[Federal Register Volume 75, Number 191 (Monday, October 4, 2010)]
[Notices]
[Pages 61144-61147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24847]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


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 (240) 276-1243.

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:
    <bullet> Decrease the use and/or abuse of prescription drugs, 
alcohol, tobacco, illicit and other harmful drugs (e.g., inhalants) 
among pregnant and postpartum women;
    <bullet> Increase safe and healthy pregnancies; improve birth 
outcomes; and reduce related effects of maternal drug abuse on infants 
and children;
    <bullet> Improve the mental and physical health of the women and 
children;
    <bullet> Improve family functioning, economic stability, and 
quality of life; and
    <bullet> 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

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

[[Page 61145]]

treatment, tobacco use, physical abuse and sexual abuse in the past 
year).

Father and Partner Focused Tools

    <bullet> Ferrans and Powers Quality of Life Index (quality of life 
measure).

Child Focused Tools

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

    <bullet> Biannual Project Director Telephone Interview (interview 
with grantee project directors to clarify information reported in their 
biannual progress reports);
    <bullet> Site Visit Protocol--Client Focus Group (focus groups with 
clients to gather information about their experience in the program);
    <bullet> 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);
    <bullet> Site Visit Protocol--Counselor(s) (interviews with 
counselors to gather information related to daily treatment operations 
and their experience in providing services); and
    <bullet> 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
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                                                                             Number of
          Interviews and surveys                     Respondent             respondents    Responses per       Total        Burden per     Total burden
                                                                                \1\         respondent       responses     resp.  (hrs.)      (hrs.)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Child Focused Interviews:
    CRAFFT (11-17 yrs) \2\................  Child.......................              70               5             350            0.08              28
    Brief Infant Toddler Social and         Mother......................             141               5             705            0.17             120
     Emotional Assessment (12-35 mos) \3\.
    Child Data Collection Tool (0-17 yrs)   Mother......................             440               2             880            0.75             660
     \4\.
    Parenting Relationship Questionnaire    Mother......................             387               5           1,935            0.25             484
     (2-17 yrs) \5\.
    Parenting Stress Index (1 month-12      Mother......................             418              10           4,180             0.5           2,090
     yrs) \6\.
    Social Skills Improvement System (3-17  Mother......................             326               5           1,630            0.42             685
     yrs) \7\.
    Trauma Symptom Checklist for Young      Mother......................             290               5           1,450            0.33             479
     Children (3-12 yrs) \8\.
Women Focused Interviews:
    BASIS-24[reg].........................  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      Mother......................             440               4           1,760            0.17             299
     Index (Women).
    Items Administered to Women...........  Mother......................             440               4           1,760            0.17             299
Partners/Fathers Interview:

[[Page 61146]]

 
    Ferrans and Powers Quality of Life      Partner/Father..............             110               2             220            0.17              37
     Index (Partners).
Staff Completed Items/Record Reviews at 11
 Facilities:
    Children's Discharge Tool (0-17 yrs)    Project Staff...............              11              80             880            0.58             510
     \9\.
    Women's Discharge Tool................  Project Staff...............              11              40             440            0.58             255
    Newborn's Medical Record Audit (0-3     Medical Staff...............              11              25             275            0.08              22
     mos) \10\.
    Staff Completed Newborn Items.........  Medical Staff...............              11              25             275            0.25              69
    Staff Completed Child Items (0-17 yrs)  Project Staff...............              11             400           4,400            0.08             352
     \11\.
    Staff Completed Women's Items \12\....  Project Staff...............              11             160           1,760            0.17             299
Process Evaluation:
    Biannual Project Director Telephone     Project Director............              11               2              22               1              22
     Interview.
    Site Visit Protocol--Client Focus       Mother......................             176               1             176             1.5             264
     Group \13\.
    Site Visit Protocol--Clinical Director/ Clinical Director/Supervisor              22               1              22               2              44
     Supervisor.
    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
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\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
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                                     Number of     Responses per       Total         Hours per      Total hour
           Respondent               respondents     respondent       responses       response         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
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    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

[[Page 61147]]

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.
[FR Doc. 2010-24847 Filed 10-1-10; 8:45 am]
BILLING CODE 4162-20-P