CDC-RFA-DD19-1901.pdf

Centers for Disease Control

National Center on Birth Defects and Developmental Disabilities

Enhancing Public Health Surveillance of Autism Spectrum Disorder through the Autism and

Developmental Disabilities Monitoring (ADDM) Network

CDC-RFA-DD19-1901

Application Due Date: 10/01/2018

Enhancing Public Health Surveillance of Autism Spectrum Disorder through the Autism and

Developmental Disabilities Monitoring (ADDM) Network

CDC-RFA-DD19-1901

TABLE OF CONTENTS

Part I. Overview Information A. Federal Agency Name B. Funding Opportunity Title C. Announcement Type D. Agency Funding Opportunity Number E. Assistance Listings (CFDA) Number F. Dates G. Executive Summary

Part II. Full Text A. Funding Opportunity Description B. Award Information C. Eligibility Information D. Application and Submission Information E. Review and Selection Process F. Award Administration Information G. Agency Contacts H. Other Information I. Glossary

Part I. Overview Information Applicants must go to the synopsis page of this announcement at www.grants.gov and click on the "Send Me Change Notifications Emails" link to ensure they receive notifications of any changes to CDC-RFA-DD19-1901. Applicants also must provide an e-mail address to www.grants.gov to receive notifications of changes.

A. Federal Agency Name:

Centers for Disease Control and Prevention (CDC) / Agency for Toxic Substances and Disease Registry (ATSDR) B. Notice of Funding Opportunity (NOFO) Title:

Enhancing Public Health Surveillance of Autism Spectrum Disorder through the Autism and Developmental Disabilities Monitoring (ADDM) Network C. Announcement Type: New - Type 1 This announcement is only for non-research activities supported by CDC. If research is proposed, the application will not be considered. For this purpose, research is defined at https ://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf.

Guidance on how CDC interprets the definition of research in the context of public health can be found at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (See section 45 CFR 46.102(d)).

D. Agency Notice of Funding Opportunity Number:

CDC-RFA-DD19-1901

E. Assistance Listings (CFDA) Number:

93.998 F. Dates:

1. Due Date for Letter of Intent (LOI): 08/17/2018

2. Due Date for Applications: 10/01/2018, 11:59 p.m. U.S. Eastern

Standard Time, at www.grants.gov.

3. Date for Informational Conference Call:

An informational call for potential applicants will take place on August 16, 2018, at 1:00pm Eastern Time, Toll-Free Number: 855-644-0229, Conference ID: 8547938

G. Executive Summary:

1. Summary Paragraph:

The purpose of this NOFO is to enhance the capacity of surveillance programs to implement a population-based, multiple source surveillance program for autism spectrum disorder (ASD).

The project will fund sites to participate in the Autism and Developmental Disabilities Monitoring (ADDM) Network and will enhance surveillance activities at both prior and newly participating sites through two funding components. Component A is required for all applicants, while applying for Component B funding is optional. Component A funds surveillance of autism spectrum disorder (ASD) among 4-year-old and 8-year-old children. Component A activities include: adhere to standardized ADDM Network methodology; renew or establish agreements for access to BOTH health and education data sources (electronic and paper https://www.grants.gov https://www.grants.gov https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.gpo.gov/fdsys/pkg/CFR-2007-title42-vol1/pdf/CFR-2007-title42-vol1-sec52-2.pdf https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html https://www.grants.gov records); staff training and continued education; report clean, de-identified data with vital records/census linkages to CDC; submit at least two manuscripts; engage partners and stakeholders in activities aimed at increasing use of ADDM data; and create and implement a strategic plan for performance monitoring and evaluation. Component B funds conducting follow-up at age 16 years of children abstracted for ASD at age 8 years in 2010 and 2012, including collecting data on characteristics, functioning, and educational service delivery (including transition planning). These data will inform public health strategies to improve identification and services for children with ASD.

a. Eligible Applicants: Open Competition

b. NOFO Type: Cooperative Agreement

c. Approximate Number of Awards: 10 Up to 10 Component A awards and up to 2 Component B awards. Only applications that are funded under Component A will be considered for Component B funding.

d. Total Period of Performance Funding: $20,400,000

e. Average One Year Award Amount: $600,000 Ceiling: Component A: $625,000; Component B (optional):$150,000 Average: Component A: $600,000; Component B (optional):$125,000 Floor: Component A: $525,000

f. Total Period of Performance Length: 4

g. Estimated Award Date: 01/01/2019

h. Cost Sharing and / or Matching Requirements: N Cost sharing or matching funds are not required for this program. Although no statutory matching requirement for this NOFO exists, leveraging other resources and related ongoing efforts to promote sustainability is strongly encouraged.

Part II. Full Text A. Funding Opportunity Description

Part II. Full Text

1. Background

a. Overview Since the early 1990s, the number of children identified with autism spectrum disorder (ASD) has risen markedly. The uncertainty regarding the causes of this increase and the need for medical and educational services among this population has created a substantial level of concern among stakeholders and the general public. Since 2000, the ADDM Network has conducted ongoing surveillance of ASD prevalence and characteristics based on expert review of children’s health and education records, a validated, feasible method of population-based ASD surveillance. Monitoring ASD among successive birth cohorts in the ADDM Network provides critical information to monitor trends and disparities in prevalence, plan services and allocate resources, improve early identification of ASD, and suggest areas for further research.

Key information reported by the ADDM Network includes, a rise in documented ASD prevalence based on a consistent methodology over time, a decrease in the proportion of children with ASD who also have intellectual disability, and little evidence of a decrease in the age at ASD evaluation and diagnosis.

Through 2014, the ASD surveillance case definition was based on diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV- TR). Beginning in surveillance year 2014, a new surveillance case definition incorporated the revised DSM-5 diagnostic criteria, allowing for a comparison of ASD prevalence and characteristics based on the old and new surveillance case definitions in 2014 and 2016. Since the long-term effect of this change is not yet known, it is important to continue to monitor the prevalence and characteristics of ASD based on the new case definition moving forward.

ADDM Network ASD surveillance has been conducted among children aged 8 years since 2000, and surveillance among children aged 4 years in selected sites was added in 2010. ASD surveillance based on review of health and education records may be more complete among 8-year-old than 4-year-old children. Other co-occurring developmental disabilities (DDs) such as intellectual disability, an important indicator of functional level among children with ASD, can also be reliably assessed among 8-year-olds. ASD surveillance among 4-year-old children may provide timely information on evaluation and diagnostic patterns that can inform public health strategies to improve early identification of ASD. In addition, ASD surveillance among 4-year-old children can be linked to subsequent ASD surveillance among 8-year-old children to allow for comparisons of ASD prevalence and characteristics at different ages among children in a single birth cohort. Previous ADDM data suggest that access to children’s education records is essential to ensure complete ascertainment of children with ASD as well as obtain information on intellectual ability.

ASD stakeholders show substantial interest in obtaining more information on the characteristics of ASD among adolescents, including services related to the transition to adulthood. Transition planning for adulthood is crucial for ensuring that children with ASD reach their developmental potential and receive appropriate educational, vocational, and residential services to allow integration into their communities. Monitoring 16-year-old children with ASD can provide valuable information on transition planning in special education services, the planned trajectory for the immediate post-high school years, and detailed population-based data on the phenotype of ASD in adolescence.

b. Statutory Authorities Sections 301(a) and 317C of the Public Health Service Act, as amended [42 U.S.C. §§ 241(a) and 247b-4, as amended].

c. Healthy People 2020 N/A

d. Other National Public Health Priorities and Strategies

Data from the ADDM Network are used to inform the strategic planning of the Interagency Autism Coordinating Committee (IACC, http://iacc.hhs.gov/index.shtml), a Federal advisory committee charged with coordinating work regarding autism spectrum disorder (ASD) across federal agencies.

e. Relevant Work This is the fifth funding cycle announcement for the ADDM Network, which CDC has funded since 2000 (http://www.cdc.gov/ncbddd/autism/addm.html). Estimates of ASD prevalence and characteristics have been reported biennially for 2000-2014, in addition to dozens of scientific publications from analyses of characteristics of children with ASD. Specific focus areas have included time trends in ASD prevalence and a comparison of prevalence and characteristics based on updated surveillance case criteria aligned with current ASD diagnostic criteria.

Community education and outreach activities aim to foster activities to increase ASD awareness and reduce barriers to ASD identification.

2. CDC Project Description

a. Approach

Bold indicates period of performance outcome.

CDC-RFA-DD19-1901

Logic Model: Enhancing Public Health Surveillance of Autism Spectrum Disorder through the Autism and Developmental Disabilities Monitoring (ADDM) Network

Strategies and Activities Short-Term Outcomes Intermediate Outcomes

Long-Term Outcomes

S1: Component A (4 and 8-year-old ASD surveillance) A1: Adhere to standardized ADDM network methodology A2: Renew or establish agreements for requests for and access to BOTH health and education data sources A3: Staff training and continued education A4: Report clean, de-identified data w/linkages to

CDC

OC1: Improved understanding of ASD, including trends & disparities in ASD prevalence over time and by demographic factors OC2: Strengthened ASD surveillance among 4-year-old children OC3: Improved understanding of differences in ASD characteristics by age OC4: Stronger

OC7: Increased contribution of ADDM data to the scientific understanding of

ASD

OC8: Increased contribution of ADDM data to improving early identification of ASD

OC9: Decreased disparities in ASD identification and service delivery OC10: Decreased age of ASD identification OC11: Improved policies & plans that address ASD research agendas & services for children with ASD http://iacc.hhs.gov/index.shtml http://www.cdc.gov/ncbddd/autism/addm.html relationships between recipient and partners/ data sources OC5: Increased dissemination of ADDM data OC6: Improved reliability & efficiency of ADDM surveillance

S2: COMPONENT B

(optional) 16-year-old ASD

SURVEILLANCE

A5: Conduct follow-up at age 16 years of children abstracted for ASD at age 8 years in 2010, collecting data on behavioral characteristics, associated features, test scores, and educational service delivery (including transition planning)

S3: SITE-INITIATED

ANALYSES

A6: Submit at least two manuscripts based on analyses in two of three topic areas

1. Use a variety of state-level administrative data to estimate an administrative ASD prevalence among children aged 0-21 years

2. Compare characteristics of children with ASD identified at different ages

3. Conduct analyses of disparities by sociodemographic factors for outcomes of interest (e.g.

prevalence, age at identification)

S4: COMMUNITY

EDUCATION &

OUTREACH

A7: Engage partners and stakeholders in activities aimed at increasing practical use of ADDM Network data, including addressing gaps in ASD identification and service delivery, particularly in underserved populations

S5:

MONITORING/EVALUA

TION

A8: Create & implement a strategic plan A9: Complete a site evaluation plan A10: Conduct ongoing quality assurance & control activities (QA/QC)

i. Purpose The purpose of this Notice of Funding Opportunity is to develop and enhance the capacity of programs to implement a population-based, multiple-source surveillance program for autism spectrum disorder (ASD) in order to provide estimates of the prevalence and characteristics of children with ASD, track prevalence and characteristics over time, monitor disparities by race/ethnicity and socioeconomic status, suggest areas for future research, and provide data to inform planning for resource and service needs and guide public health programs to promote ASD identification as early as possible.

ii. Outcomes ADDM Network sites are expected to demonstrate measurable progress toward addressing short- and intermediate-term outcomes depicted in the logic model.

The short term and intermediate outcomes for Components A and B include the following:

Outcome 1 (OC1): Improved understanding of ASD, including trends and disparities in ASD prevalence over time and by demographic factors (e.g., sex, race/ethnicity, rural/urban).

Outcome 2 (OC2): Strengthened ASD surveillance among 4-year-old children through collection of ADDM data for 4-year-olds in all sites.

Outcome 3 (OC3): Improved understanding of differences in ASD characteristics by age through comparisons of children aged 4 years, 8 years, and 16 years.

Outcome 4 (OC4): Stronger relationships between recipient and partners/data sources through community events and data sharing.

Outcome 5 (OC5): Increased dissemination of ADDM data through presentations, publications, online communications, and community events.

Outcome 6 (OC6): Improved reliability and efficiency of ADDM surveillance through adherence to standardized data collection methods, assessment of performance measures, ongoing training, and sharing of best practices among sites.

The long term outcome for Component A and B includes:

Outcome 11 (OC11): Improved policies and plans that address ASD research agendas and services for children with ASD.

iii. Strategies and Activities Applicants must select Component A (Strategy 1) or both Component A (Strategy 1: 4-year-old and 8-year-old ASD Surveillance) and the optional Component B (Strategy 2: 16-year-old ASD Surveillance). All applicants are responsible for addressing Strategies 3 (Site-initiated analyses), 4 (Community education and outreach), and 5 (Monitoring/Evaluation). The outcomes to be achieved during the period of performance will be the result of the following strategies and activities:

Strategy 1 (S1): [Component A] – 4-year-old and 8-year-old ASD Surveillance Applicants must address the following activities in their application:

Activity 1 (A1): Adhere to standardized ADDM methodology & case definitions

ADDM Network Surveillance Methodology and Case Definitions – Applicants must describe the surveillance methodology they plan to use for their proposed project site. It is the responsibility of each recipient in the ADDM Network to conduct surveillance of autism spectrum disorder (ASD) using a common methodology modeled after the Metropolitan Atlanta Developmental Disabilities Surveillance Program (MADDSP) (Rice CE, Baio J, Van Naarden Braun K, et al. A public health collaboration for the surveillance of autism spectrum disorders. Paediatric Perinat Epi 2007; 21: 179-90. Yeargin-Allsopp M, Rice C, Karapurkar T, Doernberg N, Boyle C, Murphy C. Prevalence of autism in a US metropolitan area. JAMA 2003; 289: 49-55).

ADDM is an active surveillance system that does not rely solely on professional or family reporting of an existing diagnosis or classification to ascertain ASD case status. Case determination is completed in two phases. The first phase involves screening and abstraction of records at multiple data sources in the community. All abstracted evaluations then are compiled and reviewed by trained clinicians to determine ASD case status in the second phase of the study. In the first phase, a broad net is cast to screen thousands of records and identify a subset of children with general symptoms of ASD, whereas a much more strict case definition is applied during the second phase of the study.

Because children’s records are screened at multiple data sources, developmental assessments completed by a wide range of health and education providers are included. Data sources are categorized as either 1) education source type, including evaluations to determine eligibility for special education services or 2) health source type, including diagnostic and developmental assessments from psychologists, neurologists, developmental pediatricians, physical therapists, occupational therapists, speech/language pathologists, and other providers. When possible, agreements to access records are made at the institutional level in the form of contracts, memoranda, or other formal agreements. In rare cases, permission to access children's records may be based on parent or guardian consent; however, using individual consent for public health surveillance may introduce bias into prevalence estimates.

In the first phase of ADDM surveillance, ADDM Network sites identify source records to review based on a child’s year of birth and either 1) eligibility classifications in special education or 2) International Classification of Diseases, Ninth (ICD-9) or Tenth (ICD-10) Revision billing codes for select childhood disabilities or psychological conditions. Children’s records are screened to confirm year of birth and residency in the surveillance area at some time during the surveillance year. For children meeting age and residency requirements, the source files are screened for certain behavioral or diagnostic descriptions defined by ADDM as “triggers” for abstraction (e.g., child does not initiate interactions with others, prefers to play alone or engage in solitary activities, or has received a documented ASD diagnosis). If abstraction “triggers” are found, evaluation information from birth through the current surveillance year is abstracted into a single composite record for each child.

In the second phase of ADDM surveillance, the abstracted composite evaluation files are de-identified and reviewed systematically by trained clinicians to determine ASD case status.

Clinicians use a surveillance case definition operationalized from the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for autism spectrum disorder. A child could meet the surveillance case definition for ASD under one or both of the following criteria, as documented in abstracted comprehensive evaluations: 1) behaviors consistent with the DSM-5 diagnostic features; and/or 2) any ASD diagnosis documented in a comprehensive evaluation. A child might be disqualified from meeting the surveillance case definition for ASD if, based on the clinical judgment of one or more clinician reviewers, there is insufficient or conflicting information in support of ASD, sufficient information to rule out ASD, or if one or more other diagnosed conditions better account for the child’s symptoms.

Co-occurring Intellectual Disability Criteria - Intellectual disability (ID) is defined as a condition marked by an intelligence quotient (IQ) of 70 or lower on the most recently administered psychometric test (Decouflé P, Boyle CA. The relationship between maternal education and mental retardation in 10-year-old children. Ann Epidemiol 1995;5(5):347-53). In the absence of an IQ score, a written statement by a psychometrist that a child’s intellectual functioning falls within the range for intellectual disability is acceptable, provided this statement is based on intellectual testing administered or attempted. The severity of intellectual disability is defined according to the following International Classification of Disease, Tenth Edition, Clinical Modification (ICD-10-CM) categories: mild (IQ of 50-70), moderate (IQ of 35-49), severe (IQ of 20-34), and profound (IQ below 20). NOTE: a concurrent impairment in adaptive functioning is not required to meet the surveillance criteria for co-occurring intellectual disability.

Data Management - All sites funded under this cooperative agreement will conduct data collection for core surveillance activities using a CDC-provided data collection and management system. CDC will provide technical support for installing the system and upgrades, and CDC will provide tools for data cleaning and closeout. At the conclusion of each surveillance cycle, data for scientific analysis will be exported from the system using a program furnished by CDC. The program strips all identifiers from the site's data and creates summary tables to be used for analysis.

These files are provided from all ADDM sites to CDC, and CDC appends data from all sites into a pooled analysis dataset for each surveillance cycle. These datasets are used for the combined ADDM Network prevalence report(s) for each surveillance cycle, and they are furnished to all participating sites for further analysis on special topics of interest. A subset of this dataset may be requested by outside investigators in the form of a public-use dataset containing no personally identifying information and constructed to minimize the possibility of identification of individuals. CDC and the ADDM sites will agree on which data elements to make publicly available, but it is a requirement of all federally-funded programs to comply with the CDC Data Management and Sharing Policy (http://www.cdc.gov/maso/Policy/ReleasingD ata.pdf) and furnish data for public use, so all funded sites are required to make these data available in an established manner.

Additional Activities for Strategy 1 (S1): [Component A] – 4-year-old and 8-year-old ASD Surveillance

Activity 2 (A2): Renew or establish agreements for data requests and access to data sources: Applicants must describe what types of data sources they anticipate will be available for surveillance in their proposed project area. Note that all possible sources within the surveillance area should be included, in addition to sources that are outside the surveillance area but may provide evaluations for a significant number of children who reside within the surveillance area. Sources should include a range of facilities that provide evaluation and treatment services for children with developmental disabilities, particularly ASD.

o Health Sources (including diagnostic and developmental assessment information) (required) o Education Sources (including evaluations to determine eligibility for special education services under Part B of IDEA, e.g., psychological evaluations to http://www.cdc.gov/maso/Policy/ReleasingData.pdf determine special education eligibility, physical therapy and occupational therapy evaluations, speech/language pathology assessments) (strongly preferred) o Early Intervention Sources (including evaluations to determine eligibility for Early Intervention services under Part C of IDEA, physical therapy and occupational therapy evaluations, speech/language pathology assessments) (strongly preferred)

Activity 3 (A3): Staff training and continued education o Initial training of staff on ADDM methodology and case definitions per the

ADDM training guidelines and ADDM protocols with technical assistance provided by CDC o Continued education for staff based on Quality Assurance/Quality Control (QA/QC) results and training needs of sites and the ADDM Network o Each site must appoint a Confidentiality Officer and conduct initial and annual (refresher) training with staff on the ADDM confidentiality guidelines and any additional local requirements

Activity 4 (A4): Report clean, de-identified data with linkages to CDC o Routine data cleaning edit checks per CDC ADDM data cleaning manual in

CDC-provided web-based database o Run data cleaning programs and conduct final edit checks prior to submitting data to CDC for the ADDM pooled dataset o Perform data linkages to birth certificates and community indicators (e.g., socio-economic status) based on residency geocoding o Report data according to the established timeline o CDC will use pooled de-identified data to create the ADDM pooled dataset

Note: Any pooled data with other ADDM projects will be grouped as individual, de-identified data. All surveillance reports and results will be disseminated in non-personally identifiable, aggregate form. Applications must include a copy of the applicant’s Data Management Plan.

Strategy 2 (S2): [Component B] – 16-year-old ASD Surveillance Applicants may choose to apply for additional funding for 16-year-old ASD surveillance (follow-up of children born in 2002 and 2004 who were abstracted for the 2010 and 2012 surveillance years, respectively). Because there is substantial overlap in the activities for Component A and Component B, applicants for Component B need only address the following additional activities for Component B when describing activities under this strategy in their application.

Activity 5 (A5): Conduct follow-up through age 16 years of children born in 2002 and 2004 who were abstracted as pending ASD cases for the 2010 and 2012 ADDM surveillance years, collecting data on behavioral characteristics, associated features, co-occurring conditions, IQ and adaptive test scores, and educational service delivery (including transition planning), and determining ASD case classification.

The purpose of this activity is to obtain information on the characteristics of children aged 16 years who were previously abstracted at an ADDM Network site during ASD surveillance among 8-year-old children in 2010 and 2012, including children classified as ASD cases and non-cases. This information will provide information on how the characteristics of children with ASD differ at age 8 years and age 16 years, including behavioral characteristics, cognitive and adaptive function, co-occurring conditions, and special education services. It will also allow collection of data on post-graduation transition planning mandated for children with an Individualized Education Plan (IEP) through Part B of the Individuals with Disabilities Education Act (IDEA) beginning no later than age 15 years. In addition, this information will allow comparison of ASD case classification through the ADDM Network at two different ages, and differences in case classification using ADDM Network surveillance case definitions based on the DSM-5 and DSM-IV-TR diagnostic criteria.

Similar to the methodology for Component A, ASD surveillance among 16-year-old children will occur in two phases, with some differences as described here. In Phase I, applicants identify all children whose records were abstracted at an ADDM Network site during ADDM Network surveillance for ASD in 8-year-old children in 2010 and 2012. Applicants identify data sources serving these children at age 16 years including health and education sources, and identify source records to review based on a child’s year of birth and either 1) eligibility classifications in special education or 2) International Classification of Diseases, Ninth Revision (ICD-9) or Tenth (ICD-10) Revision billing codes for select childhood disabilities or psychological conditions. Applicants look for initial matches between children identified at age 8 in 2010/2012 and children whose records were provided through the data requests from health and education sources, based on matching the child’s first and last names and date of birth. For successful initial matches, children’s records are screened to confirm year of birth and residency in the surveillance area at some time during the surveillance year and to confirm the match based on an additional variable such as address, mother’s name, or birth certificate number. For confirmed matches, evaluation information from birth through the current surveillance year is abstracted into a single composite record for each child. If feasible and practical, the information abstracted can be limited to that contained in evaluations that were not previously abstracted, provided that the information that was previously abstracted can be imported into the composite record to ensure completeness of information from birth through age 16 years.

Optionally, when no match is identified at age 16 years for a child that was abstracted at age 8 years, the information can be checked against the National Death Index. The second phase of surveillance will be conducted as described in the previous section describing activities for Component A, with the exception that ASD case classification will use ADDM Network surveillance case definitions based on both DSM-5 and DSM-IV-TR diagnostic criteria. Data linkages, submission of de-identified data to CDC, and the data management plan will also be the same as that described for Component A.

Strategy 3 (S3): [Component A] - Site-initiated analyses Activity 6 (A6): Submit at least two manuscripts based on analyses in two of three topic areas

1. Use a variety of state-level administrative data to estimate an administrative ASD prevalence among children aged 0-21 years, including comparisons by ADDM/non- ADDM areas, and by demographic factors such as sex, race/ethnicity, SES, and rural/urban residence.

2. Compare characteristics of children with ASD identified at different ages.

3. Conduct analyses of disparities by sociodemographic factors for outcomes of interest

(e.g. prevalence, age at identification).

Strategy 4 (S4): [Component A] - Community education and outreach

Activity 7 (A7): Each ADDM site must engage partners and stakeholders by conducting community education and outreach activities aimed at increasing practical use of ADDM Network data, including addressing gaps in ASD identification and service delivery, particularly in underserved populations. These education and outreach activities directly support surveillance activities by helping to ensure continuous access to community data sources and fostering community use of ADDM data needed for public health practice and to track progress toward community goals.

o Stakeholder Meetings (required):

A required activity for this focus area is stakeholder meetings. ADDM sites must host and/or participate in either one-on-one or group meetings with data sources (e.g., state/local health departments, pediatric healthcare facilities, and school systems), partner organizations (e.g., local disability service providers, autism advocacy organizations) or/other local stakeholders (e.g., policymakers). These meetings may involve a presentation of the ADDM methodology and ADDM data.

o Participation in ADDM education & outreach calls and ADDM communications workgroups (required):

A required activity for this focus area is participation in the ADDM education and outreach workgroup and in the ADDM communication workgroup. ADDM sites must participate in the ADDM education and outreach workgroup and attend education and outreach conference calls.

In addition, at least one staff member per ADDM site is required to actively participate in the ADDM communication workgroup during which the ADDM sites will collaborate on the development of community reports, site success stories, and other materials for community stakeholders.

Education and outreach activities should also attempt to address disparities in identification of children with ASD and co-occurring DDs as indicated by ADDM data. For that reason, at least one education and outreach activity MUST be implemented in a way that targets under-identified populations (e.g., racial/ethnic minorities).

In addition to the required activities above, applicants must include in their application at least two additional activities. Additional activities that support education and outreach-related outcomes may be chosen from the following or proposed by the applicant.

Additional activities may include:

Community awareness events o ADDM sites may choose to organize community events to raise awareness about developmental disabilities. These events can be successful in numerous formats and should be tailored to the community audience and needs of the program.

These events can also be a platform for increasing visibility and recognition of an ADDM site. Successful events are implemented through collaborations between ADDM sites and community partners. Sites can also participate in existing events (e.g., host information booths at health fairs, give lectures or presentations on ADDM data, or provide information about developmental screening). Applicants should describe the proposed event and potential community partners in their application.

Trainings/presentations for community stakeholders (e.g., local clinicians or educators) o ADDM sites may choose to serve as a local educational and training resource, particularly in the area of ASD and co-occurring DD population-based surveillance. Trainings might include, but are not limited to, workshops for local service providers (e.g., special educators, pediatricians, or early intervention specialists), mentoring and internships.

Strategic outreach to identify program champions or supporters o ADDM sites may choose to reach out to leaders within state/local governments, universities, or relevant non-profit organizations in their project area to encourage interest and support for the surveillance program. Support from leaders in key positions is critical to program activities such as establishing data access agreements.

Participation/coordination/leadership in local health community groups (e.g., state autism consortium, medical advisor to local partner organization, board of local children’s hospital) o ADDM sites may choose to be involved in local community groups. Involvement is beneficial to the surveillance program and the community. Engagement with such groups raises situational awareness and offers information about the context of the surveillance program. Participation can range from presentations of data at local meetings to serving a leadership or facilitative role.

Development and dissemination of additional site-specific materials o Applicants may choose to develop and disseminate materials beyond those created by the ADDM communications workgroup (e.g., community reports, site success stories). Examples of site-specific materials might include a project website; an electronic and/or printed newsletter for data sources and community partners; or a webinar series for data sources, community partners, or other community stakeholders. Applicants must specify in their application which additional materials will be developed and disseminated and the target audience(s) for each.

Engagement in local news and social media o Applicants may choose to proactively engage with local news and social media.

Examples of engagement include, but are not limited to, conducting project-related interviews for local print, radio, and television and disseminating ADDM materials or messages via project specific or host (e.g., university, health department) social media accounts.

Collection of structured feedback from community stakeholders on community data needs or uses and/or on ADDM materials and dissemination channels.

o Applicants may choose to collect structured feedback from community stakeholders. The feedback should focus on community data needs and uses as it relates to ASD and co-occurring DD surveillance and evaluating ADDM materials and dissemination channels. Such feedback could be used internally to better understand the data needs and uses of the community and to improve future ADDM materials and dissemination channels. Applicants should specify in their application how and from whom structured feedback will be collected.

Strategy 5 (S5): [Components A and B] - Monitoring and Evaluation Activities for Components A and B include:

Applicants must describe their plans to (A8) create and implement a site strategic plan based on the CDC ADDM Logic Model and the strategies/activities described above.

The strategic plan must be submitted to CDC within six months of the award. Recipients must plan to have monthly meetings to track efforts toward achieving strategic plans, and send semi-annual reports of strategic plan progress to CDC.

Additionally, applicants must describe the activities they propose to use for monitoring and performance measurement, including plans to (A9) complete a site-specific, non-research evaluation plan. Details of the CDC Evaluation and Performance Measurement plan (and expectations for applicants/recipients) are provided in the Evaluation and Performance Measures section below.

In order to achieve and maintain reliability of the ADDM Network and methodology, applicants must agree to (A10) conduct ongoing quality assurance and control activities (QA/QC) per the ADDM QA/QC protocols for abstractors, clinician reviewers and project coordinators.

1. Collaborations

a. With other CDC programs and CDC-funded organizations:

(REQUIRED)

Applicants must describe how they plan to work with other CDC-funded ADDM sites in order to achieve the outcomes of the NOFO. Examples of anticipated collaborations:

Collaboration with other ADDM sites and CDC to implement datasharing policies and pooling of data across sites. Pooled datasets will be shared among participating ADDM investigators and ultimately released as both open and restricted access public use datasets. For CDC’s policies on releasing and sharing data see http://www.cdc.gov/maso /Policy/ReleasingData.pdf.

Collaboration with other ADDM sites to coordinate methods for data collection, case determination, evaluation, analysis and dissemination for multiple source surveillance.

Participation on ADDM committees (e.g., Project Coordinators/Abstractors, Principal Investigators, Clinician Reviewers, Abstraction Quality Assurance, Education and Outreach, and Scientific Issues), collaborative meetings, and surveillance publications and reports, as appropriate.

b. With organizations not funded by CDC:

(REQUIRED)

Sites must develop and maintain collaborative relationships with appropriate professionals and organizations that may be sources for data or stakeholders.

Agreements to access evaluation records of potential case children should be made at the institutional level in the form of a contract, memorandum of understanding (MOU) or other formal agreement allowing access to source records. Each applicant must address relevant issues for their access to records. In some cases passive or active authorization may be required of parents to access their child’s records. It is the site’s responsibility to ensure any appropriate assurances/approvals are received prior to accessing children’s records, even if parental active or passive authorization is required. Data requests should include a range of diagnoses and special education exceptionalities in order to access records of children that may have ASD, including those with co-occurring ID.

Additionally, data requests should include service years from birth (for 8-year-olds, 2010 and 2012; for 4-year-olds, 2014 and 2016) through 2018 (for SY2018) and 2020 (for SY2020) in order to access records from throughout a child’s life that may include relevant information to establishing case status. Previous ADDM reports have indicated that access to education sources is essential to ensure as complete a count of children with ASD as possible. Therefore, it is strongly preferred that sites have access to education records for the entire surveillance area. Access to early intervention records is also strongly preferred. Formal agreements related to access to records must be included with the application. Applicants must provide a letter of support, Memorandum of Understanding (MOU), or other documentation to indicate the applicant has access to source records. The file should be named "MOU" or "letter of support" and place this documentation in Appendix A and attach with "Other Attachment Forms" when submitting via www.grants.gov.

2. Target Populations Component A (required): surveillance of autism spectrum disorder among children aged 4 and 8 years in 2018 and 2020

Sites will identify a core surveillance area composed of populations of 12,000 (minimum) - 25,000 (strongly recommended maximum) for both 4-year-old and 8-year-old children during the most recent calendar year included in bridged-race postcensal population estimates published by CDC/NCHS/NVSS.

The core surveillance area must be comprised of a contiguous geographic sector lying entirely within one US state or territory, defined by clear state, county, or school district boundaries. Additional geographic areas may be included, provided that the contiguous portion satisfies the minimum population requirement for the core surveillance area.

The first surveillance year will include children born in 2010 or 2014 who resided in the surveillance area during 2018. The second surveillance year will include children born http://www.grants.gov in 2012 or 2016 who resided in the surveillance area during 2020.

Component B (optional): Optional 16-year-old ASD follow-up surveillance for 2018 and 2020.

For the first surveillance year, sites will identify children born in 2002 who were abstracted for ASD at an ADDM Network site that participated in the 2010 surveillance year. The second surveillance year will include children born in 2004 who were abstracted for ASD at an ADDM Network site that participated in the 2012 surveillance year.

a. Health Disparities This NOFO will provide data on the prevalence, age at identification, and other characteristics of ASD among sub-populations (e.g., by sex, race/ethnicity, and urban vs. rural areas).

Understanding of these differences helps to target education and outreach activities as well as inform policies that address services for individuals with ASD.

iv. Funding Strategy This cooperative agreement provides multiple options that applicants can select for development and action. Component A funds surveillance of autism spectrum disorder (ASD) among 4-year-olds and 8-year-olds. Component B funds follow-up at age 16 years of children abstracted for ASD at age 8 years in 2010 and 2012. Component A is required for all applicants, while Components B is optional. The annual awards range from $525,000-$625,000 for Component A and $100,000-$150,000 for Component B.

b. Evaluation and Performance Measurement

i. CDC Evaluation and Performance Measurement Strategy This section outlines evaluation and performance measures for successful implementation and outcome assessment of ADDM activities.

Evaluation and performance measurements will focus on 1) surveillance process, including training, data acquisition, cleaning, linking, and reporting, and 2) program outcomes, including efficiency improvements, community education and outreach, analyses, and dissemination of results. Outcome measures will correspond to outcomes as presented in the logic model.

CDC and recipients will use findings from these measures to: 1) ensure program implementation and continuous system improvement, 2) demonstrate achievement of program outputs and short-term outcomes, 3) provide an evidence base for potential future changes to the ADDM Network surveillance methodology, and 4) assess the usefulness, scalability, and effectiveness of community education and outreach strategies. Information will lead to improvements in implementation of current and future ADDM activities, and demonstrate progress toward reaching ADDM program goals. Findings may be disseminated to sites, the whole ADDM Network, or in publications to improve upon or report on the ADDM Network’s performance in achieving strategic and scientific objectives.

Evaluation and performance measures must be tracked by sites and reported to CDC as requested. Key questions and performance measures apply to Component A (4 year and 8-year-old surveillance). Sites should track measures separately for 4 year-old and 8-year-old surveillance. Sites applying for Component B should present a plan for performance measurement of these additional components.

Key Questions and Performance Measures— a.PROCESS questions and measures Sites should report the following questions and measures to CDC:

Activity 1: Adhere to standardized ADDM Network methodology and case definitions

Did site install data collection/management system within 1 month of notice of funding opportunity?

Number of health records in tracking Number of education records in tracking Number of health records abstracted Number of education records abstracted Number (%) of records with abstraction batch edits Number of records assigned to clinician reviews within 2 weeks of availability of compiled record Number (%) of records with clinician review batch edits Number of clinician reviews completed

Activity 2: Renew or establish agreements for data requests and access to data sources

Number of health data sources identified and with data use agreements in place within three months of notice of funding opportunity

Number of education data sources identified and with data use agreements in place within three months of notice of funding opportunity

Number of data requests received Number of health sources imported into data collection/management system for current surveillance year Number of education sources imported into data collection/management system for current surveillance year

Activity 3: Staff training and continued education

Did project coordinator complete CDC orientation?

Number of trained data abstractors

Activity 4: Report clean, de-identified data with vital records/census linkages to CDC

Resolve all data edits before transmission to CDC Link surveillance case data to census data prior to transmission to CDC Link surveillance case data to birth certificate data prior to transmission to CDC

Activity 5: Conduct follow-up at age 16 years of children born in 2002/2004 who were abstracted as pending ASD cases for the 2010/2012 ADDM

Number of health data sources identified and with data use agreements in place Number of education data sources identified and with data use agreements in place Number of children whose records were abstracted at an ADDM Network site during

ASD surveillance among 8-year-old children in surveillance year 2010/2012

Activity 6: Submit at least two manuscripts based on analysis in two of three topic areas

Number of site-led analyses proposed Number of site-led abstracts presented at conferences Number of site-led publications submitted for CDC review or publication

Activity 7: Community Education and Outreach

Number of presentations and outreach events Approximate number of people reached through presentations and outreach events Number of new partnerships or collaborations established Number of “hits” to site websites containing ADDM data

Activity 8: Create and implement a strategic plan

Strategic plan submitted to CDC within six months of notification of award

Activity 9: Complete a site evaluation plan

Site evaluation plan developed and submitted to CDC within six months of notification of award

Activity 10: Conduct ongoing quality assurance and control activities (QA/QC)

Number of clinician reviewers that submit reliability scoring to CDC Percent agreement on decision to abstract based on 10% sample Number of clinician reviewers meeting initial reliability Percent agreement for site ongoing clinician review reliability b.OUTCOME questions and measures Sites should report the questions and measures listed below to CDC. These questions and measures correspond to outcomes in the logic model.

Outcome 1: Improved understanding of ASD, including trends and disparities in ASD prevalence over time and by demographic factors

Did site transmit final dataset to CDC by established deadline?

Did site use a multiple-source methodology to conduct ASD surveillance?

Proportion of surveillance area population living in school districts where sites have permission to access education records

Outcome 2: Strengthened ASD surveillance among 4-year-old children

Proportion of surveillance area population of 4-year-old children for which early identification records were available

Outcome 3: Improved understanding of differences in ASD characteristics by age

Number of analyses and submitted manuscripts addressing differences in ASD characteristics by age

Outcome 4: Stronger relationships between recipient and partners/data sources

Number of new programs or projects resulting from ADDM network collaboration or data

Outcome 5: Increased dissemination of ADDM Network data

Approximate number of inquiries/requests for ADDM data Number of submitted publications using ADDM Network data Number of presentations on ADDM Network data

Outcome 6: Improved reliability and efficiency of ADDM surveillance

Does site have a written plan to address concordance rates that are at or near 80%? If yes, describe plan.

Does site have a written plan to address clinician reliability that falls <90%? If yes, describe plan

Did site propose methods to improve efficiency of data abstraction or clinician review?

If yes, describe.

Outcome 11: Improved policies and plans that address ASD research agendas and services for children with ASD

Is site aware of any new or updated state policies that address services for…