Transcript Aim 1. - UF Health

Grant Writing
Bill Latimer, Ph.D., M.P.H.
Professor and Chair
Clinical and Health Psychology
College of Public Health and Health Professions
University of Florida
Grants are Good
•Research Staff
•South Africa Study Staff: Tshidi Mabala, Sam Ntshegang, Bill
Latimer, Dr. Anne-Gloria Moleko, Maria More, Naomi Molfe
•Veronica Dixon (Principal, Highlandtown Middle School)
•US State Department
•Humphrey Fellowship
State Department Reception
Approach to Grant Writing
General Principles
Always be Positive
(Almost) Always Follow Your Passion
Do not Delude Yourself that Anyone Agrees with You or Your Passion
Network and Build a Team (Always ask)
No Researcher Exists on an Island (unless you exist on an island)
Get Ready for Pain and Suffering
Get Over Your Fear (and ego) and Get Brutal Internal Reviewers
Get Ready for More Pain And Suffering (i.e., revision)
Selecting an Idea
NIH Program Staff-Two Approaches:
To Consult or Not to Consult
[NIH Priorities Matter (especially now)]
Selecting a Mechanism
R01; R21; R03; K
PA vs. RFA
What All Funded Grants Had (in my opinion)
*Compelling and Clear Logic of Public Health Significance
*Compelling and Clear Logic of Innovation
*Explicit and Simple Aims with Specific Measures
*A Conceptual Model Figure
*Empirically and Conceptually Driven Hypotheses
*Preliminary Studies Tables that Support Hypotheses
*Preliminary Studies that Support Feasibility
*Study Design Figure
*Timeline Figure/Table
*Power Analyses Graphs/Figures/Tables that Inform Sample Size
*Predict and Address Limitations
Significance
• The criminal justice system is an epicenter of the US HIV
epidemic with estimates suggesting upwards of 20% of all
HIV infected adults pass through US jails and prisons each
year [5, 22-25]. A gap in the criminal justice field is
evident as reentry programs designed to prevent HIV upon
release have largely focused on inmates released from prison
and exclude the much larger population of jail arrestees [2629]. The significance of targeting arrestees is highlighted by
studies demonstrating that short-term incarcerations are
more strongly associated with elevated HIV risk behaviors
upon release than long-term incarcerations [30-32].
Innovation
The proposed study is characterized by key innovations that
have the potential to advance HIV prevention and treatment
science by developing a science-based intervention to reduce
HIV transmission fueled by drug dependent women who are
pregnant.
• Focus on drug dependent pregnant women
• Coordination of CBT and family systems approaches
• Follow-Up Assessment over 18-month period
• Biological assessment of HIV and STIs
• Collaboration with CAP
Simple Aims with Specific Measures
• Aim 1.To evaluate the separate and possibly synergistic effects of
Family Management and Teen Achievement Interventions on postintervention drug use, problem behavior, psychological distress, and
academic achievement of indicated adolescents.
• Aim 2.To examine mediated outcome pathways whereby skills (e.g.,
learning skills) and behavior change processes (e.g., adaptive family
communication) targeted by the family and teen interventions result in
successful outcomes.
• Aim 3.To evaluate the degree to which intervention effects vary as a
function of pretreatment client characteristics on neurocognitive,
internalizing/externalizing, and demographic factors to discern for
whom family and teen interventions work best.
•Conceptual Model of Integrated Family and Cognitive-Behavioral Therapy
•IFCBT
•Individual
•Therapy:
Executive
•Function-Type
•Skills Informed
•by NP Assess.
•Group Therapy:
Rational
Emotive Therapy
Problem
Solving Therapy
•Couples/Family
•Therapy:
•Structural &
•Strategic
•Therapies
•
Drug Abuse and Infectious
Disease Risk Factors across
Multiple Ecological Systems
•Poor Health Care Access
•Deviant Social
Networks
•Family Pathology
•Partner Conflict
•Individual
Factors:
Neurocognitive
•Deficits
Irrational Beliefs
Alcohol/Illicit
Drug Use
Psychiatric
Comorbidity
Sexual Risk
Behavior
•
•Protective Factors
•Targeted by IFCBT
•Executive
•Function-Type
Skills:
Planning
Decision Making
Predicting
Evaluation
Impulse Control
Integration
•Cognitive Skills
Fostered by Group
Therapy:
Awareness of
•Irrational Beliefs
Rational Beliefs
Problem Solving
Skills
•Social Support:
Group Members
Intimate Partner
Family Members
• IFCBT Targeted Outcomes
•Direct:
•Direct and
•Mediated:
Psychological
Well-Being
Reduced
Sexual Risk
Behavior
Social Support
Health Care
and Self Help
Access
Drug
Abstinence
No
Infectious
Disease
Transmission
/Acquisition
What All Funded Grants Had (in my opinion)
*Preliminary Studies Tables that Support Hypotheses
*Preliminary Studies that Support Feasibility
We conducted a pilot test and the proposed study
site. Among the 200 drug users approached to
enroll in the study 196 provided consent (x%).
Among the 196 who provided consent 172
completed the baseline assessment (x%). Among
the 172 who completed the baseline assessment 145
completed more than 70% of the intervention and
162 completed more than 50% of the intervention.
Of the 172 who completed the baseline assessment
and attended 1 or more intervention sessions, 153
completed the 3-month follow-up assessment.
*Timeline Figure/Table
*Power Analyses Graphs/Figures/Tables that Inform Sample Size
*Predict and Address Limitations
Study Limitations and Offsetting Strengths. As in any randomized prevention trial,
our proposed study will face a number of challenges to its design and feasibility. To
meet challenges associated with participant recruitment, we will …Non-compliance
can also be a serious form of bias in prevention trials. To meet challenges
associated with compliance…. Differential follow-up can also be a serious form of
bias in prospective studies of at-risk populations. Well-tested follow-up procedures
will be used to…We also recognize that the feasibility of administering the total
number of planned assessments may be questioned. To meet this challenge, the
timing of the baseline, process, and outcome assessments have been organized to
ensure…Throughout the proposal, we have also sought to reduce or eliminate other
sources of potential bias. For example…In addition, we recognize the challenge
associated with administering a 2.5-hour battery of neuropsychological tests and
self-report tools to at-risk youth at the baseline and 12-month assessment points.
We hope to successfully meet this challenge through…The sample will also not be
fully representative of minority groups. However, an off-setting strength of the
study is its anticipated equal representation of both genders and of African American
and White adolescents thereby allowing for comparisons between these groups.
Research Plan Section
Approach (Example)
• D2. Interventions
• D2.1. Family Management Intervention (FMI).
– A. Parent Focus Curriculum
– B. Brief Family Intervention
• D2.2. Teen Achievement Intervention.
– A. Teen Achievement Curriculum
– B. Reciprocal Peer Tutoring
• D2.3. Self-Change Control Condition.
Research Plan Section
Approach (Example)
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D3. Measures
D3.1. Intervention Fidelity Variables
D3.2. Drug Abuse Risk and Protective Factors
D3.3. Cognitive Functions.
D3.4. Process Measures.
D3.5. Outcome Measures.
Research Plan Section
Approach (Example)
• D4. Study Hypotheses Informed by Ecological
Theory and Empirical Findings.
• Aim 1. To evaluate the separate and possibly synergistic
effects of Family Management and Teen Achievement
Interventions on post-intervention drug use, problem
behavior, psychological distress, and academic achievement
of indicated adolescents.
• Aim 2. To elucidate mediated outcome pathways whereby
skills (e.g., learning skills) and behavior change processes
(e.g., adaptive family communication) targeted by the family
and teen interventions result in successful outcomes.
• Aim 3. To evaluate moderated intervention outcomes by
pretreatment client characteristics.
Research Plan Section
Approach (Example)
• D5. Instruments
• D5.1. Intervention Fidelity and Clinical Change
Tools Completed by Trained Raters.
• D5.2. Tools for Parents and Adolescents.
• D5.3. Tools for Parents and Teachers.
• D5.4. Tools for Adolescents Only.
• D5.5. Neuropsychological Assessment Battery for
Adolescents.
• D5.6. Tools for Parents Only.
• D5.7. School Records and Standardized
Achievement Test Scores.
Research Plan Section
Approach (Example)
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D6. Intervention Fidelity.
D6.1. Clinician Training Protocol.
D6.2 Ongoing Evaluation of Intervention Fidelity.
D7. Baseline Sample Size Needed To Obtain
Sufficient Power At Follow-Up Allowing For
Attrition.
D8. Study Population.
D9. Middle School Study Sites:
D10. Recruitment Procedures:
D11. Intervention Delivery.
Research Plan Section
Approach (Example)
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D12. Data Collection:
D12.1. Baseline Assessment.
D12.2. Process Assessment.
D12.3. Outcome Assessment.
D13. Data Analysis Plan.
D14. Preliminary Analyses.
D14.1. Coding Session Videotapes to Derive
Clinical Change Process Measures
• D14.2. Controlling for Possible Clinician Effects.
• D14.3. Controlling for Possible School Cohort
Effects.
Research Plan Section
Approach (Example)
• D14.4. Controlling for Possible Client Intake
Problem Severity Between Groups
• D15. Data Analysis Plan to Address Study Aims
• Aim 1. Direct Effects of Family Management and Teen
Achievement Interventions.
– Aim 1.1. Intervention Effects on Continuous Outcomes.
– Aim 1.2. Intervention Effects on Time-to-Event
Outcomes.
– Aim 1.3. Intervention Effects on Targeted Change
Processes.
– Aim 1.4. Intervention Effects on Skill Acquisition and
Problem Behavior Trajectories.
Research Plan Section
Approach (Example)
• Aim 2. Effect-Mediation
– Aim 2.1. Mediated Intervention Outcomes.
– Aim 2.2. Intervention Effects on Distal Outcomes
Through Skill Acquisition Trajectories.
– Aim 2.3. Client Group Involvement Effects on Outcome.
• Aim 3. Effect-Modification.
– Aim 3.1. To Identify For Whom Interventions Work
Best.
– Aim 3.2. Evaluate Non-Compliance Effects.
• D16. Study Limitations and Offsetting Strengths.
Other Stuff
Early Career Investigator
New Investigator
Supplements
Special Mechanisms
Other Stuff
Introduce Your Team
Consultants
Letters
Bios
Budget Justification
Other Stuff
Early Career Investigator
New Investigator
Supplements
Special Mechanisms
Other Stuff
Early Career Investigator
New Investigator
Supplements
Special Mechanisms
Thank you!