National Survey on Drug Use and Health:
Lead Letter Focus Groups
A. JUSTIFICATION
The Substance Abuse and Mental Health Services Administration (SAMHSA) is requesting the Office of Management and Budget (OMB) approval to conduct up to nine online focus groups to obtain feedback on the overall appearance and specific elements of the current version versus an alternative version of the Lead Letter (included in Attachment A) for the National Survey on Drug Use and Health (NSDUH). These focus groups would require recruiting up to 54 adult participants (aged 18 or and older), in English and Spanish across the four Census Bureau regions and Puerto Rico This focus group package is submitted under the NSDUH Methodological Field Tests generic OMB clearance (OMB No. 0930-0290).
NSDUH is sponsored by SAMHSA’s Center for Behavioral Health Statistics and Quality (CBHSQ) and approved under OMB No. 0930-0110. The data collection is a national survey of the U.S. civilian, non-institutionalized population aged 12 and older. This survey is paramount to meeting a critical objective of SAMHSA’s mission—to maintain current data on the incidence and prevalence of substance use and mental health problems in the United States. NSDUH, under various names, has been conducted on a periodic basis from 1971 to 1988, and annually since 1990.
NSDUH is authorized by Section 505 of the Public Health Service Act (42 USC 290aa4 – Data Collection). Section 505 specifically authorizes annual data collection for monitoring the incidence and prevalence of illicit substance use and mental health problems, as well as the abuse of licit substances in the U.S. population.
With some minor changes over the years to allow for multimode data collection (in-person and web-based), the NSDUH has mailed a similar Lead Letter to sampled dwelling units at the start of each data collection quarter. The letter informs households about their selection to participate in an interview, the topics covered by the survey, and how to participate, among other details. Recently, the Behavioral Insights Team (BIT), a NSDUH subcontractor, developed an alternative version of the NSDUH Lead Letter (Letter B in Attachment A) for CBHSQ to consider implementing.
This study will involve conducting eight online focus groups (in English or Spanish) with adults across the four Census Bureau regions and one online Spanish language group with residents of Puerto Rico1. Therefore, a total of nine focus groups will be conducted. Six participants will be recruited for each group for an expected total of 54 adult participants (aged 18 or and older). The online focus groups will be conducted using Zoom videoconferencing software.
As mentioned above, the purpose of these online focus groups is to obtain feedback on the overall appearance and specific elements of the current version versus an alternative version of the NSDUH Lead Letter (included in Attachment A). Specifically, these online focus groups will determine whether any of the text or formatting of the alternative version of the Lead Letter (Letter B) is viewed more or less positively than the current version (Letter A). In addition, participant feedback will help determine whether further changes are needed to the Lead Letter text or format. Like all initial assessment of lead letters, the objective is to improve the clarity and readability of the letter for all members of the NSDUH target population. This objective includes making it as easy as possible for members of sample dwelling units to determine how they can participate.
Focus groups are ideal for this purpose, because they facilitate exploring people's knowledge and experiences related to being asked to participate in a survey. The focus group results will be used to examine not only what people think, but how they think and why they think as they do. SAMHSA expects to get feedback on topics including overall impressions, the layout, the graphics, and other features of the letters.
Whether recruited online or locally and conducted online or locally, focus groups do not have the capacity to, and are not intended to, provide representative data on how specific changes to the NSDUH lead letter could affect the composition of survey respondents. SAMHSA expects the focus groups could provide some indication on elements of the alternate letter that could lead to bias among survey respondents. Such indications could not be considered conclusive and SAMHSA will not treat them as conclusive.
SAMHSA does not have specific plans to introduce an alternate version of the NSDUH lead letter. If the alternate letter elicits positive feedback from focus group participants, SAMHSA would then decide which elements of the alternate letter should be incorporated into the current letter.
Information technology will be used in three primary situations: 1) participant recruitment, 2) participant screening and 3) the online focus groups.
Participant Recruitment: Most or all participants will be recruited via the Focus Group Recruitment Ad (Attachment B) that focuses on (1) language group and (2) region/location where the participants live. Amazon, Mechanical Turk (MTurk), Craigslist, and Facebook will be the online methods for recruitment. For recruiting mostly/only Spanish speakers for the Spanish focus groups, local organizations in cities with a large proportion of Hispanic/Latino people based on Census data will be contacted.
Participant Screening: All participants will be screened for eligibility using a short questionnaire administered via the web. This Online Eligibility Screener (Attachment C) will provide a simple way to confirm eligibility. The screener will be programmed using a web survey platform that uses secure (i.e., https) share links, is password protected, and is hosted inside a network that is FIPS-Moderate compliant. Response data will be collected and stored in SQL Server databases that reside inside a FIPS-Moderate security perimeter. Electronic screening data are accessible only within a FIPS-Moderate Virtual Desktop Infrastructure (VDI) environment.
During the screening, information will be collected on each respondent’s age, gender identity, race/ethnicity, education level, primary language, city and state of residence, and access to a desktop or laptop computer with the necessary software for audio and video capabilities on Zoom. Furthermore, contact information (first name, e-mail address, and telephone number) will also be collected from potential participants. To receive focus group information, participants will be required to have an email address that can receive attachments. The online eligibility screener concludes by thanking the potential participants for their time and informs them that a project team member will contact them if they are eligible for selection.
Project team members will then contact eligible individuals and provide them with several focus group dates/time options to confirm their availability. Once their availability is confirmed, participants will be reminded about the incentive they are eligible to receive upon completing the focus group. Their preferred incentive method (see Section A.9) and contact information for delivering the incentive will be asked and recorded. These participants will later receive a confirmation e-mail containing the date and time for their assigned focus group, the group meeting information, and the Focus Group Informed Consent Form (Attachment D) to review.
Online Focus Group: As mentioned in Section A.1, all online focus groups will be conducted virtually via Zoom. The sessions will be audio and video recorded so the research team can reference the recordings when compiling notes for the results memo. Each session will have a focus group moderator and notetaker. Moderators will be survey methodologists with experience moderating focus groups in either English or Spanish. To conduct each focus group, the moderator will use the Focus Group Moderator’s Guide (Attachment E).
Before beginning each focus group, the moderator will introduce themselves and complete the informed consent process. The moderator will review the Focus Group Informed Consent Form (Attachment D), answer any questions, and ask each participant to confirm their willingness to participate and be recorded. For logistical purposes, participants must consent to be audio and video recorded in order to be included in the study. If anyone decides to withdraw from the study, the moderator will thank them for their interest and the notetaker will politely remove them from the session. After the informed consent section, the moderator will begin the introduction section where general rules/etiquettes are reviewed, and participants are asked to introduce themselves to the group by first name only.
Next, the moderator will begin the recording and proceed with subsequent sections of the Focus Group Moderator’s Guide (Attachment E).
The recordings will be destroyed after the study results memo has been completed and approved by CBHSQ.
The moderator, notetaker, and other project observers may take notes electronically on their laptops, which are also secured with Check Point Endpoint disk encryption software. Thus, the data on the laptops will be encrypted. Any hard-copy notes that are transcribed electronically will not include any personally identifiable information (PII). All names and any other PII will be redacted before transcribing.
CBHSQ is in contact with all major federal health survey managers and is aware of no other efforts to assess how potential respondents may react to changes made to the NSDUH Lead Letter. To date, no duplication of effort has been identified.
This survey does not involve small businesses or other such entities.
The data collection is scheduled for mid-September through mid-October 2023 with the results memo being completed by mid-November 2023. This project is a one-time collection and will not be repeated.
This information collection fully complies with 5 CFR 1320.5(d)(2).
The NSDUH contractor, RTI International, partnered with BIT to develop the alternative version of the Lead Letter for these focus groups. BIT is a consulting firm that uses behavioral science and evidence-based approaches to improve perceptions of government-sponsored data collection efforts and maximize respondent participation.
There are no unresolved issues resulting from this consultation.
Online focus group participants will be given a $75 gift card upon completion of their session. Participants will have two options—either an electronic gift card sent to their email address, or a physical gift card mailed to their physical address.
The focus groups will not exceed 60 minutes. This incentive amount will be sufficient to compensate for the participants’ time and is consistent with the amount requested for other studies of this length.
The incentive for the focus group is mentioned in the following materials: Focus Group Recruitment Ad (Attachment B), Focus Group Informed Consent Form (Attachment D), Focus Group Moderator’s Guide (Attachment E), and the Focus Group Incentive Correspondence (Attachment F).
Concern for the confidentiality and protection of respondents’ rights has always played a central part in the implementation of NSDUH and will continue to be given the utmost emphasis. This is also the case for the planned NSDUH Lead Letter online focus groups.
The Contractor’s Institutional Review Board (IRB) was granted a Federalwide Assurance (Attachment G) by the Office for Human Research Protections (OHRP) and HHS in compliance with the requirements for the protection of human subjects (45 CFR 46).
The online focus groups will incorporate several procedures to ensure that participants’ rights will be protected and to reduce the risk of distress due to disclosure of responses. The Focus Group Recruitment Ad (Attachment B) and the Focus Group Informed Consent Form (Attachment D) both indicate that the participants’ answers will be kept private and confidential; information given by the participants will not be shared with any persons aside from the project staff and the other focus group participants in the session; their last name will never be connected with the answers they provide; and that their answers will be kept confidential. Participants are informed that their responses are voluntary and are assured that there will be no penalties if they decide not to respond, either to the information collection as a whole or to any particular question. The only people who will have access to any of the responses given by the participants are researchers at RTI and CBHSQ. All of these people will have completed the Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA) training and signed the NSDUH Confidentiality Pledge (Attachment H) prior to performing any work on this study.
The contact information collected during recruitment and screening will be used to remind participants about their upcoming session and to recruit additional participants placed on a wait list if any originally recruited participant is no longer available or misses their session. Up to three eligible participants will be placed on the wait list for each focus group.
During the recruitment process, potential participants will be told that the audio and video interactions between them and the moderator during the focus group will be recorded to ensure all the information from them on their reaction to the Lead Letters is captured. Participants will be told that the recordings will be heard and viewed only by members of the research team. Additional information on the recordings is provided in the Focus Group Informed Consent Form (Attachment D). This document informs participants that the recordings will be destroyed once they have been used in completing the study results memo.
All communication regarding a participant will only include the first name of the participant and the date and time of their focus group. Any other materials connecting the first name of the participant with their e-mail address or telephone number will be locked in a cabinet (if in hardcopy form) or password protected (if in electronic form). This password will be set to expire within four weeks after the last focus group is completed and both the electronic files and hard copies will be destroyed at that time.
Before beginning each focus group, the moderator will review the Focus Group Informed Consent Form (Attachment D) with the group and collect each participant’s verbal consent. As noted in A.3, a copy of the consent form will be provided to participants via their confirmation e-mail. Only those participants who give verbal consent will participate in the focus group.
Although some personal information will be collected during the recruitment process, data will not be retrieved by personal identifiers, and thus the Privacy Act does not apply to these activities. More specifically, during the recruitment process, age, gender identity, race/ethnicity, education level, primary language, city and state of residence, and access to a desktop or laptop computer with audio and video capabilities will be collected. The e-mail addresses and telephone numbers collected will be used to either remind the participants about their upcoming focus group or to recruit additional participants who were placed on a wait list if any originally recruited participant is no longer available or misses their session. No links to individuals of any kind will be preserved in the focus group results memo.
Some questions in the Online Eligibility Screener (Attachment C) may be of a sensitive nature (e.g., gender identity). To reduce risks, participants will complete the screening online and be told to make sure they are completing the questions in a private location.
No sensitive data will be collected in the focus groups. All questions and probes presented in the focus groups will refer only to the NSDUH Lead Letters and participants’ opinions about the materials. The Focus Group Moderator’s Guide (Attachment E) does not include questions or probes that encourage participants to divulge any personal information about themselves.
Up to 54 participants will take part in the online focus groups for this study. Based on prior experience, it is expected that approximately 450 screenings (50 screenings for 9 sessions) with potential participants will be needed to obtain the 54 study participants.
Administration of the Online Eligibility Screener (Attachment C) during the recruitment process will take an average of five minutes per participant. It is estimated that the average amount of time required to conduct each focus group will be approximately 60 minutes.
The respondent burden for this study is shown in Table 1. The hourly wage of $20.66 was calculated based on weighted data from the 2022 NSDUH respondents’ personal annual income.
Table 1. Estimated Burden for Focus Groups
Activity |
Number of Respondents |
Responses per Respondent |
Average Burden per Response (Hours) |
Total Burden (Hours) |
Hourly Wage Rate |
Total Hour Cost |
Screening |
450 |
1 |
0.083 |
37.35 |
$20.66 |
$771.65 |
Focus Group |
54 |
1 |
1.000 |
54.00 |
$20.66 |
$1,115.64 |
TOTAL |
504 |
– |
– |
92.00 (rounded) |
– |
$1,887.29 |
There are no capital, startup, operational, or maintenance costs to respondents.
Total costs associated with the focus groups are estimated to be $88,426 over a 2-month period. This cost includes incentives of $75 for 54 participants. Of the total costs, $43,426 are for contract costs (e.g., study design, recruiting/screening, conducting focus groups, analyzing, and developing a report for CBHSQ), and approximately $45,000 represents CBHSQ costs to manage the task.
Currently there are 788 total burden hours in the OMB inventory. For the Lead Letter Focus Groups, CBHSQ is requesting 92 burden hours, leaving a balance of 696 burden hours.
The results from the online focus groups will be used to gauge the impact of edits to the existing Lead Letter for future waves of the NSDUH survey. The sample size and design do not allow for statistical inference to be conducted; therefore, the analyses will be qualitative. As a result, the analyses will be based on observations that contribute to key themes. Moderators and notetakers will provide their notes from conducting the online focus groups and their assessments of respondents’ reactions to the materials.
When the study has been completed, the CBHSQ and RTI liaisons may discuss opportunities for presenting results of the study to the external research community at a professional conference and/or via external publication.
The time schedule for the Lead Letter Focus Groups is indicated in Table 2.
Table 2. Schedule for Pretest
Subtask |
Date |
Begin focus group recruitment |
9/13/2023 |
Complete all focus groups |
10/18/2023 |
CBHSQ receives draft memo on focus group results |
11/1/2023 |
CBHSQ provides feedback on draft memo on focus group results |
11/8/2023 |
CBHSQ receives final memo on focus group results |
11/22/2023 |
The OMB expiration date will be displayed at the bottom of the Focus Group Informed Consent Form (Attachment D).
The certifications are included in this submission and fully comply with 5 CFR 1320.9.
Attachment A Current and Alternative Lead Letter
Attachment B Focus Group Recruitment Ad
Attachment C Online Eligibility Screener
Attachment D Focus Group Informed Consent Form
Attachment E Focus Group Moderator’s Guide
Attachment F Focus Group Incentive Correspondence
Attachment G Federalwide Assurance
Attachment H NSDUH Confidentiality Pledge
1 SAMHSA is exploring expansion of NSDUH data collection into Puerto Rico starting in 2024.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | 2003 National Survey on Drug Use and Health |
| Author | lky |
| File Modified | 0000-00-00 |
| File Created | 2023-10-02 |