02-11559. Multi-Level Parent Training Effectiveness Trial; Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2002 funds for a cooperative agreement or grant program for a Multi-level Parent Training Effectiveness Trial to test the implementation of a culturally sensitive and responsive parenting program to prevent child maltreatment, specifically child physical abuse and neglect. This program addresses the “Healthy People 2010” focus area of injury and violence prevention.

The purpose of this program is to examine the effectiveness of a multi-level parent training program for families with children ages six and younger. The research trial will test the effectiveness of a multi-level intervention program that promotes positive parenting strategies in order to prevent child maltreatment. As an effectiveness trial, the program is required to examine the broad implementation of interventions with demonstrated efficacy rather than to test the efficacy of new interventions. The program must examine effects both with the individuals directly involved in the interventions, and the larger community in which the intervention program is implemented.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Injury Prevention and Control: Reduce the risk of child maltreatment.

Methodology

This cooperative agreement seeks methodologically rigorous proposals rigorous designs and direct measures of outcomes with extended follow up. Rigorous designs could include experimental designs in which families, communities, or other units are randomly assigned to the intervention group (with level to be determined by assessment) and control or comparison groups, or strong quasi-experimental designs in which families, communities, or other units are matched appropriately. Minimally, applicants are required to justify their use of the research design chosen, and should discuss the merits of the design with respect to attributing changes in behavior to the interventions.

Minimally, applicants are required to conduct measurement pre and post-intervention, and one year after the intervention for intervention and control/comparison group. Repeated measurement should be considered. Measures may require sampling both the individuals directly involved in the intervention, and a larger community sample in order to examine community-wide effects of the intervention program. For example, assessing a community-wide media campaign would require community sampling to measures exposure and impact.

Applicants must include measures of both the positive parenting strategies the interventions seek to change and measures of child maltreatment. Direct measures of parenting strategies (i.e., behavioral observations) utilizing methods such as time sampling or interval recording are required, as are child maltreatment incident reports to measure program effects on child maltreatment. Standardized, validated indirect measures of parenting and child outcomes are also required (e.g., ECBI, CBCL, PPI, PSI), along with proxy measures for child maltreatment (e.g., CAPI). Finally, measures of social validity (Wolf, 1978) should be used to assess participant reaction to the goals, process, and outcomes of the interventions. Additional measures may of course be included at the applicant's discretion.

Applicants are required to clearly state plans to ensure intervention fidelity. Specifically, applicants must describe plans for ensuring that the curriculum is implemented as it has been designed. Applicants should also describe plans to assess whether staff have been successfully trained (i.e., Can staff demonstrate intervention delivery?) and whether parents have been successfully trained (i.e., Can parents demonstrate the parenting skills taught?). Intervention programs that have certification for those trained to deliver the intervention are preferred.

B. Eligible Applicants

Maximum Competition

Applications may be submitted by public and private nonprofit organizations and by governments and their agencies; that is, universities, colleges, technical schools, research institutions, hospitals, other public and private nonprofit organizations, community-based organizations, faith-based organizations, State and local governments or their bona fide agents, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau, federally recognized Indian Tribal Governments, Indian Tribes, or Indian Tribal Organizations.

Note:

Title 2 of the United States Code section 1611 states that an organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant or loan.

C. Availability of Funds

Approximately $1.5 million is available in FY 2002 to fund one award. It is expected that the award will begin on or about September 30, 2002, and will be made for a 12 month budget period within a project period of up to five years. Funding estimates may change.

Continuation awards within an approved project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds.

D. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities under 1. Recipient Activities, and CDC will be responsible for the activities listed under 2. CDC Activities.

1. Recipient Activities

(a) Design and conduct research to address the described goals of this cooperative agreement. This may include formative research or pilot work.

(b) Collaborate with CDC in the development of the human subjects protocol for the CDC Institutional Review Board (IRB), implementation and evaluation of project delivery.

(c) Collaborate with CDC to write and disseminate reports of research activities to regional, state, and local partners.

(d) Obtain approval of the study protocol by the recipient's local IRB.

(e) Collaborate with CDC to analyze data, perform cost analyses, and publish findings in peer-reviewed journals.

2. CDC Activities

(a) Provide scientific and technical assistance for the design and implementation of this research.

(b) Collaborate with the grantee in the development of a research protocol for IRB review by all collaborating institutions. The CDC's IRB will review the protocol initially and on an annual basis until the project is complete.

(c) Collaborate with the grantee in ensuring human subjects assurances are in place as needed.

(d) Participate in the analysis and dissemination of study findings.

(e) Monitor and evaluate the scientific and operational accomplishments of the project through conference calls, site visits, and review of technical reports.

(f) Provide cost analyses of the design and implementation of this research.

E. Content

Letter of Intent (LOI)

A LOI is optional for this program. The Program Announcement title and number must appear in the LOI. The narrative should be no more than two double spaced pages, printed on one side, with one inch margins, and unreduced font. The letter should identify the name of the principal investigator and briefly describe the scope and intent of the proposed research work. The letter of intent does not influence review or funding decisions, but the number of letters received will enable CDC to plan the review more effectively and efficiently.

Applications

The Program Announcement title and number must appear in the application. Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program plan. The narrative should be no more than 40 double spaced pages, printed on one side, with one inch margins, and unreduced font. The narrative should consist of, at a minimum, a Plan, Objectives, Methods, Evaluation and a detailed Itemized Budget.

F. Submission and Deadline

Letter of Intent (LOI)

On or before June 1, 2002, submit the LOI to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

Application

Submit the original and five copies of PHS-398 (OMB Number 0925-0001) and adhere to the instructions on the Errata Instruction Sheet for PHS 398. Forms are available at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm. Application forms must be submitted in the following order:

Cover Letter, Table of Contents, Application, Budget Information Form, Budget Justification, Checklist, Assurances, Certifications, Disclosure Form, Human Subjects Certification, Indirect Cost Rate Agreement, Narrative

On or before 5 pm Eastern Time June 24, 2002, submit the application to the Technical Information Management Section: 2920 Brandywine Road, Suite, 3000, Atlanta, Georgia 30341.

Deadline: Applications shall be considered as meeting the deadline if they are received before 5 pm Eastern Time on the deadline date. Applicants sending applications by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to the following (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will upon receipt of proper documentation, consider the application as having been received by the deadline.

Applications which do not meet the criteria will not be eligible for competition and will be discarded. Applicants will be notified of their failure to meet the submission requirements.

G. Evaluation Criteria

Applicants are required to provide Measures of Effectiveness (i.e., rigorous designs and direct measures of outcomes with extended follow-up). Rigorous designs could include experimental designs in which families, communities, or other units are randomly assigned tot he intervention group (with level to be determined by assessment) and control or comparison groups, or strong quasi-experimental designs in which families, communities, or other units are matched appropriately. Measures of Effectiveness must relate to the National Center for Injury Prevention and Control performance goal of reducing the risk of child maltreatment.

Upon receipt, applications will be reviewed by CDC staff for completeness and responsiveness as outlined under the Eligible Applicants Section (Items 1-5). Incomplete applications and applications that are not responsive will be returned to the applicant without further consideration. It is especially important that the applicant's abstract reflects the project's focus, because the abstract will be used to help determine the responsiveness of the application.

Applications which are complete and responsive may be subjected to a preliminary evaluation (triage) by a peer review committee, the Injury Research Grant Review Committee (IRGRC), to determine if the application is of sufficient technical and scientific merit to warrant further review by the IRGRC; CDC will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator/program director and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated by a dual review process.

Competitive supplemental grant awards may be made if end of fiscal year funds are available, to support research work or activities not previously approved by the IRGRC. Competitive supplement applications should be clearly labeled to denote their status as requesting supplemental funding support. These applications will be reviewed by the IRGRC and the secondary review group.

All awards will be determined by the Director of the NCIPC based on priority scores assigned to applications by the primary review committee IRGRC, recommendations by the secondary review committee Advisory Committee for Injury Prevention and Control (ACIPC), consultation with NCIPC senior staff, and the availability of funds.

1. The primary review will be a peer review conducted by the IRGRC. All applications will be reviewed for scientific merit using current National Institutes of Health (NIH) criteria to evaluate the methods and scientific quality of the application. Factors to be considered will include:

(a) Significance. Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?

(b) Approach. Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the project include plans to measure progress toward achieving the stated objectives? Is there an appropriate work plan included?

(c) Innovation. Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge or advance existing paradigms, or develop new methodologies or technologies?

(d) Investigator. Is the principal investigator appropriately trained and well-suited to carry out this work? Is the proposed work appropriate to the experience level of the principal investigator and other significant investigator participants? Is there a prior history of conducting injury-related research?

(e) Environment. Does the scientific environment in which the work will be done contribute to the probability of success? Does the proposed research take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Is there an appropriate degree of commitment and cooperation of other interested parties as evidenced by letters detailing the nature and extent of the involvement?

(f) Ethical Issues. What provisions have been made for the protection of human subjects and the safety of the research environments? How does the applicant plan to handle issues of confidentiality and compliance with mandated reporting requirements, e.g., suspected child abuse? Does the application adequately address the requirements of 45 CFR part 46 for the protection of human subjects? (An application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.) The degree to which the applicant has met the CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. This includes:

1. The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation.

2. The proposed justification when representation is limited or absent.

3. A statement as to whether the design of the study is adequate to measure differences when warranted.

4. A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits.

(g) Study Samples. Are the samples sufficiently rigorously defined to permit complete independent replication at another site? Have the referral sources been described, including the definitions and criteria? What plans have been made to include women and minorities and their subgroups as appropriate for the scientific goals of the research? How will the applicant deal with recruitment and retention of subjects?

(h) Dissemination. What plans have been articulated for disseminating findings?

(i) Measures of Effectiveness. The Peer Review Panel shall assure that measures set forth in the application are in accordance with CDC's performance plans (See attachment 4). How adequately has the applicant addressed these measures?

The IRGRC will also examine the appropriateness of the proposed project budget and duration in relation to the proposed research and the availability of data required for the project.

2. The secondary review will be conducted by the Science and Program Review Committee (SPRS) from the ACIPC. The ACIPC Federal ex officio members will be invited to attend the secondary review and will receive modified briefing books (i.e., abstracts, strengths and weaknesses from summary statements, and project officer's briefing materials). Federal ex officio members will be encouraged to participate in deliberations when applications address overlapping areas of research interest so that unwarranted duplication in federally funded research can be avoided and special subject area expertise can be shared. The NCIPC Division Associate Directors for Science (ADS) or their designees will attend the secondary review in a similar capacity as the Federal ex officio members to assure that research priorities of the announcement are understood and to provide background regarding current research activities. Only SPRS members will vote on funding recommendations, and their recommendations will be carried to the entire ACIPC for voting by the ACIPC members in closed session. If any further review is needed by the ACIPC, regarding the recommendations of the SPRS, the factors considered will be the same as the factors that the SPRS considered.

The committee's responsibility is to develop funding recommendations for the NCIPC Director based on the results of the primary review, the relevance and balance of proposed research relative to the NCIPC programs and priorities, and to assure that unwarranted duplication of federally funded research does not occur. The Secondary Review Committee has the latitude to recommend to the NCIPC Director, to reach over better ranked proposals in order to assure maximal impact and balance of proposed research. The factors to be considered will include:

(a) The results of the primary review including the application's priority score as the primary factor in the selection process.

(b) The relevance and balance of proposed research relative to the NCIPC programs and priorities.

(c) The significance of the proposed activities in relation to the priorities delineated in the National Research Agenda.

(d) Budgetary considerations.

3. Continued Funding

Continuation awards made after FY 2002, but within the project period, will be made on the basis of the availability of funds and the following criteria:

(a) The accomplishments reflected in the progress report of the continuation application indicate that the applicant is meeting previously stated objectives or milestones contained in the project's annual work plan and satisfactory progress demonstrated through presentations at work-in-progress monitoring workshops.

(b) The objectives for the new budget period are realistic, specific, and measurable.

(c) The methods described will clearly lead to achievement of these objectives.

(d) The evaluation plan will allow management to monitor whether the methods are effective.

(e) The budget request is clearly explained, adequately justified, reasonable and consistent with the intended use of grant funds.

H. Other Requirements

Technical Reporting Requirements Applicants are required to provide Measures of Effectiveness that will demonstrate the accomplishment of the identified objectives of the cooperative agreement. Measures must be objective/quantitative, and must measure the intended outcome. These Measures of Effectiveness shall be submitted with the application and shall be an element of evaluation.

Provide CDC with original plus two copies of

1. Semiannual progress reports.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

Send all reports to the Grants Management Specialist identified in the “Where to Obtain Additional Information” section of this announcement.

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the announcement.

AR-1 Human Subjects Requirements

AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

AR-3 Animal Subjects Requirements

AR-4 HIV/AIDS Confidentiality Provisions

AR-5 HIV Program Review Panel Requirements

AR-6 Patient Care

AR-7 Executive Order 12372 Review

AR-8 Public Health System Reporting Requirements

AR-9 Paperwork Reduction Act Requirements

AR-10 Smoke-Free Workplace Requirements

AR-11 Healthy People 2010

AR-12 Lobbying Restrictions

AR-13 Prohibition on Use of CDC Funds for Certain Gun Control Activities

AR-14 Accounting System Requirements

AR-15 Proof of Non-Profit Status

AR-16 Security Clearance Requirement

AR-17 Peer and Technical Reviews of Final Reports of Health Studies—ATSDR

AR-18 Cost Recovery—ATSDR

AR-19 Third Party Agreements—ATSDR

AR-20 Conference Support

AR-21 Small, Minority, Women-Owned Businesses

AR-22 Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

This program is authorized under section 301, 317, and 391-394 of the Public Health Service Act, [42 U.S.C. sections 241, 247b, and 280b-280b-3], as amended. The Catalog of Federal Domestic Assistance number is 93.136.

J. Where To Obtain Additional Information

This and other CDC announcements can be found on the CDC home page Internet address—http://www.cdc.gov Click on “Funding” then “Grants and Cooperative Agreements.”

If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Angie N. Nation, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146. Telephone number [phone].

e-mail address: [e-mail].

For program technical assistance, contact:

Daniel Whitaker, Behavioral Scientist, Division of Violence Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway, NE., (K-60), Atlanta, GA 30341-3724. Telephone number: [phone]. e-mail address: [e-mail].

Dated: May 3, 2002.

Sandra R. Manning,

CGFM, Director, Procurement and Grants Office, Centers for Disease Control and Prevention.