An Adaptive Intervention for p Reducing College Student Alcohol R - PowerPoint PPT Presentation

An Adaptive Intervention for p Reducing College Student Alcohol ‐ R l t d C Related Consequences: A SMART Pilot Study Proposal Megan Patrick & Daniel Almirall SRC, ISR, University of Michigan Center for the Study of Health and Risk Behaviors Univ. of Washington—March 27, 2012 Univ. of Washington March 27, 2012

The slide I don’t need at C ‐ SHRB. The slide I don t need at C SHRB. • College alcohol and associated negative College alcohol and associated negative consequences are clear public health problems • Heavy drinking at age 18 has long term impact • Heavy drinking at age 18 has long ‐ term impact, including symptoms of AUD in adulthood • Scarce intervention resources must be used as S i i b d wisely as possible to address college student alcohol use l h l

Another slide I don’t need at C ‐ SHRB. • Brief motivational interventions are efficacious • Our thinking is this • Our thinking is this… – Web ‐ based versions of BMI, which are suitable as universal interventions are especially resource universal interventions, are especially resource ‐ efficient and have shown promising effects. – In ‐ person BMIs (e.g., BASICS), which due to their In person BMIs (e g BASICS) which due to their intensity may be more suitable as indicated interventions, have a strong evidence base. , g

One way to address heavy drinking while conserving resources is to i i • first utilize universal interventions, • identify students in need of additional y treatment, • and then move these students to a more and then move these students to a more intensive, indicated intervention. This package of sequenced treatments (universal f ll followed by indicated) is a form of adaptive d b i di t d) i f f d ti intervention .

One (Somewhat Simple) Example of an Adaptive Intervention an Adaptive Intervention Baseline: @ Week 6 > Week 6 Week 0 Binge ‐ In ‐ person Web ‐ based BMI: drinker BASICS delivered one week prior to week prior to beginning of Fall Non Watchful semester Binge ‐ Waiting drinkers Binge drinking at Week 6 is defined as 4+/5+ drinks from women/men in 2 or more settings over the past 6 weeks. Web-based BMI is a 5 component (intended drinking, expected consequences, social norms, goal-directed motivations, protective behavioral strategies) personalized feedback intervention based on responses to the baseline survey. p p y In-person BASICS (2 session program) will be delivered by a University Health Services professional. BASICS is freely available at the Univ. of Michigan.

Some key issues—useful for building an optimal adaptive intervention— ti l d ti i t ti remain untested in the science of brief alcohol interventions. • The optimal timing of universal BMI: Do we intervene with a web ‐ based BMI prior to or after intervene with a web based BMI prior to or after the beginning of Fall semester? • Among students who continue to binge drink • Among students who continue to binge ‐ drink despite the universal treatment, what is the added value of a BASICS over a web based BMI Booster? value of a BASICS over a web ‐ based BMI Booster?

SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIAL (SMART) Study Design to develop an adaptive intervention to prevent and treat college drinking Measures and @ Week 6 Outcomes : BASICS PROGRAM A Binge ‐ R @ Weekly: drinking drinkers EARLY BMI : quantity and quantity and WEB ‐ BASED BMI S Web ‐ based B BOOSTERS @ Week 0: duration on each intervention 1 Week prior delivered prior day of the previous to the Fall to Fall week, along with a semester semester Non Binge ‐ Non Binge ‐ WATCHFUL WAITING WATCHFUL WAITING C C checklist of drinkers consequences and SAMPLE: their evaluations. R @ Weeks 0 6 12: @ Weeks 0, 6, 12: College College Freshmen Intentions for BASICS PROGRAM D drinking, perceived Binge ‐ R norms, motivations, drinkers DELAYED BMI : DELAYED BMI expected and eval. WEB ‐ BASED BMI E Web ‐ based BOOSTERS of conseq., protect. intervention delivered after behav. strategies, Fall semester health service health service begins begins N Non Binge ‐ Bi WATCHFUL WAITING F utilization, GPA drinkers Web-based BMI Boosters includes content that is tailored using updated information.

Specific Aims of the SMART • Aim 1 (Timing Question) : To determine the maximally effective timeframe to deliver the universal, web ‐ based BMI. • Aim 2 (Best Second Stage Treatment) : To determine whether web ‐ ( d ) d h h b based boosters versus BASICS is the best treatment among participants who exhibit binge ‐ drinking despite the initial web ‐ p p g g p based BMI. • Aim 3 (Best Adaptive Intervention) : To determine which is the best of the 4 pre ‐ specified adaptive interventions. • Aim 4 (Tailoring) : To determine (i) the types of individuals (on the basis of baseline measures e g age race intentions to rush) basis of baseline measures, e.g., age, race, intentions to rush) more or less likely to benefit from early vs delayed BMI delivery, (ii) the types of binge ‐ drinkers (on the basis of baseline measures, and outcomes to initial treatment) more or less likely to benefit from web ‐ based boosters vs BASICS.

The 4 Embedded Adaptive Interventions Any One Participant May Be Assigned To ADAPTIVE INTERVENTION #1 ADAPTIVE INTERVENTION #2 WEB BASED BMI WEB ‐ BASED BMI EARLY BMI : EARLY BMI : Binge ‐ Binge Binge ‐ EARLY BMI : BASICS PROGRAM drinkers BOOSTERS Web ‐ based drinkers Web ‐ based intervention intervention delivered prior delivered prior to the Fall to the Fall semester semester Non Binge ‐ g WATCHFUL WAITING WATCHFUL WAITING Non Binge ‐ Non Binge ‐ semester semester WATCHFUL WAITING WATCHFUL WAITING drinkers drinkers ADAPTIVE INTERVENTION #3 ADAPTIVE INTERVENTION #4 WEB ‐ BASED BMI DELAYED BMI : Binge ‐ Binge ‐ DELAYED BMI : BASICS PROGRAM drinkers BOOSTERS Web ‐ based drinkers Web ‐ based intervention intervention delivered after delivered after Fall semester Fall semester Fall semester Fall semester begins Non Binge ‐ WATCHFUL WAITING Non Binge ‐ begins WATCHFUL WAITING drinkers drinkers

Specific Aims of the SMART Pilot • Aim 1: To develop and refine the adaptive interventions to b be evaluated in the SMART. Includes developing and l t d i th SMART I l d d l i d refining components of the initial web ‐ based BMI and boosters and developing the protocol for linking students boosters, and developing the protocol for linking students between the initial web ‐ based BMI to the in ‐ person BASICS program. p g • Aim 2: To conduct a pilot SMART study to address acceptability and feasibility concerns about the SMART study design. The pilot SMART will provide (i) provide investigators with the experience to conduct a SMART, and (ii) (ii) preliminary data for an R01 to be submitted to the li i d t f R01 t b b itt d t th NIAAA to fund a larger ‐ scale SMART.

Why do a SMART pilot first? Aim 1: Develop and refine intervention modalities Aim 1: Develop and refine intervention modalities • Focus groups before (show mock ‐ ups) and after • How do we link binge ‐ drinkers to UM BASICS? H d li k bi d i k UM BASICS? Aim 2: Feasibility and acceptability • Can we consent and engage prior to Fall? • How do we link binge ‐ drinkers to UM BASICS? How do we link binge drinkers to UM BASICS? • How do we classify students (for purposes of 2 nd line txt) who fail to provide Week 6 binge status? line txt) who fail to provide Week 6 binge status? • Get %age of students who meet binge threshold • Infrastructure for multiple randomizations • Can we deliver web ‐ based BMI boosters via text?

3 questions to the group for discussion • What else do you anticipate is important for What else do you anticipate is important for us to think about in the Pilot study? • Do you have points of concern/confusion • Do you have points of concern/confusion about the methodology? • Do you have points of concern/confusion D h i f / f i about the scientific justification for this study?

The Interventions Assigned from the Participant’s Point of View . There are 6 sequences of treatment that are possible. Txt Sequence A Txt Sequence D EARLY BMI : DELAYED BMI : Web ‐ based Web ‐ based intervention intervention Binge ‐ Binge ‐ BASICS PROGRAM BASICS PROGRAM delivered prior p drinkers delivered after drinkers to the Fall Fall semester semester begins Txt Sequence B Txt Sequence B Txt Sequence E Txt Sequence E EARLY BMI : DELAYED BMI : Web ‐ based Web ‐ based intervention intervention WEB ‐ BASED BMI WEB ‐ BASED BMI Binge ‐ Binge ‐ delivered prior delivered after drinkers BOOSTERS drinkers BOOSTERS to the Fall Fall semester semester begins Txt Sequence C Txt Sequence C Txt Sequence F Txt Sequence F EARLY BMI : DELAYED BMI : Web ‐ based Web ‐ based intervention intervention Non Binge ‐ Non Binge ‐ WATCHFUL WAITING WATCHFUL WAITING delivered prior drinkers delivered after drinkers to the Fall Fall semester semester begins