Notice Number: NOT-MH-18-001
Key Dates
Release Date: October 12, 2017
PA-16-287
Issued by
National Institute of Mental Health (NIMH)
Purpose
Universal screening for autism spectrum disorder (ASD) is one approach to achieving early diagnosis and engagement in treatment among children. In 2016 the U.S. Preventive Services Task Force (USPSTF) released its recommendations on early universal ASD screening and concluded that more research is needed “to assess the balance of benefits and harms of screening for ASD in young children for whom no concerns of ASD have been raised by their parents or a clinician.” NIMH is interested in collecting data from currently funded studies that are relevant to the Task Force recommendations.
The purpose of this notice is to encourage submissions for administrative supplement requests to PA-16-287 from investigators with relevant active National Institute of Mental Health (NIMH) supported research project grants to assess the effectiveness of early screening and engagement in services among young children with ASD. In addition to remaining within the scope of the parent awards, administrative supplement requests are intended to support research activities that focus on:
- Measurement of short-term and intermediate risks and benefits of early ASD screening
- Preliminary validation of broadband screening instruments testing young children at age 12 months
Submissions Requested
NIMH is encouraging submissions for administrative supplement requests to address two specific areas of research: (1) Measurement of short-term and intermediate risks and benefits of early ASD screening; and (2) Preliminary validation of broadband screening instruments testing young children at age 12 months. Submissions focusing on research area (1) should address both sub-components (1a and 1b) listed below. Applicants focusing on research area (2) should submit a separate administrative supplement request. Applicants who wish to apply to both areas (1) and (2) must
submit separate submissions for administrative supplement requests.
(1) Measurement of short-term and intermediate risks and benefits of early ASD screening
(a) Identify and track children who initially screened positive for ASD risk yet did not receive a subsequent diagnosis of ASD (“false positive”). Applicants may also collect data on children who initially screened negative for ASD risk, yet subsequently received an ASD diagnosis (“false negative”). Data to be collected and analyzed will include the extent of subsequent diagnoses for other disorders, and time to and receipt of interventions or treatments for ASD or other disorders between the initial screening and the diagnosis or after diagnosis. Of primary interest are the benefits and adverse consequences of screening for ASD at ages 12-18 months; and
(b) Measure the frequency of parent and/or provider concern among children aged 12-18 months who are screened, diagnosed or receiving interventions for ASD, and measure the impact of parental concern and treatment provider concern, or lack of concern, on timing of screening, length of interval between screening and diagnosis, outcome of diagnosis, receipt of ASD treatment or services. Follow-up data to be collected would assess the impact of parental and/or provider concern on intermediate and longer term risks, benefits and outcomes for children and families.
(2) Preliminary validation of broadband screening instruments testing young children at age 12 months
For studies that are currently conducting ASD screening of children between 16-18-months, submissions are invited to conduct preliminary validation and testing of psychometric properties for broadband screening instruments with children who are age 12 months.
While remaining within the scope of the parent grant, the proposed requests must include a detailed description of the proposed activities, not to exceed 18 months; and be supported by adequate progress to date by the parent study, including meeting enrollment milestones. Important aspects to be considered in the proposed requests include the anticipated number of data points that can be captured via the proposed supplemental activities, and the plan for additional analyses using the data that will be collected under the supplement.
The project and budget period of the supplement must be within the currently approved project period for the existing parent award. Submissions that entail collaboration with autism researchers from other academic institutions are strongly encouraged.
Eligibility Requirements
In order to quickly collect relevant research in response to the USPSTF recommendation statement in 2016, priority will be given to NIMH R01 projects that will be completed by or before 2020.
- Submissions will be restricted to currently funded, ongoing projects that are screening young children ages 12-18 months in population-based studies.
- All applicants must be currently in compliance with the NIMH Recruitment Milestone Report (RMR) requirements.
- Studies utilizing screening instruments with clinical populations and with high-risk sibling populations will not be eligible.
Budget and Available Funds
The budget for each supplement is limited to $150,000 in direct costs and should reflect the actual needs of the proposed projects and be reasonable with respect to the activities proposed. All program-related expenses must be justified as specifically required by the proposed activities and must not duplicate items generally available from other sources at the applicant or collaborating institutions.
Highest priority for funding consideration will be given to submissions that entail collaboration with autism investigators from other academic institutions.
Submitting a Request
Prospective applicants should follow the instructions in Section IV in PA-16-287: Administrative Supplements to Existing NIH Grants and Cooperative Agreements. NIMH will only consider submissions in which the Research Strategy section does not exceed 6 pages.
All applicants are encouraged to discuss potential requests with their program official. Additionally, prior to submission, applicants should review NIMH's website to ensure they meet the Institute's requirements.
This Notice is a one-time announcement and submissions are due by 5:00 PM local time on December 15, 2017. Please include this notice number (NOT-MH-18-001) in the title.
Submission Review
Submissions will be reviewed as described in Section V in PA-16-287: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (https://grants.nih.gov/grants/guide/pa-files/PA-16-287.html).
Inquiries
Please direct all inquiries to:
Denise Pintello, Ph.D., M.S.W.
National Institute of Mental Health (NIMH)
Telephone: 301-451-1481
Email: [email protected]
and Human Services (HHS)
