Supporting Statement Part B

Attachment Number	Document Description
1	Public Health Service Act Legislation
2	Federal Register Notice
3	Middle School Student Focus Group Guide
4	Consultants on the Information Collection
5	Documentation of IRB Approval
6	Parental Consent Form
7	Student Verbal Assent Language
8	Description of Changes from Previously Approved Data Collection
9	Data Collectors’ Non-Disclosure Agreement

Section B: Collections of Information Employing Statistical Methods

B.1 Respondent Universe and Sampling Methods

The respondent universe for the student focus groups consists of FWISD middle school students who are enrolled in health education classes during the 2016-2017 school year (n= approximately 6,500). Two middle schools with after-school programs will be selected for participation based on (1) having large numbers of students for sufficient gathering of the sample, (2) recommendation from FWISD district staff, and (3) willingness of the school administration to allow students to be recruited and participate during after-school activities. Across these schools, more than 500 students are estimated to be enrolled in spring semester health education classes. In each participating school, students who are enrolled in health education will receive a letter to take to parents that provides information on the study and a place for parents to provide active consent for students to participate (see Attachment 6). Focus group participation will be open to the subset of students who are both enrolled in health education classes and attend the after-school programs at one of the two participating middle schools.

Consent forms will be distributed and collected for 7 days. After 7 days, a second round of consent forms (copies of the original form) will be redistributed to students who had not returned the consent form originally. From the pool of returned parental consent forms, the study team will randomly select 12 male students and 12 female students from each of the two schools to participate in the focus groups. A total of 48 students will be scheduled to participate in the focus groups.

Information Collection	Respondent Type	Maximum number of Respondents
Student focus groups	Middle school male students	24
Student focus groups	Middle school female students	24

B.2 Procedures for the Collection of Information

Student focus groups (n=4) will be held in late spring 2017 (pending OMB approval). Each focus group will include up to 12 students. The focus groups will be stratified by gender (2 focus groups will include female students in middle school and 2 focus groups will include male students in middle school).

Each focus group will be moderated by one study team member (a CDC contractor) and will include one additional study team member (a CDC contractor) as the note-taker. The moderator will use a semi-structured focus group guide (see Attachment 3) that lists key questions and allows the moderator to probe for additional insight.

Focus groups will take place during non-instructional (after-school) hours to ensure participation does not interfere with students’ learning. The location of the focus groups will vary by individual school but will be in accordance with school administration recommendations and will be in a secure and private space comfortable for students. Focus groups will last no more than 90 minutes. All focus groups will be audio-recorded (with participant permission) to ensure an accurate account of what was discussed. Since the focus groups will take place after school hours, student transportation must be pre-arranged by the student’s parent/guardian. Focus groups will be scheduled in advance to allow parents time to plan accordingly.

Power Analysis

All students in 2 middle schools that are enrolled in health class during the spring 2017 academic semester and attend the after-school program are being invited to participate. It was not feasible to conduct focus groups in all schools (students would need transportation to other locations for the focus group), so for logistical purposes and to improve our ability to gain buy-in from school administrators, we limited the student data collection to a small number of schools. The schools will be selected because they have established after-school programs and enroll large numbers of students with diverse characteristics (race, ethnicity, income, etc). From the pool of students who return parental consent forms, groups of students (stratified by gender) will be selected for participation at random. Our goal in both of these information collections is to ensure input that is as broadly representative as possible and reduce potential for bias, but for this qualitative data collection, we do not expect results to be generalizable to all health education students.

B.3 Methods to Maximize Response Rates and Deal with No Response

All health education students who attend the after school program in 2 schools will be given information about the study and invited to return parental consent forms. Among the students who return consent forms, students will be grouped into 2 stratifications: middle school male students and middle school female students. Within each of these groups, 24 students will be invited to participate in the focus groups. Students will be contacted to schedule the focus group and gain confirmation of attendance. For each student who does not confirm availability, an alternate student from that same stratified group will be selected at random for the invitation. This process will begin weeks in advance of the focus group so that all invited slots can be filled with confirmed participants. However, the study team is aware that even confirmed participants may not show up on the day of the focus group. For this reason, 12 students are being invited to each group, with the expectation that groups could be run successfully (and meaningfully) with as few as 8 students per group.

B.4 Tests of Procedures or Methods to be Undertaken

The focus group guide was developed with the extensive input of expert consultants both internal and external to CDC and the CDC’s contractor. Guides were constructed around key concepts found in the literature related to sexual health education, and were tailored for the context of FWISD with assistance from FWISD district-level staff. Focus group guides were reviewed for content, clarity, and appropriateness by two FWISD district employees and the full study team (staff from CDC and its contractor) which include several former teachers; revisions were made to refine the guides based on the collective input. CDC’s contractor then pilot tested the guides with 4 youth between the ages of 13-17 to ensure questions were clear and easily understood by the target ages for the focus groups. The feedback from the piloting process was used to further refine the instruments and prepare for moderator training.

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Individuals consulted on statistical aspects and study design:

Catherine Lesesne, Ph.D.

ICF International

3 Corporate Square, Suite 370

Atlanta, GA 30329

Catherine.Lesesne@icfi.com

404-321-3211 (phone)

404-321-3688 (fax)

Colleen Murray, DrPH

Manager, ICF International

3 Corporate Square, Suite 370

Atlanta, GA 30329

Colleen.Murray@icfi.com

404-321-3211 (phone)

404-321-3688 (fax)

The individuals overseeing data collection and directing data analysis are:

Catherine Lesesne, Ph.D.

ICF International

3 Corporate Square, Suite 370

Atlanta, GA 30329

Catherine.Lesesne@icfi.com

404-321-3211 (phone)

404-321-3688 (fax)

Colleen Murray, DrPH

Manager, ICF International

3 Corporate Square, Suite 370

Atlanta, GA 30329

Colleen.Murray@icfi.com

404-321-3211 (phone)

404-321-3688 (fax)

Catherine Rasberry, PhD

CDC/OID/NCHHSTP, Health Scientist (Contracting Officer’s Representative providing oversight)

(404) 718-8170 (phone)

fhh6@cdc.gov

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