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[OS] CDC/ATSDR Formative Research and Tool Development

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OMB: 0920-1154

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Generic Clearance for CDC/ATSDR

Formative Research and Tool Development

OMB# 0920-1154







Title: Adverse Childhood Experiences Prevention Message Development





Supporting Statement A







July 26, 2024







Contact Information:

Brooke Aspinwall

NCIPC

















Table of Contents

List of Attachments

Attachment 1: ACEs Survey and Consent

Attachment 2: ACEs Survey Screenshots

Attachment 3: ACEs Focus Group Participant Screener

Attachment 4: ACEs Focus Group Consent Form

Attachment 5: ACEs Focus Group Guide

Attachment 6: ACEs Partner Interview Consent Form

Attachment 7: ACEs Partner Interview Guide

Attachment 8: ACEs Messages for Testing

Attachment 9: Privacy Impact Assessment

Attachment 10: STARS Non-Research determination



Goal of the study: We will conduct formative research to collect information on the audiences’ perceptions and understanding about messages and concepts related to adverse childhood experiences (ACEs) and their prevention, messaging preferences, and trusted messengers and dissemination channels. This project aims to enhance CDC’s ability to develop messages about ACEs.

Intended use of the resulting data: We will use the data collected to refine or revise messages about ACEs prevention for general consumers/trusted adults, parents/caregivers, direct service providers, and CDC partners. We will also use these data to craft recommendations for communication assets, and plan communication and dissemination strategies.

Data collection methods: Data collection will include a survey of 200 participants, virtual focus groups with 24 participants, and interviews with 5 participants. All materials comply with OMB’s SPD-15

The subpopulation to be studied: Adults, defined as people who interact with children and youth (e.g., youth sports coaches, mentors, neighbors, family); parents and caregivers; direct service providers, defined as people who work with children (e.g., child care providers, teachers, housing organizations, child welfare, substance abuse and mental health providers); and one CDC partners (e.g., federal agencies like the Department of Education, state health departments, policy organizations, advocacy organizations).

How data will be analyzed: Quantitative data from the survey will be analyzed using descriptive statistics. Qualitative data will be analyzed using thematic analysis strategies to answer the research questions and identify findings which will be translated into communication and dissemination strategies. For both focus group data analysis and interview data analysis, a codebook will be developed with deductive and inductive codes to identify and compare themes within and across focus groups, as well as within and across interviews.





  1. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

The Centers for Disease Control and Prevention (CDC) requests OMB approval of a new generic information collection (GenIC) under the generic information collection entitled Generic Clearance for CDC/ATSDR Formative Research and Tool Development for a period of 12-months.

Adverse childhood experiences (ACEs) are potentially traumatic events that occur in childhood such as exposure to violence, abuse or neglect, witnessing violence in the community, and substance abuse problems. ACEs can have lingering negative effects on a person’s health and well-being, and more than 50% of U.S. adults have experienced at least one type of ACE before the age of 18 (CDC, 2023). These data constitute ACEs as a public health problem. However, ACEs can be prevented through evidence-based strategies and approaches. Both CDC’s National Center for Injury Prevention and Control (NCIPC) and its Division of Violence Prevention (DVP) have prioritized preventing ACEs throughout the United States.

CDC’s mission outlines key activities to prevent violence and its consequences, including surveillance, research and development, capacity building, communication, and leadership. To successfully carry out these activities, CDC and its partners must understand the fundamental building blocks of violence prevention, including concepts of primary prevention, the social-ecological model, and the public health approach. To build upon these fundamentals, CDC must reach key audiences with relevant and actionable information related to high-priority topics like ACEs. To achieve violence prevention objectives and reach priority populations, CDC must test and tailor the messages, language, imagery, and assets it uses according to the best available evidence. Clear, actionable messages in plain language for consumer audiences is also a key component of CDC’s larger Moving Forward and Clean Slate initiatives. The findings from this formative research and resulting messages will be disseminated in various communication products, technical assistance materials, tools, and trainings.

2. Purpose and Use of Information Collection

The information collected for this qualitative formative testing will be used to enhance CDC’s ability to develop messages about ACEs. CDC can understand key audiences’ knowledge and barriers to receiving information about ACEs prevention by conducting research that collects information on key audiences’ awareness and understanding of ACEs, knowledge and perceptions of ACEs prevention strategies, perceived role in ACEs prevention, preferred communication channels and trusted messengers. This data collection will allow CDC to test draft messages about ACEs prevention (Attachment 8), to inform the development of messages and concepts that can increase awareness and understanding of ACEs prevention and support the health and well-being of children and families.

A survey will be conducted online using the online survey platform Survey Monkey. Using Survey Monkey will allow a national recruitment approach through existing participant panels on the survey platform. A national recruitment approach will reach wider audiences, particularly those who are harder to reach, including those in rural areas.

Focus groups and interviews will be conducted online via the online video-conferencing platform Zoom. Virtual focus groups and interviews not only allow national recruitment to wider audiences, but also provide flexibility for participants who would not be able to attend in-person focus groups or interviews. Each focus group or interview will be audio-recorded and data will be transferred and stored on a shared information system with access restricted to authorized study personnel. Each focus group or interview will be transcribed and imported into Atlas.ti 23 for coding. The use of a transcription service allows the research team to process and analyze the data quickly and monitor for data saturation. All materials comply with OMB’s SPD-15.

3. Use of Information Technology and Burden Reduction

To minimize respondent burden, surveys will be administered electronically through a respondent-friendly administration process. 100% of survey data will be collected electronically. To minimize respondent burden and reduce potential participation barriers (e.g., travel time or cost for in-person data collection activities), focus groups and interviews will be conducted virtually.

4. Efforts to Identify Duplication and Use of Similar Information

CDC is the lead federal agency working across sectors on comprehensive approaches for preventing ACEs. Health messages developed by CDC are unique in their mix of the intended audience, health behavior, concept, and execution. The CDC National Center for Injury Prevention and Control submitted a previous generic collection request for “Child Abuse and Neglect Prevention Message Development (CAN)”, which was approved by OMB on 2/13/2024 under “Generic Clearance for CDC/ATSDR Formative Research and Tool Development” (OMB# 0920-1154), that specifically focuses on messaging related to prevention of child abuse and neglect (CAN), which is a type of ACE. However, the information collected in this generic request will focus on messaging related to ACEs and ACEs prevention. A literature review found no instances of similar information to be available.

5. Impact on Small Businesses or Other Small Entities

This data collection will not involve small businesses.

6. Consequences of Collecting the Information Less Frequently

This request is for a one-time data collection.

7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5

This request fully complies with the regulation 5 CFR 1320.5

8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the Agency

A.8.a) Federal Register Notice

A 60-day Federal Register Notice has already been published for the Generic Clearance. No Federal Register Notice is required for this GenIC submission.

A.8.b) Efforts to Consult Outside the Agency

CDC consulted with several CDC and outside experts to provide input as listed below.


Name

Affiliation

Tessa Burton

CDC

Brooke Aspinwall

CDC

Carmen Goman

CDC

Sarah Roby

CDC

Apeksha Iyer

Banyan Communication

Sharanya Thummalapally

Banyan Communications

Liz Ferguson

Banyan Communications

Bria Berry

Banyan Communication



9. Explanation of Any Payment or Gift to Respondents



Incentives will not be offered directly to survey participants. Each focus group and interview participant will receive $75 in the form of a gift card as a token of appreciation. Providing incentives to respondents is necessary to successfully recruit individuals. Incentives can increase the likelihood of obtaining a diverse sample of participants, which would include individuals in hard-to-reach and minority populations who encounter complex social problems that place limitations on their desire and time to volunteer for research studies (Ellard-Gray et al. 2015; Knoll et al. 2012).

Other approved OMB Information Collection Request (ICR) detailing similar focus group designs have offered $75-100 in incentives to focus group participants (OMB# 0920-0572, OMB# 0920-0800), including generic request under this current Formative Research mechanism (OMB# 0920-1154). Qualitative research can be time-intensive, and incentives are often used to support expenses related to transportation, time away from work, and arrangements for childcare (OMB # 0920-0840). The COVID-19 pandemic provided novel opportunities for hosting online focus groups. While offering online opportunities for participation might have removed transportation costs, other challenges like taking time away from work or arranging for childcare persist if individuals are to devote their full attention to participation in the discussion. Furthermore, while the shift to online data collection improved response rates among younger, technologically-savvy generations, as well as those with the income to afford the required technology, individuals from lower-income households, with limited access to the internet or computers, and the lower levels of digital literacy, are still less likely to participate. Based on their experience conducting online interviews with African Americans from low SES backgrounds, Lathen & Laestadius (2021) found that “participants wanted and needed to receive financial incentives in real-time, especially because of loss of income during the COVID pandemic.” They suggested investigators consider increasing the incentive for participation in the virtual focus groups to help offset both participation costs and the loss of other incentives previously received in person.



10. Protection of the Privacy and Confidentiality of Information Provided by Respondents

This submission has been reviewed by the NCIPC’s Information Systems Security Officer, who has determined that the Privacy Act does not apply (Att. 9). The proposed study does not involve the collection of personally identifiable information (PII) or sensitive data. No questions will be asked that are of a personal or sensitive nature. CDC will not have access or receive potentially identifiable information. Survey participants will be assigned a participant ID number and will not disclose any personally identifiable information (PII) to the study team through their responses. Focus group participants will be asked to provide their first name only or a “nickname” instead of their full name to avoid collecting PII. Focus group participants will only be asked to provide an email address that the professional recruiter may use to contact them, but the professional recruiter will not share email addresses with study personnel. All procedures have been developed, in accordance with federal, state, and local guidelines.

11. Institutional Review Board (IRB) and Justification for Sensitive Questions

IRB Approval

The CDC National Center for Injury Prevention and Control’s OMB and human subject’s liaison has determined that IRB approval is not needed for this non-research activity (Att. 10).

Sensitive Questions

This data collection does not require participants to answer questions of a sensitive nature.

12. Estimates of Annualized Burden Hours and Costs

Recruitment for the general population survey will be conducted through SurveyMonkey (Attachment 1 and 2). The survey will take 15 minutes total per individual to complete.

The general consumers/trusted adults and parents/caregivers audiences will be recruited for focus groups through a professional recruitment firm. The direct service providers audience will be recruited for focus groups through CDC contacts at organizations like Prevent Child Abuse America (PCAA) and existing CDC channels like the VetoViolence Digest. The screening form (Attachment 3) is estimated to take about 2 minutes per individual to complete, as well as the consent (Attachment 4). Each focus group will take 60 minutes (Attachment 5).

Recruitment for the interviews with CDC partners (5 participants) will occur via CDC’s existing networks. The consent (Attachment 6) is estimated to take about 2 minutes, and each interview will take 60 minutes (Attachment 7).

Draft messages about ACEs prevention (Attachment 8) will be tested in the survey, focus groups, and interviews.

There is no cost to survey, focus group, or interview participants beyond the participation burden time.

The table below provides the burden estimates for this study.

Table 1. Estimated Annualized Burden Hours

Types of Respondents

Form Name

No. of Respondents

Average Burden per Response (in hours)

Total Burden (in hours)

General Consumers/Trusted Adults, Parents/Caregivers, Direct Service Providers, and CDC Partners

Survey and Consent (Att. 1)

200

15/60

50

Focus Group Participant Screener (Att. 3)

60

5/60

5

Focus Group Consent (Att. 4)

24

2/60

1

Focus Group Guide (Att. 5)

24

1

24

Partner Interview Consent (Att. 6)

5

2/60

1

Partner Interview Guide (Att.7)

5

1

5

Total




86



12b. The estimates of the annualized cost to respondents for the burden hours for the collection of information is derived from the 2023 mean hourly wage of $31.48 across all occupations, per the U.S. Department of Labor (DOL) May 2023 (the most up-to-date non-provisional data) National Occupational Employment and Wage Estimates.

Table 2. Estimated Annualized Burden Costs

Type of Respondents

Form Name

Total Burden Hours

Hourly Wage Rate

Total Respondent Costs

General Consumers/Trusted Adults, Parents/Caregivers, Direct Service Providers, and CDC Partners

Survey and Consent (Att.1)

50

$31.48

$1574

Focus Group Participant Screener (Att. 3)

5

$31.48

$157.40

Focus Group Consent (Att. 4)

1

$31.48

$31.48

Focus Group Guide (Att. 5)

24

$31.48

$755.52

Partner Interview Consent (Att. 6)

1

$31.48

$31.48

Partner Interview Guide (Att. 7)

5

$31.48

$157.40

Total



$2707.28



13. Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers

This data collection does not involve other annual cost burdens to respondents or record keepers.


14. Annualized Cost to the Government

The contractor’s costs are based on estimates provided by the contractor, who will carry out the data collection activities. With the expected period of performance, the annual cost to the federal government is estimated to be $44,520.00 (Table 3). This is the cost estimated by the contractor and includes the estimated cost of coordination with CDC, data collection, analysis, and reporting.


Table 3. Annualized Costs to the Government

Description of Services

Estimated Annualized Cost

Contractor costs for labor, data collection, and other overhead costs, per contract year

$44,520.00

Total Annual Cost

$44,520.00


15. Explanation for Program Changes or Adjustments

No change in burden is requested, as this is a new information collection.

16. Plans for Tabulation and Publication and Project Time Schedule

All activities for the project are expected to be completed within 12 months. One year of clearance is being requested for research activities. Table 4 outlines the project schedule.

Table 4. Project Timeline

Project Time Schedule

Activity

Time Schedule

Conduct survey

Immediately upon OMB approval

Focus Group Recruitment

Within 4 months of OMB approval

Conduct focus groups

Within 4 months of OMB approval

Coding and thematic analysis

Within 6 months of OMB approval

Reporting and synthesis of findings

Within 6 months of OMB approval



17. Reason(s) Display of OMB Expiration is Inappropriate

None; The display of the OMB expiration date is not inappropriate.

18. Exceptions to Certification for Paperwork Reduction Act Submissions

None; There are no exceptions to the certification.









References

Centers for Disease Control and Prevention (CDC). (2023, June 29). Fast Facts Preventing Adverse Childhood Experiences. https://www.cdc.gov/violenceprevention/aces/fastfact.html

Ellard-Gray, A., Jeffrey, N. K., Choubak, M., & Crann, S. E. (2015). Finding the Hidden Participant: Solutions for Recruiting Hidden, Hard-to-Reach, and Vulnerable Populations. International Journal of Qualitative Methods, 14(5), 1609406915621420. https://doi.org/10.1177/1609406915621420

Knoll, M., Soller, L., Ben-Shoshan, M. et al. The use of incentives in vulnerable populations for a telephone survey: a randomized controlled trial. BMC Res Notes 5, 572 (2012). https://doi.org/10.1186/1756-0500-5-572

Lathen, L., & Laestadius, L. (2021). Reflections on Online Focus Group Research With Low Socio-Economic Status African American Adults During COVID-19. International Journal of Qualitative Methods, 20, 16094069211021712. https://doi.org/10.1177/16094069211021713




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