Notice Number: NOT-MH-08-020

Key Dates
Release Date: September 8, 2008

Issued by
National Institute of Mental Health (NIMH) (http://www.nimh.nih.gov)

The purpose of this Notice is to provide clarification of the research objectives of PAR-06-248  “From Intervention Development to Services:  Exploratory Research Grants (R34).”  This funding opportunity announcement (FOA) is intended to encourage research on: 1) the development and/or pilot testing of new or adapted interventions; 2) pilot testing interventions with demonstrated efficacy in broader scale effectiveness trials; or 3) innovative services research directions that require preliminary testing or development. This FOA seeks to encourage applications that will provide resources for evaluating the feasibility, tolerability, acceptability, and preliminary safety of novel approaches to improving mental health and modifying health risk behavior, and for obtaining the preliminary data needed as a pre-requisite to a larger-scale intervention (efficacy or effectiveness) or services study.   

Investigators have often used the R34 mechanism to go beyond the goals of examining feasibility, safety, acceptability, and tolerability. Although collection of preliminary data regarding these parameters is advised, attempting to obtain an estimate of an effect size is not an intended outcome. The variability in the effect sizes obtained, given the limited sample sizes typically supportable under this mechanism, is often so large as to be unreliable. Using these potentially unstable effect size estimates in power calculations for larger studies, without regard to clinical meaningfulness, is not advisable.

Intervention studies submitted in response to PAR-06-248 do not necessarily need to be scaled down Randomized Controlled Trials (RCTs) that propose formal tests of intervention outcomes, but rather should propose the developmental work to be performed that would enhance the probability of success in a larger trial. This is best done by working out the details of the experimental protocol (including the assessment protocol, the experimental intervention protocol, the comparison intervention protocol, and randomization procedures, if appropriate), examining feasibility of recruiting patients into the study conditions (including the experimental condition(s) and the comparison condition, if relevant), and developing supportive materials and resources.

Services studies that propose non-RCT designs do not need to be a reduced scope version of a planned larger study, but should instead attempt to develop and refine the research tactics to be utilized in the more definitive study.

Inquiries

For further information please contact:
 
Joel Sherrill, Ph.D.
Division of Services and Intervention Research
National Institute of Mental Health
6001 Executive Boulevard, Room 7145, MSC 9633
Bethesda, MD  20892-9633
Telephone:  (301) 443-2477
FAX:  (301) 594-6784
Email: [email protected]