2010-24847. 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].

Proposed Project: Evaluation of Pregnant and Postpartum Women (PPW) Program

The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT), is funding 11 fiscal year (FY) 2009 Services Grants for the Residential Treatment for Pregnant and Postpartum Women (PPW) Program. The purpose of the PPW Program is to provide cost-effective, comprehensive, residential treatment services for pregnant and postpartum women who suffer from alcohol and other drug use problems, and for their infants and children impacted by the perinatal and environmental effects of maternal substance use and abuse.

Section 508 [290bb-1] of the Public Health Service Act mandates the evaluation and dissemination of findings of residential treatment programs for pregnant and postpartum women. This cross-site accountability assessment will assess project activities implemented for these services.

CSAT is requesting approval for a total of 8,404 burden hours for this new data collection. CSAT is requesting approval for a total of 23 instruments. Of these 23 instruments, 18 instruments are client-level tools and 5 instruments are process-level tools. To examine the effectiveness and impact of the PPW program, the current design includes both client-level outcomes and process evaluation components. The purpose of the outcome evaluation component is to examine the extent to which grantees accomplish the five core goals specified by the PPW program request for applications (RFA). These goals include:

• Decrease the use and/or abuse of prescription drugs, alcohol, tobacco, illicit and other harmful drugs (e.g., inhalants) among pregnant and postpartum women;
• Increase safe and healthy pregnancies; improve birth outcomes; and reduce related effects of maternal drug abuse on infants and children;
• Improve the mental and physical health of the women and children;
• Improve family functioning, economic stability, and quality of life; and
• Decrease involvement in and exposure to crime, violence, sexual and physical abuse, and child abuse and neglect.

In order to help interpret client-level outcomes, the process evaluation will explore what grantees are actually doing, how well they are doing it, any challenges encountered, and strategies grantees used to address them.

Data collection instruments will be used to collect outcome and process data for this cross-site accountability evaluation, program and treatment planning, and local evaluations. For clients, data will be collected from women at four time points (intake, 6-months post-intake, discharge, and 6-months post-discharge), consistent with the GPRA data collection schedule. The schedule for collecting child data is similar to the mothers, with the addition of a 3-month post-intake time point. The following interview instruments will be used for women, fathers/mother's partner, and children:

Women Focused Tools

• BASIS-24® (psychological symptomology).
• Child Abuse Potential Inventory (overall risk for child physical abuse).
• Ferrans and Powers Quality of Life Index (quality of life measure).
• Family Support Scale (helpfulness of sources of support to parents raising a young child).
• Women's Discharge Tool (services received, length of stay, treatment goals achieved).
• Staff Completed Women's Items (pregnancy status, problems and outcomes).
• Items Administered to Women (children residing with mother in treatment, tobacco use, physical abuse and sexual abuse in the past year).

Father and Partner Focused Tools

• Ferrans and Powers Quality of Life Index (quality of life measure).

Child Focused Tools

• Brief Infant Toddler Social and Emotional Assessment (children 12-35 months; social and emotional assessment).
• Child Data Collection Tool (all children; descriptive biopsychosocial measure).
• Children's Discharge Tool (all children; services received, length of stay, treatment goals achieved, whether child lived in the facility).
• CRAFFT (children 11-17; adolescent substance use screen).
• Newborn's Medical Record Audit (childen birth-3 months; birth outcomes).
• Parenting Relationship Questionnaire (children 2-17 years; parent's relationship with child).
• Parenting Stress Index (children 1 month—12 years; parenting stress).
• Social Skills Improvement System (children 3-17 years; social skills).
• Trauma Symptom Checklist for Young Children (3-12 years; trauma symptoms).
• Staff Completed Child Items (children 0-17; prematurity, child's recent primary residence, whether child will reside in treatment with mother).
• Staff Completed Newborn Items (children 0-3 months; prematurity, length of stay in hospital, neonatal intensive care unit (NICU), and treatment for neononatal abstinence syndrome).

Note that all child focused tools are records reviews or administered as maternal interviews with the exception of CRAFFT, which is administered to the children directly.

Process Evaluation Tools

• Biannual Project Director Telephone Interview (interview with grantee project directors to clarify information reported in their biannual progress reports);
• Site Visit Protocol—Client Focus Group (focus groups with clients to gather information about their experience in the program);
• Site Visit Protocol—Clinical Director(s)/Supervisor(s) (interviews with both the director of clinical services for women and the director of clinical services for children to gather more specific information about clinical services);
• Site Visit Protocol—Counselor(s) (interviews with counselors to gather information related to daily treatment operations and their experience in providing services); and
• Site Visit Protocol—Program Director (interview with grantee program directors to gather information about overall PPW programmatic issues).

All data will be collected using a combination of observation, records review, questionnaires, and personal interviews. CSAT will use this data for accountability reporting, and program monitoring to inform public policy, research, and programming as they relate to the provision of women's services. Data produced by this study will provide direction to the type of technical assistance that will be required by service providers of women's programming. In addition, the data will be used by individual grantees to support progress report efforts.

The total annualized burden to respondents for all components of the PPW program is estimated to be 8,404 hours. Table A-1 presents a detailed breakdown of the annual burden for all data collection instruments for all respondents (i.e., mother, child, project staff, partner/father (family members), medical staff, project director, clinical director, counselor, program director). The number of respondents for all child-focused tools is weighted, based on the percentage of children within the appropriate age bracket in the prior PPW evaluation. With the exception of the CRAFFT, all child-focused tools are completed for the child by the mother or project staff. The burden estimates, also summarized in Table A-2, are based on the reported experience of the 2006 cohort, proprietary instrument developer estimates and experience, pre-testing of the additional items completed by staff and administered to women, and pre-testing of process evaluation measures. There are no direct costs to respondents other than their time to participate.

Table A-1—Detailed Annual Burden for All Interviews & Surveys

Interviews and surveys	Respondent	Number of respondents 1	Responses per respondent	Total responses	Burden per resp. (hrs.)	Total burden (hrs.)
Child Focused Interviews:
CRAFFT (11-17 yrs) 2	Child	70	5	350	0.08	28
Brief Infant Toddler Social and Emotional Assessment (12-35 mos) 3	Mother	141	5	705	0.17	120
Child Data Collection Tool (0-17 yrs) 4	Mother	440	2	880	0.75	660
Parenting Relationship Questionnaire (2-17 yrs) 5	Mother	387	5	1,935	0.25	484
Parenting Stress Index (1 month-12 yrs) 6	Mother	418	10	4,180	0.5	2,090
Social Skills Improvement System (3-17 yrs) 7	Mother	326	5	1,630	0.42	685
Trauma Symptom Checklist for Young Children (3-12 yrs) 8	Mother	290	5	1,450	0.33	479
Women Focused Interviews:
BASIS-24®	Mother	440	4	1,760	0.25	440
Child Abuse Potential Inventory	Mother	440	4	1,760	0.33	581
Family Support Scale	Mother	440	4	1,760	0.17	299
Ferrans and Powers Quality of Life Index (Women)	Mother	440	4	1,760	0.17	299
Items Administered to Women	Mother	440	4	1,760	0.17	299
Partners/Fathers Interview:
Ferrans and Powers Quality of Life Index (Partners)	Partner/Father	110	2	220	0.17	37
Staff Completed Items/Record Reviews at 11 Facilities:
Children's Discharge Tool (0-17 yrs) 9	Project Staff	11	80	880	0.58	510
Women's Discharge Tool	Project Staff	11	40	440	0.58	255
Newborn's Medical Record Audit (0-3 mos) 10	Medical Staff	11	25	275	0.08	22
Staff Completed Newborn Items	Medical Staff	11	25	275	0.25	69
Staff Completed Child Items (0-17 yrs) 11	Project Staff	11	400	4,400	0.08	352
Staff Completed Women's Items 12	Project Staff	11	160	1,760	0.17	299
Process Evaluation:
Biannual Project Director Telephone Interview	Project Director	11	2	22	1	22
Site Visit Protocol—Client Focus Group 13	Mother	176	1	176	1.5	264
Site Visit Protocol—Clinical Director/Supervisor	Clinical Director/Supervisor	22	1	22	2	44
Site Visit Protocol—Counselor(s)	Counselor	33	1	33	1	33
Site Visit Protocol—Program Director	Program Director	11	1	11	3	33
Total		4,701		28,444		8,404
1 Data will be collected from women at four time points (intake, 6-months post-intake, discharge, and 6-months post-discharge), consistent with the GPRA data collection schedule. Figures in this table are based on 40 mothers per site with 2 children and 0.25 father/partner per mother. The schedule for collecting child data is similar to the mother's with the addition of a 3-months post-intake time point with selected tools for a total of five time points. All child focused tools are completed by the mother or project staff, with the exception of CRAFFT. For fathers and partners, data will be collected at two points (intake and discharge).
2 Based on 8% of 880 minor children ages 11 to 17 at intake, 3 months, 6 months, discharge, and 6-months post-discharge.
3 Based on 16% of 880 minor children ages 12-35 months at intake, 3 months, 6 months, discharge, and 6-months post-discharge.
4 Based on 440 mothers having 2 minor children at intake and/or delivery.
5 Based on 44% of 880 minor children ages 2 to 17 at intake, 3 months, 6 months, discharge, and 6-months post-discharge.
6 Based on 95% of 880 minor children ages 1 month to 12 years (n = 836). For simplicity, this calculation assumes that 95% of mothers have two children in this age group and complete the tool for each child at intake, 3 months, 6 months, discharge, and 6-months post-discharge.
7 Based on 37% of 880 minor children ages 3 to 17 at intake, 3 months, 6 months, discharge, and 6-months post-discharge.
8 Based on 33% of 880 minor children ages 3 to 12 at intake, 3 months, 6 months, discharge, and 6-months post-discharge.
9 Based on 1 staff member at each of the 11 programs completing the tool for 80 children at discharge.
10 Based on 31% of 880 minor children ages 0-3 months at intake or delivery.
11 Based on 80 minor children per site ages 0 to 17 at intake, 3 months, 6 months, discharge, and 6-months post-discharge.
12 Based on 1 staff member at each of the 11 programs completing items for 40 women at intake, 6 months, discharge, and 6-months post-discharge.
13 Based on 2 focus groups with 8 mothers at each site.

Table A-2—Summary Total Annual Respondent Burden

Respondent	Number of respondents	Responses per respondent	Total responses	Hours per response	Total hour burden
Mothers	440		19,756		6,700
Partners/Fathers	110		220		37
Children (11-17 yrs)	70		350		28
Medical Staff	11		550		91
Project Staff	11		7,480		1,416
Project Director	11		22		22
Clinical Director/Supervisor	22		22		44
Counselor	33		33		33
Program Director	11		11		33
Total	719		28,444		8,404

Note:

Total number of respondents represents the number of each type of respondent that will be completing at least one tool across eleven sites over one year of data collection. The number of respondents (719) reported on this table differs from Table A-1 total number of respondents (4,701) which reflects completion of all tools across eleven sites over one year of data collection.

Written comments and recommendations concerning the proposed information collection should be sent by November 3, 2010 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: 202-395-7285.

Dated: September 28, 2010.

Elaine Parry,

Director, Office of Management, Technology and Operations.