09s0-0222 GenIC Request Template / SSA

Supporting Statement A for Request for Clearance:

COLLABORATING CENTER FOR QUESTIONNAIRE DESIGN AND EVALUATION RESEARCH

National Intimate Partner and Sexual Violence (NISVS)Traumatic Brain Injury

OMB No. 0920-0222

Expiration Date: 01/31/2026

Contact Information:

Amanda Titus

Behavioral Scientist, Collaborating Center for Questionnaire Design and Evaluation Research

Division of Research and Methodology

National Center for Health Statistics/CDC

3311 Toledo Road, Room 5451

Hyattsville, MD 20782

301-458-4579

[email protected]

December 8, 2023

Table of Contents

1. Justification

A.1. Circumstance Making the Collection of Information Necessary 2

A.2. Purpose and Use of Information Collection 2

A.10. Protection of the Privacy and Confidentiality of Information Provided

by Respondents……………………………………………. 3

A.11. Institutional Review Board (IRB) and Justification for Sensitive Questions 4

A.12. Estimates of Annualized Burden Hours and Costs 4

LIST OF ATTACHMENTS

Attachment 1: Questions

Attachment 2: Previous use and Development of Questions

Attachment 3: Advertisement

Attachment 4: Screening Script

Attachment 5: Informed Consent

Attachment 6: Respondent Distress Guide

Attachment 7: Interviewer Distress Guide

Attachment 8: Secondary Trauma Training

A. JUSTIFICATION

1. Circumstances Making the Collection of Information Necessary

The NCHS Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER) conducts qualitative and mixed method research. CCQDER data collection is authorized under a generic OMB clearance (OMB No. 0920-0222, Exp. Date 01/31/2026) and 42 U.S.C. 242k (Section 306 of the Public Health Service Act).

2. Purpose and Use of Information Collection

CCQDER conducts exploratory question evaluation studies, for both applied and methodological purposes, with particular focus on question design, measurement, comparability, and response error.

The purpose of the current project is to evaluate the construct validity of questions on intimate partner violence resulting in traumatic brain injury for CDC’s National Center for Injury Prevention and Control (NCIPC). The questions will be tested on 20 English speaking respondents and are included as Attachment 1.

Previous use and development of these items are included as Attachment 2. NCHS understands that OMB approval for evaluation of these questions does not imply or guarantee future approval for use or application of these or similar items.

The methodological plan for this study is consistent with that of most NCHS/CCQDER cognitive interviewing studies, that is, to understand the construct captured by each question, identify any patterns of interpretation across respondent groups, and explore potential sources of response error. The testing procedure conforms to the cognitive interviewing techniques that have been described in CCQDER’s generic clearance package (OMB No. 0920-0222, exp. 01/31/2026).

Within that framework, the following procedures are particular to this study:

Recruitment. We propose to recruit up to 20 English speaking adults (18 and over) who 1) have experienced intimate partner or sexual violence in general or 2) have experienced head injuries as a result of intimate partner violence. In addition, because demographic diversity, equity, and intersectionality is also a priority, the purposive sample will aim to include a mix of genders, age, race, and educational attainment.

Recruitment will be carried out through a combination of advertisements, flyers, word-of-mouth, and the CCQDER Respondent Database. The advertisement/flyer used to recruit respondents is shown in Attachment 3.

Screening. Respondent screening will conform to the protocol laid out in CCQDER’s generic package. The 5-minute screener used to determine eligibility of individuals responding to the advertisements/flyers is shown in Attachment 4. It is anticipated that as many as 40 individuals may need to be screened to recruit 20 participants.

Interview methods. Cognitive interviews will be conducted by CCQDER staff in accordance with the protocol described in CCQDER’s generic package. The informed consent documents specific to this project are included as Attachment 5.

Note: Some documents associated with this project do not vary from those approved in CCQDER’s generic OMB package and are, therefore, not included as attachments to this document. These documents are the Respondent Data Collection Sheet, the Thank you Letter, CCQDER’s Data Storage and Access Policy and the Nondisclosure Affidavit.

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

The CCQDER continues to collect, on a confidential basis, data needed in order to conduct CCQDER studies. Confidentiality provided to respondents is assured by adherence to Section 308(d) of the Public Health Service Act (42 U.S.C. 242m).

Confidentiality of responses and safeguarding of data at NCHS

The CCQDER has a routine set of administrative, technical, and physical measures to safeguard confidentiality. Specific protocol for storage of confidential data, QDRL Lab, Q-video, Q-Notes, and Q-Bank access is described in CCQDER’s generic clearance package. (OMB No. 0920-0222, exp. 01/31/2026)

Records Retention Schedule for Cognitive Interviews

Storage and retention of CCQDER data is guided by the CCQDER Data Storage and Access Policy which governs retention of interviews, their viewing audience, the data kept, and the length of time before retention of interviews is reassessed. The Data Storage and Access Policy has been approved by the NCHS ERB and is included in CCQDER’s generic OMB package. In accordance with this policy, data from the current project will be re-evaluated by the CCQDER Director to determine relevance, ongoing usefulness and qualitative value for likely use in question evaluation research after an initial retention period of 2 years. The information of individuals who did not qualify for the study and opt into our respondent database will be kept for 5 years. Removal from our database can be requested by emailing [email protected].

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

NCHS and CDC Institutional Review Board (IRB) approved this data collection on 12/01/2023.

NCHS ERB requested CCQDER provide support for distress caused by the sensitive nature of the questions. Although it is difficult to anticipate which, if any, questions may cause undue stress for a particular respondent, the topic under investigation is potentially sensitive and questions may cause anxiety if a person has had a difficult experience. Only senior-level, highly skilled interviewers will be assigned to the project. All interviewers will be instructed on how to identify possible signs of distress in respondents, such as fidgeting, change in tone of voice or non-responsiveness, and what to do if this occurs depending on the level of any stress displayed, which may culminate in terminating the interview. Interviewers will be able to provide the distressed respondent with support in the form of help lines they can call and web resources, including the National Suicide hotline and the National Child Abuse hotline as listed on the CDC website. See Attachment 6 for respondent distress guidance, hot lines, and web resources. The CCQDER operations team lead for the study and the study Principal Investigator will be informed of any signs of distress displayed during the interview. The operations team lead will be responsible for immediately reporting to the NCHS ERB all cases of moderate and severe distress, and all mild distress cases who either (a) chose to stop the interview before it was complete (for any reason, whether they give a reason or not), or (b) asked for appropriate helpline and/or web resources, or these were offered by the interviewer at any time during or after the interview. All CCQDER interviewers have received additional training from the Worklife Wellness Office (WWO) on recognizing Secondary Trauma and were provided with an Interviewer Distress Guide (Attachment 7) that details resources to handle distress they may experience, and WWO training slides (Attachment 8).

12. Estimates of Annualized Burden hours and costs (Table 1 was approved by OMB on January 31, 2023, for CCQDER’s Generic data collection, OMB No. 0920-0222)

Table 1: Estimated Annualized Burden Table: (Approved hours under OMB No. 0920-0222)

Types of Respondents	Form Name	Number of Respondents	Number of Responses per Respondent	Average hours per response (in hours)	Total Burden Hours
Individuals or households	Eligibility Screeners	4,400	1	5/60	367
Individuals or households	Developmental Questionnaires	8,750	1	55/60	8,021
Individuals or households	Respondent Data Collection Sheet	8,750	1	5/60	729
Total		9,190			9,117

Table 2: Burden table for the NISVS Project:

Form Name	Number of Participants	Number of Responses/Participants	Average hours per response	Response Burden (in hours)
Screener (all recruitment methods as described above (Attachment 4)	40	1	5/60	3.33
Questionnaire	20	1	55/60	18.3
Respondent Data Collection Sheets	20	1	5/60	1.6
Total				23.23