Opportunity Information: Apply for W81XWH 15 ARP CTA

  • The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD FY15 Autism Clinical Trial Award" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420 Military Medical Research and Development.
  • This funding opportunity was created on Apr 17, 2015 and posted on Apr 17, 2015.
  • Applicants must submit their applications by Oct 1, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $3,200,000.00 to eligible and selected applicants.
  • The number of recipients for this funding is limited to 2 candidate(s).
  • Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.
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Opportunity Summary:

The DoD FY15 Autism Clinical Trial Award (Funding Opportunity Number W81XWH-15-ARP-CTA) is a Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA) funding opportunity under the Autism Research Program (ARP) designed specifically to support clinical trials that could meaningfully improve the treatment or day-to-day management of autism spectrum disorder (ASD). The core intent is to move beyond exploratory or preclinical work and directly fund human clinical research with practical, measurable impact for individuals with ASD and their families. Because it is a clinical trial award, proposed projects must include a clinical trial component, and the funds cannot be used for preclinical studies.

The program invites applications from across the clinical research landscape and places special emphasis on projects that address high-priority needs in the ASD community. Target areas include behavioral, cognitive, and other non-pharmacological therapies; pharmacological treatments either for autism broadly or for clearly defined subgroups within autism; and dissemination and implementation research focused on getting proven behavioral interventions into real-world settings. For implementation-focused proposals, the opportunity highlights the importance of measuring both fidelity (whether the intervention is delivered as intended) and outcomes (whether it actually helps in practice). Another major area of interest is therapies aimed at reducing or managing conditions that commonly co-occur with ASD, such as sleep disturbances, gastrointestinal problems, aggression, depression, and anxiety. Overall, the DoD frames this award as supporting research with the potential for a major impact, meaning the work should be positioned to change clinical practice, improve functioning, reduce symptom burden, or otherwise lead to tangible improvements in quality of life.

From an administrative and funding standpoint, this is a discretionary opportunity offered as a Grant or Cooperative Agreement within the Science and Technology and other Research and Development category. The posting date was April 17, 2015, with an application closing date of October 1, 2015, and an archive date of October 31, 2015. The opportunity anticipated making about two awards, with an estimated total funding level of $3,200,000. The CFDA listing associated with it is 12.420 (Military Medical Research and Development). Cost sharing or matching is not required, which can reduce barriers for applicants who may not have additional institutional funds to contribute.

Eligibility is described as unrestricted, meaning it is broadly open to applicants of any entity type, subject to any clarifications that may appear in the full announcement under an “Additional Information on Eligibility” section. For applicants who had trouble accessing the full announcement, the listed point of contact is the CDMRP Help Desk at 301-682-5507.

DoD FY15 Autism Clinical Trial Award (W81XWH-15-ARP-CTA) FAQs

1) What is the DoD FY15 Autism Clinical Trial Award?

The DoD FY15 Autism Clinical Trial Award is a funding opportunity under the Autism Research Program (ARP), managed by the Department of the Army through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is designed specifically to support clinical trials that could meaningfully improve the treatment or day-to-day management of autism spectrum disorder (ASD).

2) What is the main purpose of this award?

The core intent is to fund human clinical research with practical, measurable impact for individuals with ASD and their families. The program emphasizes projects positioned to improve clinical practice, functioning, symptom burden, or quality of life in tangible ways.

3) Is a clinical trial required?

Yes. Because this is a Clinical Trial Award, proposed projects must include a clinical trial component.

4) Can the award be used for preclinical or exploratory studies?

No. The opportunity is intended to move beyond exploratory or preclinical work. Funds cannot be used for preclinical studies.

5) What kinds of interventions or research areas are encouraged?

The opportunity emphasizes high-priority needs in the ASD community, including:

  • Behavioral, cognitive, and other non-pharmacological therapies
  • Pharmacological treatments for autism broadly or for clearly defined subgroups within autism
  • Dissemination and implementation research focused on getting proven behavioral interventions into real-world settings
  • Therapies aimed at reducing or managing commonly co-occurring conditions (comorbidities) associated with ASD

6) Does the program support both pharmacological and non-pharmacological clinical trials?

Yes. The target areas explicitly include both non-pharmacological therapies (behavioral, cognitive, and other non-pharmacological approaches) and pharmacological treatments.

7) Are trials focused on specific subgroups within autism allowed?

Yes. Pharmacological treatments may be proposed either for autism broadly or for clearly defined subgroups within autism.

8) What is meant by dissemination and implementation research in this opportunity?

Dissemination and implementation research, as described in the opportunity, focuses on getting proven behavioral interventions into real-world settings (not just controlled research environments).

9) Are there specific measurement expectations for implementation-focused projects?

Yes. For implementation-focused proposals, the opportunity highlights the importance of measuring both:

  • Fidelity: whether the intervention is delivered as intended
  • Outcomes: whether the intervention helps in practice

10) Does the award support clinical trials targeting co-occurring conditions with ASD?

Yes. A major area of interest includes therapies aimed at reducing or managing conditions that commonly co-occur with ASD.

11) Which co-occurring conditions are specifically mentioned?

The opportunity specifically mentions sleep disturbances, gastrointestinal problems, aggression, depression, and anxiety as examples of co-occurring conditions of interest.

12) What does the DoD mean by "major impact" for this award?

The award is framed as supporting research with the potential for a major impact, meaning the work should be positioned to change clinical practice, improve functioning, reduce symptom burden, or otherwise lead to tangible improvements in quality of life.

13) What is the Funding Opportunity Number (FON) for this program?

The Funding Opportunity Number is W81XWH-15-ARP-CTA.

14) Which agency and program are associated with this opportunity?

This opportunity is associated with the Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), and it is offered under the Autism Research Program (ARP).

15) What type of funding instrument is used?

The opportunity is offered as a Grant or Cooperative Agreement.

16) What is the assistance listing (CFDA) number associated with this opportunity?

The CFDA listing associated with this opportunity is 12.420 (Military Medical Research and Development).

17) What category is this opportunity listed under?

The opportunity is listed under the Science and Technology and other Research and Development category.

18) Is cost sharing or matching required?

No. Cost sharing or matching is not required.

19) Who is eligible to apply?

Eligibility is described as unrestricted, meaning it is broadly open to applicants of any entity type, subject to any clarifications that may appear in the full announcement under an "Additional Information on Eligibility" section.

20) How many awards were anticipated, and what was the estimated total funding level?

The opportunity anticipated making about two awards, with an estimated total funding level of $3,200,000.

21) When was the opportunity posted, and what were the key dates?

The posting date was April 17, 2015. The application closing date was October 1, 2015, and the archive date was October 31, 2015.

22) Who can applicants contact if they have trouble accessing the full announcement?

Applicants who had trouble accessing the full announcement were directed to contact the CDMRP Help Desk at 301-682-5507.

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