Strategies: Motivational Interviewing/Psychoeducation
Condition: Alcohol Use, Underage; Substance Use; Underage Drinking
MeSH terms: Substance-Related Disorders; Underage Drinking
Study type: Interventional

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.
    

Detailed description: 
      Study Design. Following screening and giving informed assent/consent, eligible participants
      will be randomly assigned to one of two study conditions: (1) MI: Two hour session of
      therapist administered MI, and (2) PE: Two hour session of therapist assisted viewing and
      discussion of educational DVDs about adolescent alcohol use, drug use, and driving under the
      influence provided by Human Relations Media, Mount Kisco, NY (hrmvideo.com).

      Interventions will be curriculum based in that each session will be introduced by the leader
      with a brief description of problems associated with underage drinking, underage binge
      drinking, underage tobacco and other drug use, and driving while intoxicated. Participants
      will be randomly assigned to the MI or PE condition, but will be able to choose an individual
      or group intervention format. In a preliminary study, the investigators have found that many
      youth prefer a group format. Both individual and group formats have been successfully used
      previously in this population.

      Assessments will be carried out pre-intervention and once within 18 months post-intervention.
      Pre-intervention assessments will be carried out in person and post-intervention assessments
      will be done in person, by telephone, or be web-based using questionnaires developed at Brown
      University and previously used successfully in youth in this population. Participating youth
      will be paid $75 for the initial two hour intervention and $75 for completing the follow-up.
      The payments will be in the form of Target or other department store gift cards. All
      questionnaires will be available on scannable paper forms or as a web-based application to
      permit ease and accuracy of data transmittal to a database for evaluation.

      Measures: In addition to collecting demographic data, the following measures will be used
      pre-intervention (MI or PE) and at follow-up: Adolescent Drinking Questionnaire (ADQ), Drug
      Use Questionnaire, Drinking and Drug Use Driving Scale, Tobacco Use Scale, Injury behavior
      checklist, Student Self Check, Relationship with Parent/Guardian - Most Important, Teen
      Monitoring (Chassin), Peer Substance Use, Peer Tolerance of Substance Use, Stage of Change
      Assessment, MI Adherence Checklist (for the MI sessions only).

      Examples of potential factors include information transfer, change in beliefs, internalizing
      new norms, resolving ambivalence, establishing increased autonomy, empowering for change,
      peer modeling, and peer support. The investigators will assess 1) these change factors, 2)
      the participant's movement along the stages of behavior change to a new level of
      drinking/drug use, and 3) self-reported changes in drinking, drug use, and intoxicated
      driving. With these data the investigators will be able to determine not only the overall
      efficacy of the MI vs. PE intervention in decreasing alcohol and drug use and intoxicated
      driving, but also the type of behavior change (e.g., moving from pre-contemplation to action)
      and the variables associated with that change (e.g., internalizing new norms, increased
      autonomy, peer support).

      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).

      In the PE intervention, participants will view all four DVDs (all DVDs available from Human
      Relations Media):

      Session 1: Underage Drinking: Know the Facts, Know the Risks describes negative consequences
      of youth alcohol abuse, including deaths resulting from drunk driving, and alcohol poisoning.

      Session 2: Too Much: Extreme Danger of Binge-Drinking presents information specifically about
      the physiology of how binge drinking can cause death, and an interview with a parent of a
      student who died from alcohol poisoning while partying with his friends.

      Session 3: Everything You Need to Know About Substance Abuse in 22 Minutes outlines alcohol,
      tobacco, and other drugs' effects.

      Session 4: Dying High 2: Real Stories of Drugged Driving shows consequences of driving under
      the influence.

      Training in MI. Under the supervision of Dr. Gilder, at least six training workshops will be
      held with Tribal clinic study staff to deliver culturally appropriate MI to adolescent Native
      Americans. Workshop leaders will be Motivational Interviewing Network of Trainers (MINT)
      certified PhD-level trainers with expertise in working with American Indian/Alaska Native
      populations.

      Assessment of MI fidelity. Since tribal leaders and parents, citing confidentiality and
      cultural concerns, stated that audio- and video-taping of MI sessions would not be
      acceptable, the investigators will assess the MI sessions with the Adherence Checklist -
      Individual and Group MI Prevention Session. The checklist contains 14 items which assess the
      session's process and content and the therapist's adhering to the principles of MI. Items
      include asking if the therapist discussed the pros and cons of changing behavior, and
      introduced a change plan worksheet to the participant. Therapist fidelity to MI will be
      assessed both during training and on an ongoing basis every 6 months during the study using
      the MI Adherence checklist. If the average total checklist score of adherence falls below
      80%, a quality improvement program will be instituted to identify the problem(s) and correct
      it with additional training.

      Follow-Up. The investigators believe, given the success of the preliminary pilot study in
      recruiting reservation youth to the initial assessment and intervention, that successful
      follow-up of participants represents the main potential problem for the study. These
      obstacles were overcome, at least in part, by 1) instituting a web-based assessment that
      adolescents can take any time, including free time at school; 2) keeping email and regular
      mail addresses of participants current; 3) increasing payment for follow-up; 4) instituting
      follow-up in conjunction with a program the adolescent is participating in, i.e. after school
      youth program, and appointments at the clinic for medical and dental services. The Tribal IRB
      has given permission for the web-based assessment.

      This intervention study aims to recruit 150 participants to each intervention condition for a
      total enrollment of 300 youth participants ages 13-20 years. Evaluation will be designed to
      test that MI is more effective than the PE in reducing alcohol and drug use and intoxicated
      driving at follow-up. Evaluations to test that MI is more effective than the PE in reducing
      alcohol and drug use will be undertaken as follows: The primary outcome variables will be: in
      the previous 6 months (1) quantity x frequency of drinking, (2) frequency of binge drinking
      and being drunk; (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; (4) drinking or using drugs and driving and/or being a
      passenger in a car with a driver who has been using alcohol or drugs; (5) a negative
      consequences of drinking or using drugs composite score.

      Descriptive statistics will be generated for each variable. Statistical analyses assessing MI
      vs. PE differences will be assessed as follows. For dichotomous variables, repeated-measures
      chi-square analyses will be used. For continuous variables, repeated measures analysis of
      variance (ANOVA) or analysis of covariance (ANCOVA) will be used. The Mann-Whitney Test will
      be used for continuous variables that are not normally distributed. Repeated measures of
      ordinal data for two time points will be assessed using the Wilcoxin Signed Ranks Test. With
      2 groups, 150 participants in each group, an alpha = 0.01 to avoid a Type 1 error, a medium
      effect size for the group of dependent variables analyzed in chi-square, ANOVA, and logistic
      regression analyses, and a Bonferroni correction for 5 multiple comparisons in each set of
      analyses, the power at the projected n for chi-square, ANOVA, and logistic regression will be
      0.96, 0.96, and >0.80, respectively. Power estimates were made using G*Power 3.61. If sample
      size permits, a larger model examining the association of selected outcome variables (e.g.,
      frequency of bingeing and drinking/driving in the past 6 months) with independent variables
      (e.g., age, gender, stage of change, MI vs. PE intervention) in multiple and logistic
      regression models will also be evaluated.
    

Intervention name(s): Motivational Interviewing; Psychoeducation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 2 hours of motivational interviewing; 2 hours of DVD viewing and discussion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Allocation: Randomized Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: American Indian