Supporting Statement A for
Self-Affirmation Construct Validity (NCI)
March 7, 2016
Rebecca A. Ferrer, PhD
Behavioral Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
9609 Medical Center Drive MSC 9761
Room 3E238
Bethesda MD 20892-7344
Phone: 240-276-6914
Fax: 240-276-7906
Check off which applies:
X New
Revision
Reinstatement with Change
Reinstatement without Change
Extension
Emergency
Existing
List of Attachments
Attachment A – Selected Readings
Attachment B – Screenshots
B1- Survey Screenshot
B2- Screener Screenshot
Attachment C – IRB Approval
Attachment D – Privacy Act Memo
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 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 Agency
A.9 Explanation of Any Payment of Gift to Respondents
A.10 Assurance of Confidentiality Provided to Respondents
A.11 Justification for Sensitive Questions
A.12 Estimates of Hour Burden Including Annualized Hourly Costs
A.13 Estimate of Other Total Annual Cost Burden to Respondents or 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
A. Justification
This is a new information collection seeking approval for 3 years. This information collection, seeks to refine a theory about how self-competence and values play a role in defensive responses to health communications. Although theoretically-driven research has shown that self-affirmation – a process by which individuals reflect on values that are important to them – can improve responses to health and cancer communications, the “active ingredient” (or mechanisms underlying effectiveness) of self-affirmations is unknown. Self-affirmation is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. Understanding the mechanisms that explain these robust effects would yield evidence important for dissemination, including ways to refine self-affirmation interventions and make them more potent, which could change the ways that public health messages are constructed. This research can inform NCI scientific priorities and investments in self-affirmation research. The results of the information collection will be used to further develop and improve self-affirmation theory. These findings may allow future researchers to develop and test cancer prevention interventions.
A.1 Circumstances Making the Collection of Information Necessary
The National Cancer Institute’s (NCI) Behavioral Research Program (BRP), within the Division of Cancer Control and Population Sciences (DCCPS), initiates, supports, and evaluates a comprehensive program of research ranging from basic behavioral research to the development, testing, and dissemination of cancer prevention and control interventions. The goal of BRP is to increase the breadth, depth, and quality of behavioral research in cancer prevention and control. BRP conducts varying programs of formative research to develop and validate cancer-related behavioral theories. This NCI office is requesting that OMB review this sub-study, which describes a voluntary, low-burden, non-controversial, formative behavioral research project related to theory development and validation. Data collection for this project is authorized under 42 USC § 285 and 285a-1 (Section 410 and 412 of the Public Health Service Act).
This information collection is formative research related to further developing, refining, and testing a theory related to self-processing and defensiveness in the context of cancer risk information.
In this information collection, we plan to refine a theory about how self-competence and values play a role in defensive responses to health communications. Although theoretically-driven research has shown that self-affirmation – a process by which individuals reflect on values that are important to them – can improve responses to health and cancer communications, the “active ingredient” (or mechanisms underlying effectiveness) of self-affirmations is unknown (see selected readings Attachment A).
Self-affirmation is a potent means of augmenting the effectiveness of threatening health communications. Individuals tend to be defensive against information suggesting their behavior puts them at risk for disease or negative health. Previous evidence suggests that self-affirmation may reduce defensiveness to threatening health information, increasing openness to the message and resulting in increased disease risk perceptions, disease-related worry, intentions to engage in preventive behavior, and actual behavioral change. Understanding the mechanisms that explain these robust effects would yield evidence important for dissemination, including ways to refine self-affirmation interventions and make them more potent, which could change the ways that public health messages are constructed. Thus, we aim to elucidate potential mechanisms underlying the effectiveness of self-affirmation, including self-activation, general affirmation, and domain-specific affirmation.
Participants will complete a screener (Attachment B2), and if they meet inclusion criteria (women who drink more than seven alcoholic drinks per week), will be randomly assigned to one of eleven affirmation, self- activation, or other-activation conditions. Following the affirmation or activation task, subjects will read about the documented link between alcohol and breast cancer. Finally, they will be asked a series of questions about their intentions to reduce drinking, their perceived risk of breast cancer, and their worry about breast cancer. (see full study screenshots, Attachment B1) Drawing on previous research, we hypothesize that inductions will be effective to the degree that they involve a self-affirmation, but will not be effective if they involve only other-affirmation or self-activation.
This research can inform NCI scientific priorities and investments in self-affirmation research. The results of the information collection will be used to further develop and improve self-affirmation theory. We will disseminate our findings to relevant audiences –health psychologists/ public health researchers who capitalize on basic psychological science advances to develop efficacious health communications and interventions, and basic psychological scientists who study self-affirmation and affective experiences. Thus, these findings may allow future researchers to develop and test cancer prevention interventions.
A.3 Use of Information Technology and Burden Reduction
The modules will be administered to respondents electronically, through an online information-collection platform called Amazon Mechanical Turk (mTurk; wwww.mturk.com). mTurk is an internet service that allows researchers to collect survey data in a quick fashion minimizing the burden for respondents. The use of this online information-collection platform will decrease the response burden to the respondent, eliminate the need for manual data entry, and eliminate the use of paper to collect information.
No similar information collection exists. We have searched both existing data collections and the scientific literature, and no data collecting exists that would answer questions about self-affirmation outlined here.
This is a one-time information collection.
There are no special circumstances relating to 5 CFR 1320.5
A 60 day Federal Register Notice was published in the Federal Register on January 14, 2016, Vol.81; pp. 1958. No comments were received.
We have not consulted with any outside agency on this project.
A.9 Explanation of Any Payment of Gift to Respondents
No remuneration will be provided for completing the screener, but participants will be remunerated $1 for participating in the survey. This amount of remuneration is standard for Amazon mTurk participant payment (see selected readings, Attachment A), and is consistent with remuneration offered in previously approved studies (0925-0645-06, expiry 12/31/14; 0925-0645-08), expiry 12/31/14. This amount will be issued by Amazon to participants’ mTurk “worker” accounts.
A.10 Assurance of Confidentiality Provided to Respondents
The information will be kept private to the extent that is allowed by law. No PII will be collected. The Privacy Act Coordinator determined that a PIA is not necessary. This project has been approved by the NCI Special Studies IRB (Attachment C).
The Privacy Act is not applicable as determined by the Privacy Act Memo (Attachment D).
A.11 Justification for Sensitive Questions
No PII will be collected. No sensitive questions will be asked. The format for the race and ethnicity used is based on the standards set by the Affordable Care Act, http://aspe.hhs.gov/datacncl/standards/ACA/4302/index.shtml.
A.12.1 Estimated Annualized Burden Hours
The total estimated annualized burden is 717 hours. We anticipate screening 10,000 individuals to reach 1100 that qualify for the study. The burden for the screener is estimated at 1 minutes. 1100 participants will complete the study and the estimated burden for the survey is 30 minutes.
Table A12-1. Estimates of Hour Burden
Form Name |
Types of Respondents |
Number of Respondents |
Number of Responses Per Respondent |
Average Burden (in Hours) |
Total Hour Burden |
Screener |
General Public |
10,000 |
1 |
1/60 |
167 |
Study |
General Public |
1100 |
1 |
30/60 |
550 |
Total |
|
10,000 |
11,100 |
|
717 |
A.12-2 Annualized Cost to respondents
The total cost to respondents is $16,010.61. This is calculated using labor calculations for all occupations. Labor information, obtained from http://www.bls.gov/oes/current/oes_nat.htm#00-0000, provides the average US hourly earnings of $22.33 for employees of all occupations (occupation code: 00-0000 occupation title “All Occupations”). Table A12-1 illustrates the measures respondents will be answering and the number of hours to complete each type.
Table A12-2. Cost to Respondents
Form Name |
Type of Respondent |
Total Burden Hours |
Wage Rate |
Respondent Cost |
Screener |
General Public |
167 |
$22.33 |
$3,729.11 |
Study |
General Public |
550 |
$22.33 |
$12,281.50 |
Total |
717 |
|
$16,010.61 |
|
A.13 Estimate of Other Total Annual Cost Burden to Respondents or Record Keepers
There are no capital costs, operating costs, or maintenance costs to report.
The total cost to the federal government is $6,328. The NCI GS-14 Program Office will be dedicating 5% of her total time to the project, engaging in oversight and administrative roles. Salary information for GS-level Program Officers can be obtained at: http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/2015/general-schedule/. The NCI CRTA Fellow will be dedicating 20% of her total time to the project by administering the survey, collecting, cleaning, and analyzing data, and writing up the results for publication. Salary information for NIH CRTA fellows can be obtained at: https://www.training.nih.gov/trainee_-_postdoc_faqs . Table A14-1 contains the annualized cost to the federal government
Table A14-1. Cost to the Federal Government
Source |
Task |
Annualized Cost |
NCI Staff |
NCI GS 14-5 Program Officer (5% of 22 weeks, annual salary $113,948) |
$2,411 |
NCI post-baccalaureate CRTA Fellow (20% of 22 weeks, annual salary $30,700) |
$2,597 |
|
Respondent Costs |
Incentives |
$1,100 |
Mechanical Turk administrative fees |
$220 |
|
Total |
$6,328 |
|
A.15 Explanation for Program Changes or Adjustments
This is a new collection of information.
Analyses will involve examining correlations and interactions among self-affirmation survey condition, risk perceptions, defensiveness against the message, and intentions to reduce alcohol consumption. We will disseminate our findings to relevant audiences –health psychologists/ public health researchers who capitalize on basic psychological science advances to develop efficacious health communications and interventions, and basic psychological scientists who study self-affirmation and affective experiences.
No statistical point estimates for the U.S. population will be produced, or published, based on this information collection
The project time schedule is outlined in Table A16-1. .
Table A16-1. Project Time Schedule
Activity |
Months after OMB Approval |
Post modules on mTurk (collect information) |
0 – 1 |
Information collection period |
1 - 2 |
Clean and analyze information |
2 - 3 |
Interpret and Summarize information |
3 - 4 |
Write report |
4 - 5 |
A.17 Reason(s) Display of OMB Expiration Date is Inappropriate
We are not requesting exemption from the display of the OMB expiration date.
A.18 Exceptions to Certification for Paperwork Reduction Act Submissions
This information collection will comply with the requirements in 5 CFR 1320.9.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Subject | Supporting Statement A |
| Author | Lopez, Maria (NIH/NICHD) [E] |
| File Modified | 0000-00-00 |
| File Created | 2021-01-24 |