Interviewing (MI) intervention and one follow-up assessment over an 18 month period. Questionnaires of youth substance use and access patterns will be by phone or self-administered using paper, iPad, and web-based surveys. Formal informed consent from participants 18 and older and assent and parental/legal guardian consent will be obtained from those participants under 18. Component 2. Psychoeducation (PE) Evaluations (Identified PHI). Approximately 150 participants between 13 and 20 years of age will participate in the Psychoeducation (PE) intervention and one follow-up assessment over an 18 month period. Questionnaires of youth substance use and access patterns will be by phone or self-administered using paper, iPad, and web-based surveys. Formal informed consent from participants 18 and older and assent and parental/legal guardian consent will be obtained from those participants under 18.

Conditions

Alcohol Use, Underage; Substance Use; Underage Drinking

Keywords

American Indian

Outcome Measures

Primary Outcomes (5)

• (1) Drinking QF

  (1) quantity x frequency of drinking. \[Quantity: 1, More than 10 standard drinks; 2, Between 7 and 9 standard drinks; 3, Between 5 and 6 standard drinks; 4, 4 standard drinks; 5, 3 standard drinks; 6, 2 standard drinks; 7, 1 standard drink; 8, I did not drink alcohol in the past 6 months\] \[Frequency: 1, Everyday; 2, 4-6 days a week, 3, 2-3 days a week; 4, once a week; 5, Less than once a week, but more than once a month, 6, Once a month 7, Less than once a month, 8, I did not drink alcohol in the past 6 months\]. Analysis: These points are inverted so that higher numbers denote higher drinking frequencies and quantities \[worse outcome\] and lower numbers denoted lower frequencies and quantities \[better outcome\]. A single quantity × frequency of drinking variable will be constructed by multiplying the frequency and quantity variables.

  in the previous 6 months

• (2) Binge drinking/being drunk Frequency

  (2) frequency of binge drinking and being drunk. Binge (female): Over the PAST 6 MONTHS, when you were drinking how many times you did drink four or more drinks (of beer, wine, or liquor) Binge (male): Over the PAST 6 MONTHS, when you were drinking how many times you did drink five or more drinks (of beer, wine, or liquor) \[1. Everyday - worse outcome; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week; 5. Less than once a week, but more than once a month; 6. Once a month; 7. Less than once a month 8. Never - better outcome\]. Drunk: 3\. Over the PAST 6 MONTHS, about how many times have you gotten drunk (drunk means you couldn't talk clearly and it was difficult to keep your balance) on alcohol? \[1. Everyday - worse outcome; 2. 4-6 days a week; 3. 2-3 days a week; 4. Once a week; 5. Less than once a week, but more than once a month; 6. Once a month; 7. Less than once a month 8. Never - better outcome\].

  in the previous 6 months

• (3) Commercial Tobacco and Other Drug Use days

  (3) number of days used cigarettes, other forms of tobacco, e-cigarettes and nicotine inhalant devices, cannabis, "Spice," stimulants, opiates, cough syrup, inhalants, hallucinogens, and benzodiazepines \[lower numbers = better outcome, higher numbers = worse outcome\]

  in the previous 6 months

• (4) DUI/RWDD days

  (4) drinking or using drugs and driving \[During the PAST 6 MONTHS, how many times did you drive after you had been drinking? and During the PAST 6 MONTHS, how many times did you drive after you had been using drugs? - lower numbers = better outcome, higher numbers = worse outcome\] and/or being a passenger in a car with a driver who has been using alcohol or drugs \[During the PAST 6 MONTHS, how many times did you ride in a car with a driver who had been drinking? and 7. During the PAST 6 MONTHS, how many times did you ride in a car with a driver who had been using drugs? - lower numbers = better outcome, higher numbers = worse outcome\]

  in the previous 6 months

• (5) negative consequences of drinking or using drugs composite

  (5) a composite score of negative consequences of drinking or using drugs. In the past 6 months, how many times were you injured by: 1. Being physically attacked? (If teen response is ≥ 1, continue. If teen response is 0, skip to #2); a. How many of these times were you treated by a doctor or nurse for the injury(ies)? b. How many of these times had you been drinking alcohol about the time of the injury(ies)? c. How many of these times had you been using drugs about the time of the injury(ies)? 2. Being in a physical fight with someone? (Do NOT include any attacks listed in previous question). a.-c. as above. 3. Accidently getting cut? a.-c. as above. 4. Falling? a.-c. as above. 5. A motor vehicle accident when you were driving? a.-c. as above. 6. A motor vehicle accident when you were not the driver? a.-c. as above. \[Analysis: sum of responses; - lower numbers = better outcome, higher numbers = worse outcome\]

  in the previous 6 months

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

The MI intervention will incorporate open-ended questions, personalized feedback, and discussion about participants' alcohol use and drug, associated risk behaviors (e.g., drinking and driving), and the consequences of these behaviors. Individual MI procedures will incorporate the core principles of MI described by Miller and Rollnick, including expressing empathy, developing discrepancy, rolling with resistance, and supporting self-efficacy. Therapist interventions will be tailored to the participants' readiness to change/current stage of change (pre-contemplation, contemplation, preparation, action, maintenance, and relapse).

Behavioral: Motivational Interviewing

Psychoeducation

EXPERIMENTAL

The Psychoeducation session will consist of therapist assisted viewing and discussion of four educational DVDs about adolescent alcohol use, drug use, and driving under the influence provided by Human Relations Media, Mount Kisco, NY (hrmvideo.com).

Behavioral: Psychoeducation

Interventions

Motivational Interviewing BEHAVIORAL

2 hours of motivational interviewing

Motivational Interviewing

Psychoeducation BEHAVIORAL

2 hours of DVD viewing and discussion

Psychoeducation

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• between the ages of 13 and 20
• residing in catchment area of Tribal clinic
• ability to give informed consent/assent and absence of physical or emotional health issues sufficient to impair the ability to participate in the research

You may not qualify if:

• inability to give informed consent/assent or the presence of physical or emotional health issues sufficient to impair the ability to participate in the research.

Sponsors & Collaborators

• Pacific Institute for Research and Evaluation: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• The Scripps Research Institute: collaborator

Study Sites (1)

Southern California Tribal Health Center

Valley Center, California, 92082, United States

Location

MeSH Terms

Conditions

Underage Drinking; Substance-Related Disorders

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Adolescent Behavior; Behavior; Alcohol Drinking; Drinking Behavior; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Roland S Moore, PhD

  Pacific Institute for Research and Evaluation

  PRINCIPAL INVESTIGATOR

• David A Gilder, MD

  The Scripps Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center Director and Senior Research Scientist

Model Details: Allocation: Randomized Intervention Model: Parallel Assignment

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: March 8, 2018
• Study Start: January 23, 2018
• Primary Completion: February 9, 2022
• Study Completion: February 9, 2022
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)