Notice of Availability of Administrative Supplements for Adolescent Substance Use Screening Tool Development and Validation for U.S. General Medical and Dental Settings


Notice Number: NOT-DA-12-002

Key Dates

Release Date: October 28, 2011
Receipt Date: January 06, 2012
Earliest Anticipated Start Date: March, 06, 2012

Issued by

National Institute on Drug Abuse (NIDA)
National Institute on Dental and Craniofacial Research (NIDCR)

Purpose

The National Institute on Drug Abuse, along with the National Institute on Dental and Craniofacial Research, announce an Administrative Supplement program to provide funds to supported research projects for research on adolescent substance use screening tool development and validation for U.S. general medical and dental settings.

The purpose of this Notice is to announce an administrative supplement program to support NIDA or NIDCR funded research project grants that could support research for the development and validation of tools to provide 1) a quick screen and 2) a brief assessment of substance use severity for adolescents. The tools developed should be amenable for inclusion in an electronic health record (EHR) at U.S. based general medical and dental settings. When used together, these tools will assist the clinician provider in identifying youth who either present with a substance use disorder (SUD) or is at high risk of developing a SUD. The goal is to encourage qualified investigators to form collaborations with psychometricians, substance abuse experts, developmental pediatrician/adolescent clinician/child psychiatrist researchers and research methodologists to submit proposals that validate either newly developed or adaptations of existing tools. Research proposed under this announcement must be within the scope of the funded parent research grant.

Background

Youth are not routinely screened for tobacco, alcohol or other substances at general medical and dental settings. Frequently cited obstacles to universal screening are that the existing screening instruments are not well-suited as they do not address time constraints or workflow issues at these settings. Ideally, screening tools must be brief, valid and reliable, demonstrate acceptable psychometric properties, contain developmentally appropriate screening content and language, require little or no staff training for implementation, potentially self-administered, with data entered using electronic platforms for inclusion into EHR, and be available in the public domain.

Proposed Screening Tool Requirements

The application must develop/adapt and test both a quick screen and a brief assessment tool for adoption at U.S. general medical or dental settings; and must meet the following requirements:

  • Be applicable for universal screening for youth ages 12-17 years (taking into consideration developmental risk and use prevalence differences)
  • Screen and briefly assess severity of commonly abused substances (including misuse of prescription medications and over-the-counter medications), either concurrently or in a hierarchical manner
  • Be valid for either self-administration by the adolescent or clinician/staff administration
  • Use developmentally appropriate language, be user-friendly and be meaningful
  • Demonstrate good psychometric properties for the proposed screening tools
  • Be validated against existing standardized structured interviews for SUD (e.g. Composite International Diagnostic Interview Substance Abuse Module, Diagnostic Interview Schedule for Children, Global Appraisal of Individual Need, or similar)
  • Use electronic platforms for data entry and collection
  • Factor in work flow considerations at general medical or dental settings (i.e. time constraint of a busy practice setting, staffing patterns and resources, etc.)
  • The responses provided to the screening tools (i.e. the quick screen followed by the brief assessment for those who screen positive on the quick screen) must provide information that will assist the provider in determining a) the type of substance(s) being used/misused, b) the frequency/quantity and the severity of use/misuse (i.e. determination of substance abuse/dependence or at-risk for such). [This information is key to guiding and informing the provider’s decision about how to intervene effectively to reduce/eliminate or prevent substance misuse/abuse in adolescents].
  • The final validated quick screen and the brief assessment must be made available in the public domain, to foster widespread dissemination and adoption into practice.
Budget and Funding Information

A total of $500,000 is anticipated to be provided for all projects selected through this notice in Fiscal Year 2012. Supplement requests must be less than $100,000 in direct costs, except for supplements of K awards: amount of the total funds requested on this cannot exceed the annual research funds allowed for the parent K award. In addition K award applications may not request additional salary support for the PI, but may request support for other program related expenses relating to (a) research expenses, such as supplies, equipment and technical personnel; and (b) statistical services including personnel and software/computer time up to the amount for research expenses allowed in the parent award.

Eligibility

The supplement request is for one year of funding. Applicants must hold an active grant funded by NIDA or NIDCR, under the following mechanisms: R00, R01, R34, R21, R23, R36, R37, K01, K02, K05, K08, K12, K20, K21, K23, K24, K25 and K99, U01, U18, U24, P01, P20, P30, P50 and P60) with a current project period end date of March, 2013 or later.  The parent grant must be active, and the research proposed in the supplement must be accomplished within 1 year.  Any necessary no cost extension should be in place before submission.   Before submitting a supplement application, potential applicants are highly encouraged to contact the program official of the parent grant to discuss the supplement plan and determine the responsiveness and pertinence of the potential application.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

Submitting an Administrative Supplement Request

To be considered for an administrative supplement, the request must be signed by the Authorized Organizational Representative/Signing Official (AOR/SO), and must describe the need for additional funding and the categorical costs.

Administrative supplement requests should be sent as attachments in an email, no later than 5pm (EST) on January 6, 2012, to: NIDAGMBemail@mail.nih.gov.  

Applicants who prefer to submit hard copy (paper) requests should ensure that they are received no later than 5pm (EST) on January 6, 2012. Requests to be addressed to:

NIDA Grants Management Branch
6001 Executive Boulevard
Room 4218, MSC 9560
Bethesda, MD 20892-9560, or for express delivery please use
Rockville, MD 20852

Requests should be submitted on the PHS398 Application Guide forms (font size and other formatting rules apply as designated in the instructions), as indicated below. Include only the following elements:

Cover Letter which cites this Notice, and the following information:

  • Project Director(s)/Principal Investigator(s) (PD(s)/PI(s)) name
  • Parent grant number and title
  • Amount of the requested supplement
  • Name and title of the institutional official, and
  • Phone, email, and address information for both the PD/PI and institutional official. 
  • The cover letter must be signed by the authorized organizational representative/institutional official.

PHS 398 Form Page 1 (Face page)

  • The title of the project should be the title of the parent award.
  • This Notice should be cited in Box 2, and the yes box should be checked.
  • The Principal Investigator (PI) must be the same as the PI on the parent award.  For Multiple PI parent awards, the Contact PI must be the PI listed on the supplement request, and the supplement cannot change the Multiple PI team. 
  • The remaining items on the face page should be filled out in accordance with the PHS 398 application instructions.

PHS 398 Form Page 2

  • Note: The project summary is that of the administrative supplement, not the parent grant.

A brief proposal describing the project, including:

  • Descriptions:
    • Provide a brief description of the scope of the parent project on which the supplemental request is based.
    • Include a description of the supplement's specific aims, including research design and methods and data analysis.  Describe the relationship of the supplement request to the parent grant. 
    • Describe how the requirements of the screening tools (listed above) will be met.
    • Also describe the individual ability of the research team and availability of resources to conduct the study. Budget for the supplement with a justification detailing the items requested, including Facilities and Administrative costs. Use the same budget format as the Parent Grant.
    • Research Proposal must not exceed five pages.
  • Biographical Sketch for all new key personnel (i.e. those who are additions on the supplemental project).
  • Human Subjects documentation:
    • Include a current Human Subjects/IRB approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB approvals must be in place prior to a supplement award being made. 
    • Any differences in the involvement of human subjects between the administrative supplement activity and the parent grant should be noted.
    • When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities.  Additional guidance on Human Subjects Research is provided under Part II of the PHS 398 instructions.  
  • PHS 398 Checklist Form
Selection

Administrative supplement requests will be reviewed administratively by NIH Staff. Selection factors will include the following:

  • Appropriateness of the application to the purpose of this Notice of Administrative Supplements and successfully fulfilling the screening tool requirements listed above,
  • Relevance of the proposed activities to the parent grant,
  • Adequate progress of the parent grant appropriate to the current stage of the project,
  • Inclusion of an appropriate and well-described plan to accomplish the goals within the timeframe proposed ,
  • Expertise of the research team proposed to conduct and achieve the goals the proposed supplemental study.
Inquiries

Inquiries and discussion of plans for responding to this Notice are strongly encouraged.

NIDA Contact:

Geetha Subramaniam, M.D.
Medical Officer
National Institute on Drug Abuse
6001 Executive Boulevard
Room 3173, MSC 9593
Bethesda, Maryland 20892-9593
Telephone: 301-435-0974
FAX: 301-443-6814
Email: geetha.subramaniam@nih.gov

NIDCR Contact:

David B. Clark, Dr.P.H.
National Institute of Dental and Craniofacial Research
6701 Democracy Blvd. Room 650
Bethesda, MD 20892-4878
Telephone:  301-594-4814
Email: David.Clark2@nih.gov