OMB_ss-b 9.24.13

SAMHSA Fetal Alcohol Spectrum Disorders (FASD) Center for

Excellence Knowledge-Base Expansion Program: Screening and

Brief Intervention Project (SBI) and Project CHOICES

THE SUPPORTING STATEMENT

B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

1. Respondent Universe and Sampling Methods

Ten sites from across the U.S. will be selected to participate in implementing the SBI program and/or Project CHOICES. All women who are seeking care through the selected sites will be screened. All of those who meet the eligibility criteria will be invited to participate. For pregnant women eligibility is determined by the following (reported within the past 30 days):

• Pregnancy status (must be pregnant for eligibility)

• Alcohol use (any)

• Past tolerance of alcohol use (determined by the TWEAK)

For non-pregnant women eligibility is determined by the following (reported within the past 30 days):

• Not pregnant or planning to conceive

• Age 18 to 44

• Sexually active with a male partner

• Ability to conceive

• Alcohol risk (monthly alcohol use = 31 or more drinks in 30 days) or binge drinking (4 or more drinks in 1 day) or outpatient alcohol treatment

• Ineffective use of contraception

As such, no sampling will be conducted; the complete universe of eligible participants will be screened and invited to participate.

2. Information Collection Procedures

Copies of the data collection forms are included in Attachments A-C. As described above, the sampling plan is purposive. Each potential participant will be informed of the purpose of the request for their participation, their right not to participate, and the degree to which the information they provide will be kept private. All data collection forms have an introduction script describing the above. Basic demographics (at screening) and client satisfaction (at end of program) will be collected from all women. Information collection procedures vary based on pregnancy status.

The following overview describes the typical eligibility and timeline for pregnant women:

1. Brief interventions (immediately after eligibility is determined and after any follow-up assessment that reveals alcohol use)

2. Process Information (immediately after each brief intervention conducted)

3. Process assessment #1 (30 days after eligibility for all women)

4. Process assessments #2, #3, etc. (30 days after each follow-up assessment if active use is reported; OR on a trimester basis for women who are not reporting active use)

5. End of program assessment (final monthly or trimester assessment prior to delivery)

The following overview describes the typical eligibility and timeline for non-pregnant women:

1. Intervention session #1 (immediately or shortly after eligibility is determined)

2. Contraceptive visit

3. Intervention session #2 (typically no more than 30 days following intervention session #1)

4. End of program assessment (following completion of Intervention session #2 and the contraceptive visit)

5. Follow-up assessment (3-months after end of program)

6. Follow-up assessment (6-months after end of program)

Knowledge-Base Expansion Assessment Form (Attachment A).

This is an assessment form with a sequence of questions that includes appropriate skip patterns based on pregnancy status. A common assessment form allows determination of eligibility at baseline, and assessment of outcomes at periodic intervals as defined by the program model, end of program, and follow-up. As a result, programs may collect data from women in either status using one assessment form to collect data for both the SBI and Project CHOICES programs.

SBI Process Information Form (Attachment B)

This form is used during the process of the program delivery and is collected after each SBI session is conducted. The client’s goals for drinking and duration of the session will be recorded.

Client Satisfaction Form (Attachment C)

This data collection form is administered at the end of the program to measure satisfaction of the women with the program.

3. Methods to Maximize Response Rates

Strategies to help sites maximize their response rates and minimize burden on respondents relies upon establishing rapport with clients from the start of the first session and includes more specific strategies such as:

1. Leaving a reminder voicemail or sending a reminder email to clients a few days before their upcoming appointment, to reduce the chance of a missed appointment.

2. At screening, requesting the name, phone number, and email address of both a relative and close friend of the client; obtaining the client’s permission to contact the friend and relative for help locating the client as needed for follow-up.

3. Using publicly available services to track down the client’s current address or phone number. For example, calling information (411) or using various internet sites (such as www.zabasearch.com).

4. The use of motivational interviewing is expected to increase engagement of the women.

4. Tests of Procedures

All data collection forms previously approved by OMB (0930-0302 and 0930-0303) were utilized as intended during the implementation phase from 2009-2012. Feedback from the sites administering the data collection forms during this implementation phase has been incorporated into the revised forms attached to this statement. The new data collection forms are an adaptation of the previous data collection forms to improve implementation, reduce burden, and increase engagement and retention, thus improving the overall ability to collect and report data.

5. Statistical Consultants

Data collection will be conducted at the ten sites that are integrating SBI and/or Project CHOICES. The task lead for the FASD SBI and Project CHOICES data collection is Lauren Shrader, who will oversee the data collection across the sites. Data analysis will be performed by the contractor, Northrop Grumman Corporation under the supervision of the Project Director, Jill Hensley. Previously, Lauren Shrader conducted the data analysis for the previously administered SBI (OMB#0930-0302) and Project CHOICES (OMB#0930-0303) programs. In addition, all sites will have data collection oversight at the local site level.

Contractor: Phone

Lauren Shrader Northrop Grumman Corporation 301-527-6523

Jill Hensley Northrop Grumman Corporation 301-527-6564

SAMHSA Project Officer:

Jon Dunbar-Cooper, M.A., C.P.P.

Public Health Analyst

SAMHSA/CSAP

Division of Systems Development

1 Choke Cherry Road

Fourth Floor - Room - 4-1020

Rockville, MD 20857

Work: (240) 276-2573

Fax:( 240) 276-2410

jon.dunbar@samhsa.hhs.gov

List of Attachments

A. Knowledge-Base Expansion Assessment Form

B. SBI – Process Information

C. Client Satisfaction

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