E9-10608. Agency Information Collection Activities: Submission for OMB Review; Comment Request

Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on [phone].

Project: SAMHSA Fetal Alcohol Spectrum Disorders Center for Excellence Screening and Brief Intervention Evaluation—New

Since 2001, SAMHSA's Center for Substance Abuse Prevention has been operating the SAMHSA Fetal Alcohol Spectrum Disorders (FASD) Center for Excellence. The purpose of the FASD Center is to prevent FASD and improve the treatment of FASD. The FASD Center's activities include providing training, technical assistance, and subcontracts to increase the use of effective evidence-based interventions.

The FASD Center will be integrating Screening and Brief Intervention (SBI) for pregnant women through service delivery organizations and will be evaluating the results. Seven sites will implement the SBI program operated through WIC or Healthy/Health Start. Using the protocol developed by O'Connor and Whaley, each of the participating WIC and Healthy Start programs will be screening pregnant women to identify those who are currently drinking. The SBI focuses on 10- to 15-minute sessions of counseling by a counselor who will use a scripted manual to guide the intervention. Participants in the SBI will be assessed at each visit (to monitor alcohol use), referred for additional services to support their efforts to stop drinking, and will be provided with the 10-15 minute intervention. Clients will be followed up until their 36th week of pregnancy.

At baseline, a screening tool will be administered by the WIC or Healthy/Health Start counselor to assess pregnant women at the participating sites or health care delivery programs. Women will be assessed for risk using the T-ACE or TWEAK screening instruments which have been used successfully with pregnant women. Both quantity and frequency of drinking will be assessed. In addition, basic demographic data will be collected (age, race/ethnicity, education, and marital status) at baseline by participating sites but no personal identification information will be transmitted to SAMHSA.

On a monthly basis, as clients return for their WIC or Healthy/Health Start program counseling session, follow-up data will be collected by the WIC or Healthy Start counselor. At each monthly follow-up visit, the quantity and frequency of drinking will be assessed and the client's goals for drinking will be recorded. In addition, process level variables will be assessed to understand how the program is being implemented (e.g., whether SBI was delivered; what referrals were made; which referral services were received). At the 36th week of pregnancy, the client will be asked for permission to place her record from this program into her infant's medical record (upon delivery) and quantity and frequency of drinking will be assessed.

The data collection is designed to evaluate the implementation of the proposed Screening and Brief Intervention by measuring whether abstinence from alcohol is achieved. Furthermore, the project will include process measures to assess whether and how the intervention was provided.

Estimated Annualized Burden Hours

Screening tool/activity	Number of respondents	Number of responses per respondent	Average burden per response	Total burden hours per collection
Client Surveys: Assessment/Baseline Data Collection (Form A, B or C)	3,428	1	.25	857
Client Surveys: Monthly Follow-up (85% of baseline x 4 months maximum) (Form D, E and F)	2,914	4	.21	2,448
Assessment Data Collection at 36th week (85% of baseline) (Form D, G, and H)	2,914	1	.16	466
Total	3,428			3,771

Written comments and recommendations concerning the proposed information collection should be sent by June 8, 2009 to: SAMHSA Desk Officer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; due to potential delays in OMB's receipt and processing of mail sent through the U.S. Postal Service, respondents are encouraged to submit comments by fax to: 202-395-6974.

Dated: April 29, 2009.

Elaine Parry,

Director, Office of Program Services.