Supporting Statement A
for
Fetal Alcohol Spectrum Disorders Regional Training Centers (RTCs)
New Request
Primary Contact:
Elizabeth P. Dang, MPH
CDC/NCBDDD
1600 Clifton Road, NE
Mailstop E-86
Atlanta, GA 30333
edang@cdc.gov
404-498-3947
Fax 404-498-3550
Table of Contents
A. Justification
A.1. Circumstances Making the Collection of Information Necessary
A.2. Purpose and Use of the Information Collection
A.3. Use of Improved Information Technology and Burden Reduction
A.4. Efforts to Identify Duplication and Use of Similar Information
A.5. Impact on Small Businesses or Other Small Entities
A.6. Consequences of Collecting the Information Less Frequently
A.7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
A.8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
A. 9. Explanation of Any Payment or Gift to Respondents
A.10. Assurance of Confidentiality Provided to Respondents
A.11. Justification for Sensitive Questions
A.12. Estimates of Annualized Burden Hours and Costs
A.13. Estimates of Other Total Annual Cost Burden to Respondents and Record Keepers
A.14. Annualized Cost to the Federal Government
A.15. Explanation for Program Changes or Adjustments
A.16. Plans for Tabulation and Publication and Project Time Schedule
A.17. Reason(s) Display of OMB Expiration Date is Inappropriate
A.18. Exceptions to Certification for Paperwork Reduction Act Submissions
LIST OF ATTACHMENTS
Attachment A: Applicable Laws or Regulations
A1. Section 301 of the Public Health Service Act (42 U.S.C. 241)
Attachment B: 60-day Federal Register Notice
Attachment C1 – C16: Arctic RTC Information Collection Instruments
C1. Arctic RTC Foundations Pre
C2. Arctic RTC Foundations Post
C3. Arctic RTC Foundations Follow-up
C4. Arctic RTC FASD 201 Pre
C5. Arctic RTC FASD 201 Post
C6. Arctic RTC FASD 201 Follow-up
C7. Arctic RTC Intro to FASDs Pre
C8. Arctic RTC Intro to FASDs Post
C9. Arctic RTC Intro to FASDs Follow-up
C10. Arctic RTC Train-the-Trainer Pre
C11. Arctic RTC Train-the-Trainer Post
C12. Arctic RTC Train-the-Trainer Follow-up
C13. Arctic RTC Online Course I Pre, Post
C14. Arctic RTC Online Course II Pre, Post
C15. Arctic RTC Online Course III Pre, Post
C16. Arctic RTC Classroom/Special Event Post Presentation
Attachment D1 – D18: Frontier RTC Information Collection Instruments
D1. Frontier RTC Nursing Pre-test
D2. Frontier RTC Nursing Post-test
D3, Frontier RTC Nursing Follow-up
D4. Frontier RTC Social Work Pre-test
D5. Frontier RTC Social Work Post-test
D6. Frontier RTC Social Work Follow-up
D7. Frontier RTC Practitioner Pre-test
D8. Frontier RTC Practitioner Post-test
D9. Frontier RTC Practitioner Follow-up
D10. Frontier RTC Training of Trainers Pre-test
D11. Frontier RTC Training of Trainers Post-test
D12. Frontier RTC Training of Trainers Follow-up
D13. Frontier RTC Online Academic Pre-test
D14. Frontier RTC Online Academic Post-test
D15. Frontier RTC Online Academic Follow-up
D16. Frontier RTC Online Practitioner Pre-test
D17. Frontier RTC Online Practitioner Post-test
D18. Frontier RTC Online Practitioner Follow-up
Attachment E1 - E-19: Great Lakes RTC Information Collection Instruments
E1. Great Lakes FASD RTC Foundations of FASD Pre-Training Evaluation
E2. Great Lakes FASD RTC Foundations of FASD Post-Training Evaluation
E3. Great Lakes FASD RTC Foundations of FASD 6-month Follow-up
E4. Great Lakes FASD RTC Screening and Brief Intervention Pre-Training Evaluation
E5. Great Lakes FASD RTC Screening and Brief Intervention Post-Training Evaluation
E6. Great Lakes FASD RTC Screening and Brief Intervention 6-month Follow-up Evaluation
E7. Great Lakes FASD RTC Identification and Treatment of FASD Pre-Training Evaluation
E8. Great Lakes FASD RTC Identification and Treatment of FASD Post-Training Evaluation
E9. Great Lakes FASD RTC Identification and Treatment of FASD 6-month Follow-up Evaluation
E10. Great Lakes FASD RTC FASD Comprehensive Pre-Training Evaluation
E11. Great Lakes FASD RTC FASD Comprehensive Post-Training Evaluation
E12. Great Lakes FASD RTC FASD Comprehensive 6-month Follow-up Evaluation
E13. Great Lakes FASD RTC Clinical Experience A Evaluation Form
E14. Great Lakes FASD RTC Clinical Experience B Evaluation Form
E15. Great Lakes FASD RTC Key Informant Interview Training of Trainers Participants
E16. Great Lakes FASD RTC Key Informant Interview State Partners
E17. Great Lakes FASD RTC Key Informant Interview Advisory Committee
E18. Great Lakes FASD RTC Harvard Minute Feedback Form
E19. Great Lakes FASD RTC Training Activity Reporting Form (TARF) with Process Notes
Attachment F1 – F8: Midwest RTC Information Collection Instruments
F1. Midwest FASD RTC Knowledge Assessment Pre-Test
F2. Midwest FASD RTC Knowledge Assessment Post-Test, 3-month follow-up
F3. Midwest FASD RTC Event Evaluation
F4. Midwest FASD RTC Continuing Education Event, Practice Behaviors/Self-Efficacy Pre-Test
F5. Midwest FASD RTC Continuing Education Event, Practice Behaviors/Self-Efficacy Post-Test
F6. Midwest FASD RTC Continuing Education Event, Practice Behaviors/Self-Efficacy 3-month Follow-up
F7. Midwest FASD RTC Modified Index of Interdisciplinary Collaboration Pre-Test, 3-month follow-up
F8. Midwest FASD RTC Utilization of FAS/FASD Curriculum Pre-evaluation, 3-month follow-up
Attachment G1 – G3: Southeast RTC Information Collection Instruments
G1. FASD Southeast RTC Pre-Test Evaluation Questions
G2. FASD Southeast RTC Post-Test Evaluation Questions and Program Evaluation
G3. FASD Southeast RTC 3-month Follow-up
Attachment H: IRB Findings
Supplemental Forms (Screenshots)
Great Lakes RTC:
(E1a). Foundations of FASD Pre/QUALTRICS online
(E2a). Foundations of FASD, Post
(E3a). Foundations of FASD 6-month follow-up
(E4a). Screening and Brief Intervention, Pre
(E5a). Screening and Brief Intervention, Post
(E6a). Screening and Brief Intervention, 6-month follow-up
(E7a). Identification and Treatment of FASD, Pre
(E8a). Identification and Treatment of FASD, Post
(E9a). Identification and Treatment of FASD, 6-month follow-up
(E10a). Comprehensive, Pre
(E11a). Comprehensive, Post
(E12a). Comprehensive, 6-month follow-up
Midwest RTC:
(F2a). Knowledge Assessment Post, 3-month follow-up
(F7a). Modified Index of Interdisciplinary Collaboration Pre, 3-month follow-up
(F8a). Utilization of FAS/FASD Curriculum Pre, 3-month follow-up
A. Justification
A. 1. Circumstances Making the Collection of Information Necessary
Background:
This data collection activity is a new request and is authorized by Section 301 of the Public Health Service Act [42 U.S.C. 241] (attachment A1). The request is for OMB approval for 2 years of information collection. The proposed information collection is also consistent with the aims of the Children’s Health Act of 2000 which established the Centers for Disease Control and Prevention’s (CDC’s) National Center on Birth Defects and Developmental Disabilities (NCBDDD) to (1) collect, analyze, and make available data on birth defects and developmental disabilities; (2) conduct applied epidemiological research on prevention of such defects and disabilities; and (3) provide birth defect and developmental disability prevention information and education to the public. Additionally, the Children’s Health Act of 2000 mandated that all programs and functions of the National Center for Environmental Health be transferred to NCBDDD, including all programs and functions that related to birth defects, folic acid, cerebral palsy, mental retardation, child development, newborn screening, autism, fragile X syndrome, fetal alcohol syndrome, pediatric genetics, and disability prevention.
Maternal prenatal alcohol use is one of the leading, preventable, causes of birth defects and developmental disabilities. Children exposed to alcohol during fetal development can suffer a wide array of disorders, from subtle changes in I.Q. and behaviors to profound intellectual disability. These conditions are known as fetal alcohol spectrum disorders (FASDs). The most severe condition within the spectrum is fetal alcohol syndrome (FAS), which involves disorders of the brain, growth retardation, and facial malformations (Stratton et al., 1996; U.S. Department of Health and Human Services, 2000).
Health care professionals play a crucial role in identifying women at risk for an alcohol-exposed pregnancy and in identifying effects of prenatal alcohol exposure in individuals. However, despite the data regarding alcohol consumption among women of childbearing age and the prevalence of FAS, screening for alcohol use among female patients of childbearing age and diagnosis for FAS and related conditions are not yet common standards of care. In 2002, Congress mandated that CDC’s NCBDDD, in coordination with the National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol Effect (NTFFAS/FAE), other federally funded FAS programs, and appropriate nongovernmental organizations, develop guidelines for the diagnosis of FAS and other prenatal alcohol-related conditions and incorporate these guidelines into curricula for medical and allied health students and practitioners. This was also reflected in recommendations put forth by the NTFFAS which were published in September 2002, recommending to “Investigate incorporating information related to prevention and treatment of FAS and Alcohol-Related Neurodevelopmental Disorder (ARND) into the credentialing requirements for teachers, juvenile justice workers, lawmakers, and health-care professionals (e.g., include FAS-related questions on state board exams)” (Centers for Disease Control and Prevention, 2002). In addition, it is known from surveys of multiple provider types that although they might be familiar with the etiology, teratology, and clinical presentation of FAS and FASDs, they report feeling less prepared to identify and counsel women at risk for an alcohol-exposed pregnancy (e.g., obstetrician-gynecologists) or diagnose or identify for referral a child with FAS, and even less prepared to manage and coordinate the treatment of children with FASDs (e.g., pediatricians) (Anderson et al., 2010; Diekman et al., 2000; Gahagan et al., 2006). One of CDC’s multifaceted initiatives in combating alcohol-exposed pregnancies is the education and re-education of medical and allied health students and practitioners.
FASD Regional Training Centers. There is a need for the training of medical and allied health students and practitioners in the prevention, identification, and management of FASDs, hence the recommendations that have been put forward in this area. As part of the fiscal year 2002 appropriations funding legislation, the U.S. Congress mandated that the CDC, acting through the NCBDDD FAS Prevention Team and in coordination with the NTFFAS/FAE, other federally funded FAS programs, and appropriate nongovernmental organizations (NGOs), would (1) develop guidelines for the diagnosis of FAS and other negative birth outcomes resulting from prenatal exposure to alcohol; (2) incorporate these guidelines into curricula for medical and allied health students and practitioners and seek to have them fully recognized by professional organizations and accrediting boards; and (3) disseminate curricula to and provide training for medical and allied health students and practitioners regarding these guidelines. As part of CDC’s response to this mandate, a total of seven FASD Regional Training Centers (RTCs) have been established since 2002 to train medical and allied health students and professionals regarding the prevention, identification, and treatment of FAS and related disorders, now known collectively as FASDs. The establishment of the RTCs is outlined in Section 317K of the Public Health and Welfare Act (42 U.S.C. 247b-12) b and c]. The FASD RTCs have developed and implemented ongoing FASD training programs and courses throughout their regions reaching medical and allied health professionals and students. Trainings are delivered in academic settings (medical and allied health schools) and via continuing education events for practicing medical and allied health professionals. Training delivery varies by RTC depending on the target audience and setting. Examples include a five-week online course for practicing social work, nursing, and substance abuse professionals (Attachments D13-D18), a two-hour face-to-face training for nursing and social work students (Attachments D1-D6), a train-the-trainer model with 1- to 5-day trainings for trainers who then deliver at least two trainings per year to students and professionals (Attachments C10-C12; D10-D12). One RTC also offers a unique training experience for medical students to observe a pediatric geneticist during an FASD assessment. This training is evaluated using a specific pre- and post-training assessment tool (Attachments E13 and E14). The currently funded FASD Regional Training Centers are the following: Arctic (based at University of Alaska Anchorage), Frontier (based at University of Nevada Reno), Great Lakes (based at the University of Wisconsin), Midwestern (based at Saint Louis University), and Southeastern (based at Meharry Medical College).
These efforts are directed at accomplishing the following U.S. Department of Health and Human Services Healthy People 2020 maternal, infant and child health (MICH) objectives: MICH-11 (Increase abstinence from alcohol, cigarettes, and illicit drugs among pregnant women), MICH-16 (Increase the proportion of women delivering a live birth who received preconception care services and practiced key recommended preconception health behaviors (including abstaining from alcohol in the three months prior to pregnancy), and MICH-25 (Reduce the occurrence of fetal alcohol syndrome) (U.S. Department of Health and Human Services, 2011).
1.1 Privacy Impact Assessment
Overview of the Data Collection System
The FASD RTCs will be collecting evaluation information on the trainings they offer for medical and allied health students and practitioners.
The following evaluation methods will be employed: Evaluation surveys in pencil-and-paper format, as well as online web-based evaluation surveys in some cases, will be given to participants of RTC trainings at pre-training, immediate post-training, and post-training follow-up. The evaluation assessments will be administered by the training organizers.
The FASD Regional Training Centers will be collecting evaluation information on a multitude of trainings for medical and allied health students, residents, and practitioners. Each RTC has developed its own series of evaluation instruments tailored to the types of trainings it provides (Attachments C1 – C16: Arctic RTC; Attachments D1 - D18: Frontier RTC; Attachments E1 – E19: Great Lakes RTC; Attachments F1 – F8: Midwestern RTC; and Attachments G1 – G3: Southeastern RTC). The intent of the collection information is two-fold: (1) each FASD Regional Training Center will be using a variety of evaluation instruments, depending on the target audience and the training setting with the intent to evaluate their own training center’s activities, and (2) because each evaluation instrument also contains a core set of items that are the same across all FASD Regional Training Centers for assessing knowledge, practice behaviors, and comfort and self-efficacy to perform certain skills related to the prevention, identification, and treatment of FASDs, it will be possible to evaluate certain aspects of the collective FASD Regional Training Centers’ activities using consistent measures.
Electronic data will be stored on each FASD Regional Training Center’s university server, which is password-protected. Although the hard-copy pre/post-test assessments will contain no personal identifying information, they will be stored in a locked file room at the FASD Regional Training Centers’ respective offices separate from all other project data. The data and subsequent analyses will be stored electronically for five years at which time they will be destroyed. Access to raw data will be limited to FASD Regional Training Center collaborators (as identified in section A.8.B.). CDC will receive only summarized, aggregate data in the form of evaluation reports, interim progress reports, and final project reports.
Items of Information to be Collected
For the purpose of the evaluation, no individually identifiable information is being collected. Data collection, including for the 3- or 6-month follow up (Attachments C3, C6, C9; Attachments D3, D6, D9, D12, D15, D18; Attachments E3, E6, E9, E12; Attachments F2, F6, F7, F8; Attachment G3), will be anonymous; the evaluation forms themselves will have no identifying information or any link to names or contact information.
Identification of Website(s) and Website Content Directed at Children Under 13 Years of Age
No website content directed at children under 13 years of age is involved in this information collection request.
A. 2. Purpose and Use of Information Collection
The goal for the FASD Regional Training Centers is to provide quality services and products for this systematic educational outreach effort. In order to assess whether the trainings reach the intended goals, information must be collected to assess whether participants are satisfied with these trainings and whether their knowledge and behavior have changed. Information will be collected at multiple points in time – pre-training (Attachments C1, C4, C7, C10, C13 – C15; D1, D4, D7, D10, D13, D16; E1, E4, E7, E10, E13; F1, F4, F7, F8; and G1) immediate post-training (Attachments C2, C5, C8, C11, C13 – C16; D2, D5, D8, D11, D14, D17; E2, E5, E8, E11, E14; F2, F5; and G2) and follow-up at 3 or 6 months post-training (Attachments C3, C6, C9; Attachments D3, D6, D9, D12, D15, D18; Attachments E3, E6, E9, E12; Attachments F2, F6 – F8; Attachment G3). The Great Lakes RTC will also conduct qualitative key informant interviews with training of trainers participants, state partners, and advisory committee members at the end of each project year (E15-E17). Each RTC has designed evaluation instruments that are tailored for their specific types of training events they offer and tailored to the audience for various types of trainings (e.g., medical students/residents, health care professionals, train-the-trainer participants). The results from the evaluations will be used to identify strengths and weaknesses of the trainings provided by the RTCs in order to identify areas of improvement and expansion. The information gathered by the surveys will assist each RTC in program planning, including revisions to the curriculum and training delivery. In addition, because each evaluation instrument also contains a core set of items that are the same across all FASD Regional Training Centers for assessing knowledge, practice behaviors, and comfort and self-efficacy to perform certain skills related to the prevention, identification, and treatment of FASDs, it will be possible to evaluate certain aspects of the collective FASD Regional Training Centers’ activities using consistent measures. This will provide CDC’s FAS Prevention Team with information regarding the effectiveness of the FASD Regional Training Centers’ training efforts as a whole and will assist with future program planning. Without this information collection, it will not be possible to ascertain whether the FASD Regional Training Centers are effective in improving the knowledge, skills, and practice behaviors of medical and allied health students/residents and practitioners in addressing the prevention, identification, and management of FASDs.
2.1 Privacy Impact Assessment
For the purpose of the evaluations, no individually identifiable information is being collected. Data collection, including for the 3- or 6-month follow up (Attachments C3, C6, C9; Attachments D3, D6, D9, D12, D15, D18; Attachments E3, E6, E9, E12; Attachments F2, F6 – F8; Attachment G3), will be anonymous; the evaluation forms themselves will have no identifying information or any link to names or contact information. Contact information will be stored in a secure manner and separate from the data. Therefore the data collection is not anticipated to have any impact on the respondent’s privacy. Descriptive summaries of the responses will be used for quality control reports and submitted to CDC. None of the contact information will be submitted to CDC.
A. 3. Use of Improved Information Technology and Burden Reduction
For practical purposes, most of the evaluation forms for the trainings will be administered via pencil-and-paper questionnaire. As indicated in the table of estimated annualized burden hours, certain instruments (such as the 3- or 6-month follow-up assessments) are online evaluations. This means that 27% of data collection (4,255 of 15,640 surveys) will be taking place via advanced information technology. See Burden Table in section A12. This will reduce the burden to the participants by allowing instant submission of responses and by not requiring responses to be returned via mail. It is not feasible to conduct the evaluations at the beginning and end of the in-person trainings electronically, since computer access cannot be made available and response rates for surveys to be completed later from a different location rather than immediately at the end of the workshop would be significantly lower.
A. 4. Efforts to Identify Duplication and Use of Similar Information
There are no similar data. The trainings held by the FASD Regional Training Centers are unique and not held by other organizations, and are continuously updated, so ongoing data collection to evaluate these trainings is needed.
A. 5. Impact on Small Businesses or Other Small Entities
No small businesses will be involved in this data collection.
A. 6. Consequences of Collecting the Information Less Frequently
The information will be collected at three points in time for training participants. This will occur immediately prior to the training (Attachments C1, C4, C7, C10, C13 – C15; D1, D4, D7, D10, D13, D16; E1, E4, E7, E10, E13; F1, F4, F7, F8; and G1), immediately following the training (Attachments C2, C5, C8, C11, C13 – C16; D2, D5, D8, D11, D14, D17; E2, E5, E8, E11, E14; F2, F5; and G2), and at a 3- or 6-month follow-up period depending on the FASD Regional Training Center (all FASD Regional Training Centers conduct their follow-up at 3 months following the training with the exception of the Great Lakes Regional Training Center, which conducts follow-up at 6 months [Attachments C3, C6, C9; Attachments D3, D6, D9, D12, D15, D18; Attachments E3, E6, E9, E12; Attachments F2, F6 – F8; Attachment G3]). The Great Lakes RTC will also conduct qualitative key informant interviews with training of trainers participants, state partners, and advisory committee members at the end of each project year (E15-E17). It is important to assess the effectiveness of the trainings for all participants, and it is necessary to conduct a follow up survey to assess whether the trainings were effective to allow retention in knowledge gained through the workshops as well as to assess change in actual behavior in medical professionals who attended the trainings. Collecting information less frequently would not allow accurate evaluation of the trainings.
A. 7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances with this information collection package. This request fully complies with the guidelines of 5 CFR 1320.5.
A. 8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency
A. A copy of the agency’s 60-day Federal Register Notice is attached (60-day Federal Register Notice Attachment B). The notice, as required by 5 CFR 1320.8 (d), was published on May 8, 2012 (volume 77, number 89, pages 27067 - 27070). Two non-substantive comments were received in response to this notice.
B. This data collection effort has been developed in collaboration with the FASD Regional Training Centers and thus represents consultation outside of the agency.
The following members of the FASD Regional Training Centers have participated in the development and review of the information collection procedures:
FASD Regional Training Centers collaborators
Christiane Brems,
PhD, ABPP, Co-Director, Behavioral Health Research & Services,
UAA Director of Clinical Training and Professor of Psychology, Center
for Behavioral Health Research & Services, University of Alaska
Anchorage, 3401 E. 42nd Street, Suite
200/201, Anchorage, AK 99508, afcb@uaa.alaska.edu
Kristy
Durkin, MSW, LCSW, Social Worker, Department of Family and Community
Medicine, Meharry Medical College, 1005 D.B. Todd Jr. Blvd,
Nashville, TN 37208-3599, kgoodman@mmc.edu
Bridget
Hanson, PhD, Research Assistant Professor, Center for Behavioral
Health Research & Services, University of Alaska Anchorage, 3401
E. 42nd Street, Suite 200/201, Anchorage, AK
99508, afblh1@uaa.alaska.edu
Joyce A. Hartje, PhD,
Evaluation Research Manager, Center for the Application of Substance
Abuse Technologies, University of Nevada, Reno, 800 Haskell St.,
First Floor, Reno, NV 89509, jhartje@casat.org
Mark Johnson,
PhD, Co-Director, Behavioral Health Research & Services,
Professor of Psychology, Center for Behavioral Health Research &
Services, University of Alaska Anchorage, 3401 E. 42nd
Street, Suite 200/201, Anchorage, AK 99508, afmej@uaa.alaska.edu
Robert Levine, MD, Professor of Family and Community
Medicine, Director of the Research Division, Meharry Medical College,
1005 D.B. Todd Jr. Blvd., Nashville, TN 37208-3599, rlevine@mmc.edu
Ginger Mongeau, BBA, Data Manager, Center for Behavioral Health Research & Services, University of Alaska Anchorage, 3401 E. 42nd Street, Suite 200/201, Anchorage, AK 99508, anval@uaa.alaska.edu
Becky Porter, MS, LPC, Center for Behavioral Health Research & Services, University of Alaska Anchorage
3401 E. 42nd Street, Suite 200/201, Anchorage, AK 99508, rrporter2@uaa.alaska.edu
Nancy
Roget, MS, Principle Investigator/Executive Director, Center for the
Application of Substance Abuse Technologies (CASAT), University of
Nevada, Reno, 800 Haskell St., First Floor, Reno, NV 89509,
nroget@casat.org
Barbara Vardalas, MA, Associate Researcher, University of Wisconsin, Department of Family Medicine, 1100 Delaplaine Court, Madison, WI 53715, barbara.vardalas@fammed.wisc.edu
Georgiana
Wilton, PhD, Associate Scientist, University of Wisconsin School of
Medicine and Public Health,
Department of Family Medicine, 1100 Delaplaine Court, Madison, WI 53715, georgiana.wilton@fammed.wisc.edu
Roger Zoorob, MD, MPH, FAAFP, Frank S. Royal Sr. Professor
and Chair, Department of Family and Community Medicine, Meharry
Medical College, Director, Program in Family Medicine, Vanderbilt
University, 1005 D.B. Todd Jr. Blvd., Nashville, TN 37208-3599,
rzoorob@mmc.edu
CDC collaborators
Nancy Cheal, MS, PhD, Acting Team Leader, FAS Prevention Team, DBDDD/NCBDDD/CDC, 1600 Clifton Road, MS E-86, Atlanta, GA 30333 404-498-6764, ncheal@cdc.gov
Elizabeth Dang, MPH, Behavioral Scientist, FAS Prevention Team, DBDDD/NCBDDD/CDC, 1600 Clifton Road, MS E-86, Atlanta, GA 30333 404-498-3947, edang@cdc.gov
Leanna Fox, MPH, Public Health Advisor, Prevention Research Branch, DBDDD/NCBDDD/CDC,1600 Clifton Road, MS E-86, Atlanta, GA 30333 404-498-0604, lfox1@cdc.gov
Catherine Hutsell, MPH, Health Education Specialist, FAS Prevention Team, DBDDD/NCBDDD/CDC, 1600 Clifton Road, MS E-86, Atlanta, GA 30333 404-498-3825, chutsell@cdc.gov
A. 9. Explanation of Any Payment or Gift to Respondents
This collection of information does not involve any payment or gift to respondents.
A. 10. Assurance of Confidentiality Provided to Respondents
This submission has been reviewed by the NCBDDD Privacy Officer, who determined that the Privacy Act does not apply.
This information collection involves anonymous data collection. Contact information is collected from participants on a voluntary basis for the purpose of communication with the FASD RTCs in general, and to allow contact for requesting participation in the follow-up assessments. However, the evaluation forms themselves will have no identifying information or any link to names or contact information. Rather, a code will be used to match evaluation forms over time. Descriptive summaries of the responses will be submitted to CDC. None of the contact information will be submitted to CDC.
IRB
Approval. This information collection has been determined not to
involve research.
Privacy Impact Assessment Information.
No identifying
information will be requested on any of the evaluation materials. All
data are collected and stored anonymously. Only the personnel
identified for each FASD Regional Training Center (identified in
section A.8.B) will have access to the data. Storage and retention of
data will be conducted in accordance with each FASD Regional Training
Center’s university policies. For the purpose of matching
surveys from pre- to post-test and follow-up assessments,
participants will be asked to create a code for their surveys. The
code will be something a participant can remember such as first
letter of mother’s maiden name, last digit of current address,
etc.
All participants are informed that completing the evaluation surveys is voluntary and anonymous and that the collected information will be used to improve future trainings.
A. 11. Justification for Sensitive Questions
No sensitive data will be collected.
A. 12. Estimates of Annualized Burden Hours and Costs
The information will be collected from the following types of respondents: Medical and allied health students, residents, and professionals/practitioners, training of trainer participants, academic faculty, training partners, and advisory committee members. Burden estimates are based on each FASD Regional Training Center’s projections of how many training participants they will reach annually and how long each evaluation instrument is estimated to take for a respondent to answer. As noted in the table of estimated annualized burden hours, each FASD Regional Training Center plans to use a variety of evaluation instruments, depending on the target audience and the training setting with the intent to evaluate their own training center’s activities. Each evaluation instrument also contains a core set of items that are the same across all FASD Regional Training Centers for assessing knowledge, practice behaviors, and comfort and self-efficacy to perform certain skills related to the prevention, identification, and treatment of FASDs. Through this manner, it will be possible to evaluate certain aspects of the collective FASD Regional Training Centers’ activities using consistent measures. See appendices for all proposed evaluation instruments.
It is estimated that 13,985 participants will be trained each year, for a total of 27,970 over the two year approval period. The total estimated annual burden is 2654 hours. There are no costs to respondents other than their time.
Estimated Annualized Burden Hours
Type of Respondents |
Organization
|
Form Name |
No. of Respondents |
No. of Responses per Respondent |
Avg. Burden/ Response
|
Total Burden (in hours) |
Medical and allied health professionals and students
|
Arctic RTC
|
Foundations Pre (C1) |
30 |
1 |
15/60 |
8 |
Foundations Post (C2) |
30 |
1 |
15/60 |
8 |
||
Foundations Follow-Up (C3) |
18 |
1 |
10/60 |
3 |
||
FASD 201 Pre (C4) |
30 |
1 |
10/60 |
5 |
||
FASD 201 Post (C5) |
30 |
1 |
10/60 |
5 |
||
FASD 201 Follow-Up (C6) |
18 |
1 |
10/60 |
3 |
||
Intro to FASDs Pre (C7) |
80 |
1 |
15/60 |
20 |
||
Intro to FASDs Post (C8) |
80 |
1 |
15/60 |
20 |
||
Intro to FASDs Follow-Up (C9) |
48 |
1 |
10/60 |
8 |
||
Train-the-Trainer Pre (C10) |
25 |
1 |
15/60 |
6 |
||
Train-the-Trainer Post (C11) |
25 |
1 |
15/60 |
6 |
||
Train-the-Trainer Follow-Up (C12) |
15 |
1 |
15/60 |
4 |
||
Online I Pre, Post (C13) |
100 |
2 |
10/60 |
33 |
||
Online II Pre, Post (C14) |
100 |
2 |
10/60 |
33 |
||
Online III Pre, Post (C15) |
100 |
2 |
10/60 |
33 |
||
Classroom and Special Event Post (C16) |
150 |
2 |
6/60 |
30 |
||
Nursing Students
|
Frontier RTC
|
Pre-test (D1) |
410 |
1 |
15/60 |
103 |
Post-test(D2) |
410 |
1 |
15/60 |
103 |
||
Follow-up(D3) |
410 |
1 |
15/60 |
103 |
||
Social Work Students
|
Pre-test (D4) |
410 |
1 |
15/60 |
103 |
|
Post-test(D5) |
410 |
1 |
15/60 |
103 |
||
Follow-up(D6) |
410 |
1 |
15/60 |
103 |
||
Allied Health Practitioners
|
Pre-test (D7) |
200 |
1 |
15/60 |
50 |
|
Post-test(D8) |
200 |
1 |
15/60 |
50 |
||
Follow-up(D9) |
200 |
1 |
15/60 |
50 |
||
Training of Trainers Participants |
Pre-test(D10) |
100 |
1 |
15/60 |
25 |
|
Post-test (D11) |
100 |
1 |
15/60 |
25 |
||
Follow-up(D12) |
100 |
1 |
15/60 |
25 |
||
Academic Faculty/ Students Online |
Pre-test(D13) |
150 |
1 |
15/60 |
38 |
|
Post-test(D14) |
150 |
1 |
15/60 |
38 |
||
Follow-up(D15) |
150 |
1 |
15/60 |
38 |
||
Practitioner Online
|
Pre-test(D16) |
160 |
1 |
15/60 |
40 |
|
Post-test(D17) |
160 |
1 |
15/60 |
40 |
||
Follow-up(D18) |
160 |
1 |
15/60 |
40 |
||
Medical and Allied Health Care Providers and Students
|
Great Lakes RTC
|
Foundations Pre-, QUALTRICS online Pre(E1) |
450 |
1 |
5/60 |
38 |
Foundations Post, QUALTRICS online Post(E2) |
450 |
1 |
10/60 |
75 |
||
Foundations 6-mo F/U, QUALTRICS online 6-Mo F/U (E3) |
310 |
1 |
5/60 |
26 |
||
Medical and Allied Health Care Providers and Students
|
SBI Pre, QUALTRICS online Pre(E4) |
120 |
1 |
8/60 |
16 |
|
SBI Post, QUALTRICS online Post(E5) |
120 |
1 |
13/60 |
26 |
||
SBI 6-mo F/U, QUALTRICS online 6-Mo Follow-up(E6) |
108 |
1 |
8/60 |
14 |
||
ID and Treatment of FASD Pre, QUALTRICS online Pre (E7) |
270 |
1 |
8/60 |
36 |
||
ID and Treatment of FASD Post, QUALTRICS online Post(E8) |
270 |
1 |
13/60 |
59 |
||
ID and Treatment of FASD 6-mo F/U, QUALTRICS online 6-Mo Follow-up(E9) |
258 |
1 |
8/60 |
34 |
||
FASD Comprehensive Pre, QUALTRICS online Comprehensive Pre (E10) |
220 |
1 |
15/60 |
55 |
||
FASD Comprehensive Post, QUALTRICS online Comprehensive Post (E11) |
220 |
1 |
20/60 |
73 |
||
FASD Comprehensive 6-mo F/U, QUALTRICS online Comprehensive 6-Mo Follow-up (E12) |
204 |
1 |
15/60 |
51 |
||
Physicians and Medical Students
|
Clinical Experience A(E13) |
25 |
1 |
5/60 |
2 |
|
Clinical Experience B(E14) |
25 |
1 |
5/60 |
2 |
||
Training of Trainers Participants |
Key Informant Interview (E15) |
16 |
1 |
15/60 |
4 |
|
Regional State Training Partners |
Key Informant Interview (E16) |
15 |
1 |
20/60 |
5 |
|
Advisory Committee Members |
Key Informant Interview (E17) |
10 |
1 |
15/60 |
3 |
|
Training of Trainer Participants |
Harvard Minute Feedback (E18) |
100 |
1 |
1/60 |
2 |
|
Staff and Training of Trainer Graduates |
Training Activity Reporting (TARF)(E19) |
180 |
1 |
2/60 |
6 |
|
Academic Faculty/ Health Professionals/ Professionals/ Health Profession Students |
Midwest RTC |
Knowledge Pre (F1) |
1080 |
1 |
7/60 |
126 |
Knowledge Post, 3 mo online F/U (F2) |
1080 |
2 |
7/60 |
252 |
||
Event Eval (F3) |
1110 |
1 |
5/60 |
93 |
||
Health Professionals
|
Continuing Education Event, Pre (F4) |
250 |
1 |
5/60 |
21 |
|
Continuing Education Event, Post (F5) |
250 |
1 |
5/60 |
21 |
||
Continuing Education Event, 3 mo online Follow-up (F6) |
250 |
1 |
5/60 |
21 |
||
Modified Index Pre, 3 mo online F/U (F7) |
75 |
2 |
10/60 |
25 |
||
Academic Faculty
|
Utilization of FAS/FASD Curriculum Pre, 3 mo online F/U (F8) |
50 |
2 |
5/60 |
8 |
|
Medical and allied health students and residents |
Southeast RTC |
FASD Pre (G1) |
500 |
1 |
10/60 |
83 |
FASD Post (G2) |
500 |
1 |
15/60 |
125 |
||
FASD 3 Mo online Follow-up (G3) |
300 |
1 |
10/60 |
50 |
||
TOTAL |
|
|
13,985 |
|
|
2654 |
Estimates of annualized cost to respondents
Estimates of annualized cost to respondents for the burden hours for collections of information were based on the hourly wage cost from the U.S. Department of Labor’s “May 2011 National Occupational Employment and Wage Estimates.” Because it is unknown what occupations a medical or allied health student or resident might have while in school/residency, the estimate for students/residents was based on the average for All Occupations. For rows pertaining to medical and allied health students/residents and professionals combined, the amount is based on an average of All Occupations and Healthcare Practitioners and Technical Occupations. For rows pertaining solely to medical and allied health professionals, the estimates are based on the Healthcare Practitioners and Technical Occupations category. Because it is unknown what occupation those in the categories of Training of Trainer participants/staff/graduates, Regional Training Center advisory committee members, and regional state training participants might have, estimates for those categories are based on the average for All Occupations. For rows pertaining to Academic Faculty, the estimates are based on the Health Specialties Teachers, Postsecondary category. See http://www.bls.gov/oes/current/oes_nat.htm
Estimated Annualized Burden Costs
Type of Respondents |
Organization
|
Form Name |
Total Burden Hours |
Avg. Hourly Rate |
Total Respondent cost |
Medical and allied health professionals and students
|
Arctic RTC
|
Foundations Pre |
8 |
$28.36 |
$226.88 |
Foundations Post |
8 |
$28.36 |
$226.88 |
||
Foundations Follow-Up |
3 |
$28.36 |
$85.08 |
||
FASD 201 Pre |
5 |
$28.36 |
$141.80 |
||
FASD 201 Post |
5 |
$28.36 |
$141.80 |
||
FASD 201 Follow-Up |
3 |
$28.36 |
$85.08 |
||
Intro to FASDs Pre |
20 |
$28.36 |
$567.20 |
||
Intro to FASDs Post |
20 |
$28.36 |
$567.20 |
||
Intro to FASDs Follow-Up |
8 |
$28.36 |
$226.88 |
||
Train-the-Trainer Pre |
6 |
$28.36 |
$170.16 |
||
Train-the-Trainer Post |
6 |
$28.36 |
$170.16 |
||
Train-the-Trainer Follow-Up |
4 |
$28.36 |
$113.44 |
||
Online I Pre, Post |
33 |
$21.74 |
$717.42 |
||
Online II Pre, Post |
33 |
$21.74 |
$717.42 |
||
Online III Pre, Post |
33 |
$21.74 |
$717.42 |
||
Classroom and Special Event Post |
30 |
$21.74 |
$652.20 |
||
Nursing Students
|
Frontier RTC
|
Pre-test |
103 |
$21.74 |
$2,239.22 |
Post-test |
103 |
$21.74 |
$2,239.22 |
||
Follow-up |
103 |
$21.74 |
$2,239.22 |
||
Social Work Students
|
Pre-test |
103 |
$21.74 |
$2,239.22 |
|
Post-test |
103 |
$21.74 |
$2,239.22 |
||
Follow-up |
103 |
$21.74 |
$2,239.22 |
||
Allied Health Practitioners
|
Pre-test |
50 |
$34.97 |
$1,748.50 |
|
Post-test |
50 |
$34.97 |
$1,748.50 |
||
Follow-up |
50 |
$34.97 |
$1,748.50 |
||
Training of Trainers Participants |
Pre-test |
25 |
$21.74 |
$543.50 |
|
Post-test |
25 |
$21.74 |
$543.50 |
||
Follow-up |
25 |
$21.74 |
$543.50 |
||
Academic Faculty/ Students Online |
Pre-test |
38 |
$21.74 |
$826.12 |
|
Post-test |
38 |
$21.74 |
$826.12 |
||
Follow-up |
38 |
$21.74 |
$826.12 |
||
Practitioner Online
|
Pre-test |
40 |
$34.97 |
$1,398.80 |
|
Post-test |
40 |
$34.97 |
$1,398.80 |
||
Follow-up |
40 |
$34.97 |
$1,398.80 |
||
Medical and Allied Health Care Providers and Students
|
Great Lakes RTC
|
Foundations Pre-, QUALTRICS online Pre |
38 |
$28.36 |
$1,077.68 |
Foundations Post, QUALTRICS online Post |
75 |
$28.36 |
$2,127.00 |
||
Foundations 6-mo F/U, QUALTRICS online 6-Mo F/U |
26 |
$28.36 |
$737.36 |
||
Medical and Allied Health Care Providers and Students
|
SBI Pre, QUALTRICS online Pre |
16 |
$28.36 |
$453.76 |
|
SBI Post, QUALTRICS online Post |
26 |
$28.36 |
$737.36 |
||
SBI 6-mo F/U, QUALTRICS online 6-Mo Follow-up |
14 |
$28.36 |
$397.04 |
||
ID and Treatment of FASD Pre, QUALTRICS online Pre |
36 |
$28.36 |
$1,020.96 |
||
ID and Treatment of FASD Post, QUALTRICS online Post |
59 |
$28.36 |
$1,673.24 |
||
ID and Treatment of FASD 6-mo F/U, QUALTRICS online 6-Mo Follow-up |
34 |
$28.36 |
$964.24 |
||
FASD Comprehensive Pre, QUALTRICS online Comprehensive Pre |
55 |
$28.36 |
$1,559.80 |
||
FASD Comprehensive Post, QUALTRICS online Comprehensive Post |
73 |
$28.36 |
$2,070.28 |
||
FASD Comprehensive 6-mo F/U, QUALTRICS online Comprehensive 6-Mo Follow-up |
51 |
$28.36 |
$1,446.36 |
||
Physicians and Medical Students
|
Clinical Experience A |
2 |
$28.36 |
$56.72 |
|
Clinical Experience B |
2 |
$28.36 |
$56.72 |
||
Training of Trainers Participants/ Regional State Training Partners/ Advisory Committee Members |
Key Informant Interview |
4 |
$21.74 |
$86.96 |
|
Key Informant Interview |
5 |
$21.74 |
$108.70 |
||
Key Informant Interview |
3 |
$21.74 |
$65.22 |
||
Training of Trainer Participants |
Harvard Minute Feedback |
2 |
$21.74 |
$43.48 |
|
Staff and Training of Trainer Graduates |
Training Activity Reporting (TARF) |
6 |
$21.74 |
$130.44 |
|
Academic Faculty/ Health Professionals/ Professionals/ Health Profession Students |
Midwest RTC |
Knowledge Pre |
126 |
$28.36 |
$3,573.36 |
Knowledge Post, 3 mo F/U |
252 |
$28.36 |
$7,146.72 |
||
Event Eval |
93 |
$28.36 |
$2,637.48 |
||
Health Professionals
|
Continuing Education Event, Pre |
21 |
$34.97 |
$734.37 |
|
Continuing Education Event, Post |
21 |
$34.97 |
$734.37 |
||
Continuing Education Event, 3 mo Follow-up |
21 |
$34.97 |
$734.37 |
||
Modified Index Pre, 3 mo online F/U |
25 |
$34.97 |
$874.25 |
||
Academic Faculty
|
Utilization of FAS/FASD Curriculum Pre, 3 mo online F/U |
8 |
$47.69 |
$381.52 |
|
Medical and allied health students and residents |
Southeast RTC |
FASD Pre |
83 |
$28.36 |
$2,353.88 |
FASD Post |
125 |
$28.36 |
$3,545.00 |
||
FASD 3 Mo Follow-up |
50 |
$28.36 |
$1,418.00 |
||
TOTAL |
$71,459.74 |
||||
A. 13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers
There are no other annual cost burdens to respondents or record keepers.
A. 14. Annualized Cost to the Government
The average annualized cost to the Government is $927,463. The project involves the CDC Project Officer, who is responsible for the programmatic approach and project oversight including guidance of the educational outreach planning efforts as well as the planning and review of all information collection involved. The effort of the CDC public health advisor will be required for fiscal and managerial tasks. For the grantee, the majority of costs are involved in the development, coordination, and implementation of the trainings, including travel cost.
|
Total ($) |
||
Federal Government Personnel costs |
CDC Project Officer GS13 (.10 FTE) |
$11,115 |
|
CDC Public Health Advisor GS12 (.05 FTE)
|
$4,074 |
||
Grantee Direct Labor |
Arctic RTC
Great Lakes FASD Regional Training Center
Frontier FASD Regional Training Center
Midwestern FASD Regional Training Center
Southeastern FASD Regional Training Center
|
$33,583 $49,826 $27,747 $4,478 $8,199 $1,610 $125,443 $48,045
$64,000 $10,822 $41,600 $6,861 $123,283 $54,244
$23,805 $22,005 $21,764 $6,750 $7,784 $4,088 $6,000 $4,711 $7,226 $4,215 $9,803 $118,151 $29,442
$15,842 $8,074 $10,248 $2,732 $4,763 $41,659 $12,539
$9,750 $7,000 $4,525 $2,625 $4,800 $48,000 $23,920 $6,900 $107,520 $26,988 |
|
Total Grantee Personnel Cost |
|
|
$687,314 |
Other Grantee Direct Cost |
Supplies
Travel and Subsistence
Other Costs
|
$11,200 $1,200 $9,200 $0 $2,430
$6,859 $14,403 $8,000 $6,700 $19,925
$31,118 $36,750 $16,800 $30,538 $29,837
|
|
Total Other Grantee Direct Cost |
|
|
$224,960 |
Total Cost |
|
|
$927,463 |
A. 15. Explanation for Program Changes or Adjustments
This is a new data collection.
A. 16. Plans for Tabulation and Publication and Project Time Schedule
The descriptive data collected will be summarized to inform FASD Regional Training Center planning activities and to improve future programs. This information is for internal use only and will not be published. Summary reports on the findings will be submitted to CDC as part of mid-year, annual, and final reports.
The project timeline is summarized here:
A.16.—Project Time Schedule |
||
|
||
Activity |
Timeframe |
|
Identify and invite participants to trainings |
Identify venues and organizations for trainings |
Starts 1–2 months after OMB approval, ongoing |
Identify and invite participants |
Starts 1–2 months after OMB approval, ongoing |
|
Conduct trainings |
Deliver training |
Starts 1–2 months after OMB approval, ongoing |
Conduct post-surveys |
Starts 1–2 months after OMB approval, ongoing |
|
Conduct follow-up survey |
3-6 months after each training (depending on RTC’s evaluation design) |
|
Analyze and Report Data |
Draft Report |
Semi-annual, with progress report (mid-year) and annual report (end of year) |
Final Report |
At end of budget period |
|
For the reports, data will be summarized across respondents. For rating and categorical scales, the percent of each answer chosen compared to the total number of answers given will be reported per item. Open ended questions will be reviewed and summarized by themes.
A. 17. Reason(s) Display of OMB Expiration Date is Inappropriate
The OMB expiration date will be displayed.
A. 18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.
References
Anderson, B.L., Dang, E.P., Floyd, R.L., Sokol, R., Mahoney, J., Schulkin, J. (2010). Knowledge, opinions, and practice patterns of obstetrician-gynecologists regarding their patients’ use of alcohol. Journal of Addiction Medicine 4(2): 114–121.
Centers for Disease Control and Prevention (2002). National Task Force on Fetal Alcohol Syndrome and Fetal Alcohol Effect --- Defining the national agenda for fetal alcohol syndrome and other prenatal alcohol-related effects. MMWR Morbidity and Mortality Weekly Report Recommendations and Reports 51(RR14): 9-12.
Diekman, S.T., Floyd, R.L., Decoufle, P., Schulkin, J., Ebrahim, S.H., Sokol, R.J. (2000). A survey of obstetrician-gynecologists on their patients' alcohol use during pregnancy. Obstetrics & Gynecology 95: 756-763.
Gahagan, S., Sharpe, T.T., Brimacombe, M., Fry-Johnson, Y., Levine, R., Mengel, M., O’Connor, M., Paley, B., Adubato, S., Brenneman, G. (2006). Pediatricians’ knowledge, training, and experience in the care of children with fetal alcohol syndrome. Pediatrics 118(3): e657-e668.
Stratton, Kathleen, Howe, Cynthia, Battaglia, Frederick, editors (1996). Fetal Alcohol Syndrome: Diagnosis, Epidemiology, Prevention and Treatment. Institute of Medicine. Washington, D. C., National Academy Press.
U.S. Department of Health and Human Services (2000). 10th Special Report to Congress on Alcohol and Health. Highlights from Current Research. “Prenatal Alcohol Exposure: effects on Brain Structure and Function”. 285-299.
U.S. Department of Health and Human Services. Office of Disease Prevention and Health Promotion (2011). Healthy People 2020. Washington, DC. Available at http://www.healthypeople.gov/2020/. Accessed 4/4/2012.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | On January 9, 2009, CDC received OMB approval for the generic concept of health marketing (Health Marketing, 0920-0798) to provi |
| Author | bmm1 |
| File Modified | 0000-00-00 |
| File Created | 2021-01-30 |