Terms of Clearance Memo

Date: August 22, 2007

To: OMB Desk Officer

From: SAMHSA Clearance Officer

Subject: Terms of Clearance

This memo addresses the Terms of Clearance memorandum dated September 20, 2005 for the current OMB approval of the Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment’s Cross-Site Accountability Assessment of the Residential Treatment for Pregnant and Postpartum Women and Their Minor Children Program (PPW) (OMB No. 0930–0269). This approval expires on September 30, 2007.

The September 20, 2005 Notice of Action from OMB stated that the PPW (OMB No. 0930–0269) is:

“Approved consistent with revisions and clarifications submitted by SAMHSA to OMB 09/13/05. OMB approves the requested collection of information for a period of two years, prior to the next submission of the collection of information to OMB for review SAMHSA shall consult with partners concerning improving measurements of program effectiveness. Specifically, OMB encourages SAMHSA to include control groups for future assessment purposes where possible.”

It is well known that the use of drugs, alcohol, and tobacco has a negative impact on maternal health and pregnancy outcomes. Outcome data are used to measure the success of clinical treatment and recovery support services. The results are used to assess the need to continue CSAT’s targeted PPW programs, to design programs, to coordinate systems of care, and to provide assistance that ensures such programs can contribute appropriately to treatment and prevention of substance abuse among pregnant women and the prevention of health and educational problems among the offspring of these women.

This Assessment meets the requirements of the SAMHSA accountability performance domains or National Outcome Measures (NOMS) and CSAT has established core standardized Government Performance and Results Act (GPRA) (OMB No. 0930-0208) client/participant outcome treatment measures for all grant programs. These outcome treatment measures are collected for the PPW program and are linked to each mother in the Cross-site Assessment.

CSAT is interested in determining the PPW programs and client level performance as a part of the accountability assessment in specific areas including abstinence from drug and alcohol use,

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employment and education, criminal or juvenile justice involvement, family and living conditions, social support, services access and capacity, and retention in clinical treatment and/or recovery support services.

The primary purpose of the performance monitoring plan is to assess and monitor project performance in an effort to document accountability and improve program quality. This contrasts with research and evaluation where the emphasis is on long-term effectiveness and outcomes. Emphasis is on short-term program and client level outcomes and performance. Therefore, CSAT did not include or focus on long-term effectiveness outcomes such as drug use at the one to five year post-discharge period. While it is important to examine questions like the proportion of clients and children who start using drugs again after the program, CSAT is operating with several constraints including funding, time, and the intent not to conduct full-scale research or evaluation.

All data CSAT is planning to collect are strongly related to the purpose and goals. Specifically, the maternal outcomes of interest include the following: 1) Service utilization rate; 2) Types of services received; 3) Costs of services; 4) Treatment effectiveness; 5) Indigenous resources; 6) Project sustainability; 7) Reduced Drug use; 8) Enhanced mental health and well-being; 9) Improved family functioning; 10) Life satisfaction; and, 11) Barriers to treatment. In addition, the infant and child health outcomes include the following: 1) Improved mental and physical health; 2) Reduction in related effects of maternal substance abuse (better nutrition, clothing; improved parental supervision; stronger capacity for childcare; continuity of parenting; parental recognition of problems; parental affection; physical abuse; sexual abuse; personal hygiene; threat of abuse; protection from abuse; less substance use); and, 3) Services to children in residential treatment.

There are several maternal and child health outcomes for which it is reasonable to see a measurable difference in the time period of the study. The maternal health outcomes include the following: 1) More effective management of chronic illnesses such as diabetes; 2) Increased levels of education and self-care through regular visits to health care providers and by health exams completed. The child health outcomes for which it is reasonable to see a significant difference include: 1) More effective management and chronic illnesses; 2) Safe detox experience for children in withdrawal at birth.

Data was collected for the first (2003) cohort for the final six months of their funding periods, which did not provide sufficient information for the Report to Congress. Hence, in September 2006, SAMHSA awarded a cohort of eight PPW grants for a period of three years. Feedback was provided during a focus group, meetings, conference calls, the training sessions, by e-mail, and by telephone. Based on that feedback, the following modifications were proposed: (1) to implement modifications to the instruments based on experiences gained during training on the cross-site process and instrument administration and data collection with the 2003 cohort; (2) to replace the 12-month post-intake data collection wave with a 6-month post-discharge data collection wave to ensure that post-discharge data is collected on all women (as some may still

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be in residential treatment at 12 months) and because it is important to collect post-discharge outcome data for all women ─ especially over a uniform interval (i.e., 6 months); (3) to increase the number of sites and participants involved in this Cross-site Assessment; and, (4) to increase the target population to ensure that the PPW program is more family-centered, as required in Congressional budget language for the PPW program for 2006..

Given the scope of the project and time schedule, the Cross-site Assessment should be able to adequately address the primary questions and goals. CSAT will not be able to assess program effectiveness because of the limitations of the project design (i.e., no controlled circumstances or randomization). However, CSAT believes that the information gained will still be valuable and useful information that will inform future work in this area.

If there are any questions or comments regarding this information, please contact Summer King on (240) 276-1243.