PI: Gerald J. August, Ph.D.
FUNDING: National Institute on Drug Abuse (R34DA037888)
COMMUNITY PARTNER: Natalis Counseling & Psychology Solutions
APPROACH: Comparative Effectiveness Design – using a multiple levels of analysis framework
This study employs a two-group randomized controlled trial to inform the construction of a personalized intervention model to prevent the persistence and escalation of serious conduct problems including alcohol and drug abuse among high risk youth. High risk is defined as referral to a community-based clinic for early drug use involvement. The study seeks to examine moderating effects of personal risk factors representing two theoretically distinct frameworks and determine whether these variables operate independently or in combination to influence the differential efficacy of two models of an adolescent preventive intervention. One model of moderation is based on risk severity (RS) as reflected in individual differences in delay discounting (DD), a form of the impulsivity trait that is positively associated with escalation to more serious levels of abuse and addiction. A second more exploratory model is based on differential sensitivity (DS) theory. The DS framework stipulates that individuals, due to specific sensitivity factors, vary in their responsiveness to environmental influence such as those delivered via an intervention. The study will explore DS markers associated with the reward motivational system, including dopaminergic genes, the post auricular reflex and a high sensory-processing sensitivity trait.
PI: Timothy Piehler, Ph.D.
FUNDING: Institute for Translational Research in Children’s Mental Health
COMMUNITY PARTNER: Fridley High School
APPROACH: Feasibility Trial
This study is evaluating an innovative approach to conduct disorder prevention within a population of high school students, specifically examining the ability of an adolescent mindfulness program (Learning to Breathe) to produce positive changes in self-control, a self-regulatory mechanism associated with conduct disorder development. The primary goal of this pilot study is to demonstrate feasibility including (a) rates of study referrals, rates of recruitment, and number of trial completers (attrition); (b) acceptability of the Learning to Breathe and Skills for Success programs as rated by the youth; (c) feasibility of the assessment battery; and (d) counselor fidelity as measured by self-report and technician observations. A secondary objective of this project is to generate preliminary evidence of the impact of Learning to Breathe on self-control when compared to a control life skills condition using a comprehensive, multi-method, multi-informant self-control assessment battery.
PI: Gerald August, Ph.D.
FUNDING: University of Minnesota Grand Challenges Research Initiative
COMMUNITY PARTNERS: Community-University Health Care Center & UMN Psychiatry Outpatient Clinic
APPROACH: Demonstration Trial
This demonstration projects seeks to explore the feasibility and acceptability of a mobile application (BrainHQ) designed to (1) improve communication and decision-making between providers and clients, (2) overcome stigma and psychosocial barriers that often prevent individuals from seeking out or receiving care, (3) boost the effectiveness and efficiency of extant evidence-based services, and (4) produce health equity. The focus of this study is to assess patient and provider perceptions and attitudes regarding the utilization of technology tools. In addition, the study will investigate user tolerability, acceptability, and potential barriers of the app with the goal of informing future work in the utilization of mobile technology tools in the treatment of depression, among other mental health conditions.
PI: Meredith Gunlicks-Stoessel
FUNDING: UMN-OVPR Grant-in-Aid of Research, Artistry and Scholarship (GIA)
As an extension of the Grand Challenges Demonstration Project, Dr. Gunlicks-Stoessel is conducting a study at the University of Minnesota’s Driven to Discover facility at the Minnesota State Fair. The aims of this project are to (1) generate a normative sample of scores (via the BrainHQ app) on neurocognitive assessments of dimensions of cognitive control, and (2) examine associations between participants’ mood states and performance on measures of cognitive control. The research team successfully enrolled and collected data from approximately 370 fairgoers in the summer of 2018 and plans to do data collection again in the summer of 2019.
PI: Gerald J. August, Ph.D.
FUNDING: National Institute of Mental Health (P20MH085987; R34MH097832)
COMMUNITY PARTNER: St. Paul Youth Services
APPROACH: Adaptive-Sequential Intervention Design – applying SMART technology
This R34 study employs a SMART design to inform the construction of adaptive-sequential intervention strategies to prevent the escalation of serious conduct problems including alcohol and drug abuse among high risk youth. High risk is defined as referral for pre-court juvenile diversion services as a consequence of being ticketed by law enforcement for an offense. The experimental design features randomization to one of two first stage brief-type interventions (either youth- or parent-based). Non-responders to first stage interventions are randomized a second time to either (a) extended sessions of their first-stage intervention, or (b) switched to the alternative intervention option. The study seeks to answer tactical questions in preventive intervention such as, “What is the best first-stage intervention option”, “Which second-stage intervention option is best for youth who do not show adequate response to first stage intervention options,” and “Which sequence of intervention yields the greatest long-term benefits.” In addition, the study will explore candidate moderators (youth characteristics, i.e., executive functioning, including response inhibition, cognitive flexibility and delay of gratification) that influence a youth’s response to various interventions.
PI: Abigail Gewirtz, Ph.D.
FUNDING: National Institute of Mental Health (P20MH085987)
COMMUNITY PARTNER: State of Michigan Department of Health and Human Services (Detroit area community mental health clinics)
APPROACH: Hybrid Double Randomized Client Preference Trial
This pilot preference study involves culturally diverse children (ages 6-12) and their parents who were referred to community mental health clinics (in the greater Detroit, Michigan and surrounding communities) as the result of risk behaviors (primarily conduct problems). The study employs a parallel hybrid preference design in which participants are first randomized to either preference or no-preference arms. Those randomly assigned to the preference condition are allowed to choose among three intervention options involving different modality of delivery for the Parent Management Training-Oregon program. 1. Individual-home-based, 2. Group-clinic-based, or 3. Individual-clinic-based. A fourth group received clinic-based services as usual. Participants in the no-preference arm are randomized a second time to the one of four treatment modalities. The study assesses the relationships between pre-intervention variables: motivational cognitions (i.e., parent health beliefs, locus of control, parenting/conduct problems intervention expectancies, and parent and child desire for involvement in decision-making), family context variables (i.e., parent education, ethnicity, parent psychopathology, substance use, and child externalizing), and program preference and engagement. The goals of the study are: (a) to assess the empirical relationships between pre-intervention variables, rates of program engagement, and intervention condition (preference/no-preference). It is hypothesized that: (i) offering choice of intervention (preference condition) will result in higher levels of engagement, and (ii) that pre-intervention cognitions will moderate the relationship between preference condition and engagement. (b) To identify (in the preference group only) pre-intervention variables that are associated with preference for/selection of particular intervention options (i.e. services-as-usual, in-person group, web-based group, in-home individual parent training, or clinic-based individual parent training).
PIs: Gerald August, Ph.D
FUNDING: Center for Personalized Prevention Research in Children’s Mental Health
COMMUNITY PARTNER: Headway Emotional Health Services
APPROACH: Microtrial Design
This is study examines whether an innovative youth-focused mindfulness-based intervention (Learning to Breathe: LTB) can improve a primary intervention target, namely, emotional regulation in at risk youth who have been identified by law enforcement for commission of a minor offense and referred to a community agency for pre-court juvenile diversion services. The study further seeks to demonstrate whether improvement in emotion regulation will be associated with improvement in functional domains (i.e., academic, social) and mental health outcomes. LTB involves the deliberate training of attention to cultivate present moment awareness of emotional experience without interference from emotional reactivity. LTB may be helpful for youth who have heightened emotional reactivity and prone to act impulsively, engage in harmful risk-taking, and make irresponsible decisions.
PIs: Richard Lee, Ph.D. (UMN), Judy Ohm (Wilder Foundation)
FUNDING: Corporation for National and Community Service’s Social Innovation Fund (administered through the Twin Cities United Way)
COMMUNITY PARTNER: Amherst H. Wilder Foundation
APPROACH: Brief – Motivational Enhancement Design
This is a pilot study to identify barriers to participation in a parent training program and the cultural needs and preferences of parents. In addition, the study evaluates the feasibility of a culturally adapted version of the evidence-based Incredible Years Program (Webster-Stratton, et al. 2008). The Wilder Foundation has augmented its delivery of Incredible Years by adding a new session at the start of the program to increase parent motivation and retention. This session was developed in response to parent focus groups and pilot sessions conducted. Additionally, Wilder received funding from the Corporation for National and Community Service’s Social Innovation Fund (administered through the Twin Cities United Way) to scale-up and implement this augmented, adapted version of Incredible Years within the St. Paul Promise Neighborhood (modeled after the Harlem Children’s Zone) to Hmong and African American families. Thus far, over 60 families have completed one of three adapted versions of this parent training program. With the support of an internal grant from the University of Minnesota, the research team has completed the development and manualization of a two-session engagement module titled INTERFACE. INTERFACE expands upon the work with Wilder to augment Incredible Years with sessions to increase parent motivation and retention. The research team is conducting theater-test style focus groups with parents with children ages 2-10 and will pilot this engagement module adjoined to Incredible Years.
PI: Gerald August, Ph.D.
This pilot study will seek to optimize outcomes for adolescent drug use intervention by applying a precision-based, personalized approach. Adolescents (ages 13-17) with moderate-to-mild substance use will be randomized to either Teen Intervene, an empirically-supported brief intervention for adolescent substance use, or Skill for Success, a psychoeducational control program. Informed by recent advances in addiction research and adolescent cognitive neuroscience, the study will assess four neurocognitive processes linked to adolescent drug use: executive function, incentive salience, negative emotionality, and impulsive decision-making. We will apply both variable- and person-centered statistical analyses (a baseline target moderated mediation and an exploratory latent profile analysis) to explore whether adolescents’ neurocognitive functioning moderates treatment response to Teen Intervene. This approach will permit identification of improved intervention options and better matching of adolescents to interventions.
PI: Tim Piehler, Ph.D.
This proposed study consists of two sequential RCTs corresponding to two phases of an NIH proposal. In phase one, youth will be randomized to either the standard Learning to Breathe (LTB) program or Skills for Success (SFS), an active control condition. The first phase will establish the ability of the standard LTB intervention to impact the proposed mechanism of self-control. Furthermore, a mobile application to support the intervention will be developed during the initial phase using feedback and evaluation from participants (after study completion). After meeting Go/No-Go criteria established for phase one, the study will progress to a second RCT for phase two. The second phase will utilize an optimized version of the LTB intervention incorporating the mobile technology application to support home practice of intervention activities and generalization of skills. Participants will be randomized to a three-arm RCT, including optimized LTB, standard LTB, and the active control condition. In addition to the target mechanisms of self-control, the primary distal clinical outcome of conduct problems will be evaluated along with secondary academic and interpersonal outcomes.
PI: Gerald August, Ph.D.
This study will assess the feasibility, acceptability, and preliminary outcomes of a machine-learning based clinical decision support system for guiding treatment decisions between cognitive behavioral therapy (CBT), fluoxetine (FLX), and combination treatment (COMB) for adolescent depression. Adolescents ages 12-17 with a depression diagnosis will be recruited to participate in a 12-week randomized trial of treatment (CBT, FLX, or COMB) that is guided by the clinical decision support system (algorithm-based) or clinician’s usual approaches to decision making (treatment selection as usual). Primary outcomes are feasibility and acceptability (recruitment, retention, adherence, treatment fidelity, and treatment satisfaction). Secondary outcomes are depression, psychosocial functioning, and cost effectiveness.
PI: Jeffrey Bishop, PharmD.
This study tests a drug selection decision model based on expert consensus from the Clinical Pharmacogenetics Implementation Consortium (CPIC) of the NIH-supported Pharmacogenetics Research Network (PGRN). [The database for this consensus algorithm was extracted from the PGx literature to guide selection of commonly used antidepressant medications based on PGx factors related to drug metabolism.] This pilot study will utilize a randomized-controlled trial design to compare pharmacogenetic algorithm-guided antidepressant selection based on drug metabolism to usual care in adolescents with MDD. The primary outcome will be medication switching/discontinuation. Symptoms, side-effects, adherence and dosing will also be assessed. Participants will be randomized to receive pharmacogenetics guidance or usual care. Guidance will include the identification of drug-gene interactions to avoid, and list of alternatives for prescribers to consider after evaluating other clinical information. Additionally, clinical, cognitive, and psychosocial measures collected will be integrated into algorithm development efforts to refine pharmacogenetics decision support and identify its role in the larger precision medicine context. Finally, implementation outcomes will be examined to optimize processes for clinical translation and subsequent studies.
PI: Meredith Gulicks-Stoessel
This study will assess the feasibility, acceptability, and preliminary outcomes of psychotherapy sequences that include the three primary evidence-based components of psychosocial treatment for depression: healthy actions (behavioral activation, problem solving, called “Act”), healthy thinking (called “Think”), and healthy relationships (called “Connect”). In addition, we pilot a multi-modal assessment battery of measures of reward, problem-solving, cognitive, and interpersonal processes to explore moderators and treatment targets of the psychotherapy components. Primary outcomes are feasibility and acceptability (recruitment, retention, adherence, treatment fidelity, and treatment satisfaction). Secondary outcomes are depression and psychosocial functioning.