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Administration for Children and Families

Administration on Children, Youth and Families - Family and Youth Services Bureau

Personal Responsibility Education Program Innovative Strategies (PREIS)

HHS-2021-ACF-ACYF-AP-1928

Application Due Date: 07/26/2021

Personal Responsibility Education Program Innovative Strategies (PREIS)

HHS-2021-ACF-ACYF-AP-1928

TABLE OF CONTENTS

Overview Executive Summary

I. Program Description II. Federal Award Information

III. Eligibility Information

1. Eligible Applicants

2. Cost Sharing or Matching

3. Other

IV. Application and Submission Information

1. Address to Request Application Package

2. Content and Form of Application Submission

3. Unique Entity Identifier and System for Award Management

(SAM)

4. Submission Dates and Times

5. Intergovernmental Review

6. Funding Restrictions

7. Other Submission Requirements

V. Application Review Information

1. Criteria

2. Review and Selection Process

3. Anticipated Announcement and Federal Award Dates

VI. Federal Award Administration Information

1. Federal Award Notices

2. Administrative and National Policy Requirements

3. Reporting

VII. HHS Awarding Agency Contact(s) VIII. Other Information

Department of Health & Human Services Administration for Children and Families

Funding Opportunity Title: Personal Responsibility Education

Program Innovative Strategies (PREIS) Announcement Type: Initial Funding Opportunity Number: HHS-2021-ACF-ACYF-AP-1928 Primary CFDA Number: 93.092 Due Date for Applications: 07/26/2021

Executive Summary

Notice:

Applicants are strongly encouraged to read the entire funding opportunity announcement (FOA) carefully and observe the application formatting requirements listed in Section IV.2. Content and Form of Application Submission.

For more information on applying for grants, please visit "How to Apply for a Grant" on the ACF Grants & Funding Page at https://www.acf.hhs.gov/grants/howto.

The Administration for Children and Families (ACF), Administration on Children, Youth and Families' (ACYF) Family and Youth Services Bureau (FYSB) will be accepting applications from local organizations and entities, including faith-based organizations, to pilot, implement, and test innovative adolescent pregnancy prevention strategies for the Personal Responsibility Education Program Innovative Strategies (PREIS) program. This program targets services to high-risk, vulnerable, and culturally underrepresented youth populations. This includes, but is not limited to, youth in foster care, runaway and homeless youth, youth with HIV/AIDS, victims of human trafficking, pregnant and parenting youth who are under 21 years of age and their partners, rural youth, and youth residing in high teen birth rate areas. Projects are required to: a) educate adolescents on both abstinence and contraception for the prevention of pregnancy and sexually transmitted infections (STIs), including HIV/AIDS, and b) implement at least three of the following six adulthood preparation subjects (APS): 1) healthy relationships, 2) adolescent development, 3) financial literacy, 4) parent-child communication, 5) educational and career success, and 6) healthy life skills. Successful applicants are expected to implement rigorous impact evaluations conducted by independent, third-party evaluators. Acceptable research designs include randomized controlled trials and strong quasi-experimental designs, which require assignment or designation to either an intervention group or a control/comparison group. A minimum of 20 percent of funding per year must be allocated towards rigorous impact evaluation activities.

I. Program Description

Statutory Authority http://www.acf.hhs.gov/grants/howto

PREIS is authorized and funded by Section 513 of the Social Security Act (42 U.S.C. § 713), as amended by Section 50503 of the Bipartisan Budget Act of 2018 (Pub. L. No. 115-123) extended by Division CC, Title III, Section 302 of the Consolidated Appropriations Act, 2021 (Pub. L. No. 116-260).

Description

BACKGROUND

The PREIS program supports the implementation and evaluation of innovative strategies that have not previously been evaluated through a randomized controlled trial or a quasi-experimental design to effectively educate youth on both abstinence and contraception for the prevention of adolescent pregnancy, STIs, including HIV/AIDS. Interventions must address at least three of six adulthood preparation subjects. PREIS programs address sexual risk and protective factors and target youth populations that are at the highest risk for pregnancy.

Over the past decade, there has been a 40 percent decline in the teen birth rate [1]. In 2018, the U.S. birth rate for persons ages 15–17 was 7.2 and for persons ages 18–19 was 32.3 births per 1,000 females, according to Centers for Disease Control and Prevention (CDC) data [2].

Although there has been a significant decline in the teen birth rate for all groups, disparities still exist. In 2018, the birth rate for American Indian/Alaska, Hispanic/Latino, Hawaiian/Pacific Islander, and African American youth was 29.1, 26.7, 26.5, and 26.3 births per 1,000 women respectively, and socioeconomically disadvantaged youth of any race or ethnicity experience the highest rates of teen pregnancy and childbirth [3]. In addition, the data show continued disparities in geographic regions with states in the South and specific cities showing either no changes or increases in teen birth rate. Additionally, the latest CDC data indicate that young people ages 15 to 24 account for half of new sexually transmitted diseases reported annually [4]. In 2017, individuals aged 13-24 accounted for 21 percent of all new HIV diagnoses.

PREIS programs address disparities in teen births and rising STI rates through the implementation and evaluation of innovative strategies that are designed to change sexual risk behaviors such as delaying sexual activity, increasing condom or contraceptive use, and reducing pregnancy. Although there is a growing body of research on teen pregnancy among general youth populations, gaps in both research and the availability of interventions related to various high risk and vulnerable youth populations remain. The purpose of the PREIS program is to build the evidence base for adolescent pregnancy prevention interventions that are effective with high risk and vulnerable youth populations and fill gaps with new promising program models.

Promoting Healthy Transitions to Adulthood Through Positive Youth Development FYSB is committed to promoting the positive behavioral health and social and emotional well-being of vulnerable young people through a strengths-based, positive youth development (PYD) approach. Historically, many youth programs concentrated on a specific problem behavior, like teen sexual activity, and involved narrowly focused interventions and HIV/AIDS, victims of human trafficking, pregnant women who are under 21 years of age and their partners, mothers who are under 21 years of age and their partners, and youth residing in areas with high birth rates for youth. Youth are defined as those who are 10-19 years old (42 U.S.C. 713(e)(4)), except in the case of pregnant and parenting youth, which may include youth under 21 years old. (42 U.S.C. 713(a) (1) (C) (III)).

FYSB recognizes additional youth populations who are the most high-risk or vulnerable for pregnancies and STIs, including HIV/AIDS, or otherwise have special circumstances including culturally underrepresented youth populations such as Hispanic, African-American, or Native American youth; systems-involved youth; rural youth; runaway youth; lesbian, gay, bisexual, transgender, and questioning youth; out of school youth; and fathers who are under 21 years of age. PREIS projects must be welcoming and accessible to all youth and their participation must be voluntary.

PREIS PROGRAM DESIGN

Under the PREIS program, the following requirements must be addressed:

1. Innovative strategies

2. Abstinence and contraception

3. Adulthood Preparation Subjects (APS)

4. Medically accurate information

5. Age appropriate information

6. Culturally appropriate information

7. Trauma-informed care

8. Referrals to healthcare and other services

Innovative Strategies PREIS programs strategies must be innovative. For the purposes of this FOA, this means “innovations are new products, programs, ideas or practices that are implemented, adopted or disseminated within groups, organizations or networks.” [8] Innovative strategies are those that are tailored to the targeted population for a specific outcome.

Interventions must target youth at high risk for pregnancy and address relevant risk and protective factors associated with sexual risk behaviors. Innovative strategies are broadly defined but may include those that:

Have technology and/or computer-based components (i.e., apps, web-based learning, gaming)

Are implemented in non-traditional settings (e.g., runaway and homeless youth shelters, foster care group homes, juvenile detention centers, faith-based settings)

Target hard to reach populations (e.g., runaway and homeless youth, foster care youth, pregnant and parenting youth, victims of human trafficking)

Use systems-level approaches (i.e., approaches that aim to affect not only the individual but also multiple levels such as family, community, and institution)

Applicants are expected to have prior experience implementing the proposed intervention.

Applicants should not propose interventions not fully developed or that they have not implemented. Pilot studies are acceptable evidence of prior implementation. Proposed interventions must be grounded in a solid theoretical framework.

Proposed interventions must have relevant process evaluation findings and promising evidence of effectiveness but must not have been previously rigorously evaluated. This means that interventions that have been evaluated using a randomized controlled trial or quasi-experimental study are not eligible for PREIS funding.

Promising evidence of effectiveness includes descriptive studies on the proposed interventions that demonstrate significant quantitative outcomes related to attitudes, intentions, or behaviors as demonstrated through references to journal articles, studies, or data.

Abstinence and Contraception PREP programs must include activities to educate youth on both abstinence and the use of contraception and must place substantial emphasis on both abstinence and contraception for the prevention of pregnancy and STIs, including HIV/AIDS among youth. Programs should always place the optimal health of each youth at the forefront, with the focus on providing information and skills and the goal of helping them maintain or regain healthy decision-making that avoid risk behaviors and improve their opportunities for future thriving and success.

Adulthood Preparation Subjects PREIS grantees are to combine abstinence and contraceptive education with programming designed to support youth’s successful transition to adulthood. The requirement of incorporating APS supports preparation of youth for this transition through inclusion in the implementation of PREIS programs. Furthermore, grantees and/or subrecipients are required to address at least three of the following six APS subjects:

1. Healthy relationships, including marriage and family interactions.

2. Adolescent development, such as the development of healthy attitudes and values about adolescent growth and development, body image, racial and ethnic diversity, and other related subjects.

3. Financial literacy.

4. Parent-child communication.

5. Educational and career success, such as developing skills for employment preparation, job seeking, independent living, financial self-sufficiency, and workplace productivity.

6. Healthy life skills, such as goal setting, decision-making, negotiation, communication and interpersonal skills, and stress management.

Topics must be tailored and developed in appropriate ways to reflect the cultural, linguistic, and regional practices of the target population and the communities they serve. For more information on implementing APSs in PREP programs, please see the report on “Conceptual Models for Adulthood Preparation Subjects within the Personal Responsibility Education Program (PREP)” at https://www.acf.hhs.gov/sites/default/files/documents/opre/conceptual-models-adulthood-prep-feb-2021.pdf and the “Adulthood Preparation Subjects Resource Guide” at https://teenpregnancy.acf.hhs.gov/resources/adulthood-preparation-subjects-resou rce -guide-0 Medically Accurate Information PREIS programs must provide “medically accurate and complete” information. For the purposes of this FOA, the term “medically accurate and complete” means verified or supported by the weight of research conducted in compliance with accepted scientific methods; and https://www.acf.hhs.gov/sites/default/files/documents/opre/conceptual-models-adulthood-prep-feb-2021.pdf https://www.acf.hhs.gov/sites/default/files/documents/opre/conceptual-models-adulthood-prep-feb-2021.pdf https://teenpregnancy.acf.hhs.gov/resources/adulthood-preparation-subjects-resource-guide-0 https://teenpregnancy.acf.hhs.gov/resources/adulthood-preparation-subjects-resource-guide-0

1. published in peer-reviewed journals, where applicable, or

2. comprising information that leading professional organizations and agencies with relevant expertise in the field recognize as accurate, objective, and complete (see 42 U.S.C. 713(e) (2)).

All programs must ensure that information, curricula, and program materials used for implementation are medically accurate, complete, and up to date, including topics such as abstinence, contraceptives, and STIs and/or HIV. Other relevant topics that may be included in the content of some interventions include anatomy, reproduction, and pregnancy and/or birth (for pregnant mothers). Programs must document the appropriate sources (e.g., CDC, National Institutes of Health, peer-reviewed journals) in all program materials.

Age Appropriate Information PREIS programs must provide age-appropriate information and activities. The term “age-appropriate,” with respect to the information in abstinence and pregnancy prevention, means topics, messages, and teaching methods suitable to ages or age groups of children and adolescents, based on developing cognitive, emotional, and behavioral capacity typical for the age or age group. Programs must verify that all final materials are age appropriate before the start of the implementation period.

Culturally Appropriate Information PREIS programs must use culturally appropriate interventions that incorporate the norms, beliefs, and values of the target population into programming. The proposed project should demonstrate cultural sensitivity and competence in providing social, linguistic, and culturally sensitive interventions with the target population.

Trauma-Informed Care PREIS programs must ensure the intervention and project activities are trauma informed.

Trauma-informed means that projects working with vulnerable youth should take into account the trauma and mental health needs of many young people who have experienced maltreatment, abuse, or exposure to violence. Childhood abuse, neglect, and exposure to other traumatic stressors, known as adverse childhood experiences (ACEs), are common. The short- and long-term outcomes of these childhood exposures include a multitude of health and social problems, including early initiation of sexual activity and teen pregnancy [9]. These ACEs have important implications for teen pregnancy.

In the context of PREIS programs, trauma-informed care is an approach that recognizes trauma’s general impact on participating youth and helps guide programming, so it avoids re-traumatizing youth and facilitates youth engagement in the programming. A trauma-informed approach means the project takes into account many areas of the program, which may include, but are not limited to, the staff’s approach to youth, the content of the intervention, the delivery or facilitation of the intervention, training for facilitators on how to identify signs of trauma, and the referral and follow-up process for youth who exhibit signs of trauma. All programs should also create and maintain a “safe space” for youth, in an environment that is welcoming to all youth, inclusive, and non-stigmatizing. For additional information, please see the FYSB Trauma-Informed Care Tip sheet at https://www.acf.hhs.gov/opre/report/incor porating-trauma-informed-care-adolescent-pregnancy-prevention-programs.

https://www.acf.hhs.gov/opre/report/incorporating-trauma-informed-care-adolescent-pregnancy-prevention-programs https://www.acf.hhs.gov/opre/report/incorporating-trauma-informed-care-adolescent-pregnancy-prevention-programs

Referrals to Healthcare and Other Services PREIS programs must provide referrals for healthcare and other services, as needs are identified, but may not pay for the services with ACF/FYSB grant funding. As appropriate, programs should provide prevention-related referrals to other providers of healthcare services (e.g., substance abuse, tobacco cessation, physical health, mental health), local public health, and social service agencies. Programs are encouraged to develop partnerships to help facilitate these referrals and must document such referrals. When feasible, programs should track the initiation of service delivery. PREIS programs may only provide education to youth on the requirements provided in this FOA and the statute. (For more information, see Section IV.6, Funding Restrictions.)

PREIS PROGRAM TIMELINE

Project Timeline The PREIS program will be implemented in three phases. Programs are required to complete all activities in each phase before moving to the next one. Phase 1 will begin upon award of the grant and must be completed within the first 12 to 18 months of the grant award. Phase I activities will focus on implementation planning, evaluation planning and piloting the intervention. Grantees will conduct a pilot of one full cycle of the intervention using youth from the target population. The pilot will serve as a trial run of the delivery of the program and the implementation processes that are critical to the success of the project, such as recruitment, engagement, attendance, retention, and fidelity monitoring. During Phase I, programs will also work with FYSB to develop an implementation plan, an evaluation plan, obtain Institutional Review Board (IRB) approval, and develop and refine data collection instruments. Institutional Review Boards, or IRBs, review research studies to ensure that they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies, and adequately protect research participants. Grantees will be expected to include federal performance measures into their data collection instruments. The implementation and evaluation plans must be reviewed and approved by FYSB before the end of Phase 1. Grantees should expect several rounds of edits and modifications before approval. PREIS grantees will be expected to have an MOU or letter of agreement from all subrecipients and implementation sites at the time of application. All MOUs, contracts, and agreements should be finalized by the end of Phase I. MOUs with implementation sites must address both the implementation of the intervention and the rigorous evaluation study.

Phase II begins after all required activities from Phase 1 have been completed and approved.

All activities in this phase must be completed by the end of Year 4. Phase II activities will focus on the implementation and evaluation of the intervention. Once Phase II starts, programs may not make adaptations or modifications to the intervention materials or content that is delivered.

Grantees will conduct fidelity monitoring; process observations; obtain consent (and assent, when appropriate) and collect data from all cohorts of participants; and continue recruitment and retention, tracking, and follow-up efforts. Grantees will be expected to continuously monitor attrition through all data collection points, noting the reasons and number of participants who were not retained. Grantees will not be expected to conduct an implementation or process study. However, implementation will be expected to be documented and reported on in the final impact evaluation report.

Phase III begins upon the successful completion of Phase II activities and continues through the end of the project period. Grantees may propose to continue implementation with study sites/participants who have completed all follow-up data collection or with new sites/participants who were not involved in the study. This phase will focus on analysis and reporting, manualization and packaging of the intervention, sustainability, and dissemination of findings. Grantees will complete a lessons learned template, submit a final impact evaluation report, disseminate findings through local, regional, and/or national presentations, and submit at least one peer-reviewed manuscript. Grantees will be expected to manualize and package all intervention materials based on sources such as the program delivery documentation collected in Phase II. Grantees will not be expected to copyright, market, or disseminate the intervention.

All required activities for each phase are as follows:

Phase I (12 to 18 months)

Refine and/or revise intervention and training materials to ensure they are medically accurate, age appropriate, culturally appropriate, and trauma informed

Fill all staff vacancies and train staff to deliver the intervention Finalize Memoranda of Understanding (MOU)s, contracts, and agreements with partners, subrecipients, and implementation sites Develop and conduct cognitive testing with youth from the target population on the data collection instruments Include FYSB performance measures participant surveys in the final data collection instrument Obtain IRB approval for the pilot study Develop and receive approval for evaluation abstract, implementation plan, impact evaluation plan Obtain consent and assent forms from parents and participants for the pilot study Conduct a pilot test of the full intervention and implementation processes Incorporate changes to the intervention and implementation processes based on the pilot study

Phase II (Years 2-4)

Obtain IRB approval for the rigorous evaluation study Obtain consent and assent forms from parents and participants for the rigorous evaluation study Implement the intervention and activities for the control/comparison group (if applicable) Conduct fidelity monitoring and supervision activities Employ participant engagement and retention strategies to maximize attendance Conduct retention, tracking, and follow-up activities Collect and submit federal performance measures data to FYSB Collect impact evaluation data Complete CONSORT diagrams and baseline equivalence tables, as required Develop and finalize a sustainability approach

Phase III (Year 5)

Continue implementation of the intervention with youth outside of the study (as applicable)

Complete a lessons learned template Develop and finalize the analysis plan that supports the analysis of primary and secondary research questions Analyze all outcome data Submit and finalize an impact evaluation report to ACF Manualize and package all intervention materials Implement sustainability activities Submit at least one manuscript to a peer-reviewed journal to contribute to research Disseminate study findings

In order to transition into the next phase, PREIS programs must successfully complete all activities within the previous phase and receive approval from FYSB to move on to the next phase. For the purposes of this announcement, intervention materials are defined as all materials needed to implement all content, which includes, but is not limited to, training materials, PowerPoint slides, handouts, participant workbooks, videos, and app content.

NOTE: Consistent with the Paperwork Reduction Act (PRA) of 1995, (44 U.S.C. 3501-3521), under this FOA, FYSB will not conduct or sponsor, and a person is not required to respond to, a collection of information covered by such Act, unless it displays a currently valid Office of Management and Budget (OMB) control number.

PROGRAM EVALUATION OVERVIEW

PREIS programs will be expected to design and conduct a rigorous impact evaluation to determine the effectiveness of the innovative programs and/or approaches proposed on behavior change.

Rigorous Evaluation All PREIS evaluation designs must be rigorous in nature. Rigorous impact evaluations use one of the following two study designs to assess the impact of the intervention or approach:

randomized controlled trials (RCT) or high-quality, quasi-experimental designs (QEDs). Both designs require the following: 1) a treatment group that is eligible to receive the full intervention, and 2) a control/comparison group that will receive an alternative to the intervention or no intervention at all. RCTs require random assignment of participants (or classrooms) to either the treatment group or a control group. QEDs are used when random assignment is not feasible; however, participants are still designated to either the treatment or a comparison group. Grantees will be responsible for ensuring that all implementation sites understand the study design and agree to their proposed role in the design (e.g., treatment or control/comparison).

Research Questions PREIS programs will be expected to have both primary and secondary research questions. All research questions and the outcomes chosen to address these questions must align with the content that will be delivered to youth. Primary research questions must address outcomes related to at least one of the following behaviors that are outlined in the PREP legislation:

sexual activity, condoms or contraceptive use, or teen pregnancy. Primary outcomes related to sexual activity may include, but are not limited to, abstinence, cessation, and decreases in the frequency of sex.

Secondary research questions are factors that may have an indirect effect on sex risk behaviors.

These questions may include, but are not limited to, the following:

knowledge, attitudes, and skills related to sexual activity, condoms, contraceptive use, or teen pregnancy;

key variables in the theoretical framework for study intervention;

qualitative research related to sexual activity or program implementation;

adult preparation subjects as outlined in PREP legislation;

risk behaviors that co-occur with sexual risk-taking (i.e., substance use);

behaviors that are specific to the target population or geographic area, as identified by the literature or a recent needs assessment; and strengths or unique components of the overall program (i.e., mentoring, social emotional well-being, cultural identity).

Methodology PREIS programs will be expected to collect data at the following three time points: baseline, short-term follow-up (up to 6 months post intervention), and long-term follow-up (9 months or more post intervention). PREIS programs with pregnancy and birth rate outcomes are expected to have more extended short-term and long-term follow-up time points (e.g., 12 or 18 months).

Prior to data collection, all programs must obtain IRB approval from local institutions. These local institutions may be IRBs of partner universities or evaluation organizations. IRBs provide guidance regarding participant privacy and rights. General information about the HHS Protection of Human Subjects regulations can be obtained at http ://www.hhs.gov/ohrp. All plans for obtaining consent and assent, data collection, and storage must address confidentiality and privacy of the information collected.

PREIS programs will be expected to engage in extensive activities related to recruiting, retaining, and tracking participants throughout the project to obtain a sample size that supports adequate statistical power to detect program impact/effects. PREIS programs must ensure that staff have the adequate resources and time devoted to these efforts. For additional information on power analysis, see https://opa.hhs.gov/sites/default/files/2020-07/mdi-tabrief .pdf.

Program Implementation and Delivery In addition to a rigorous impact evaluation, PREIS programs will also be expected to use information collected under the program performance evaluation plan (see Section IV.2 The Project Description, Program Performance Evaluation Plan) and other sources to examine, in close detail, the function and form of the program services provided and the program delivery process with the goal of documenting the innovative strategy/approach that is being tested and how it was delivered. Programs must document changes in study processes, the environment, or the context that occurred and that may potentially influence study outcomes.

http://www.hhs.gov/ohrp https://opa.hhs.gov/sites/default/files/2020-07/mdi-tabrief.pdf

Evaluation Administration and Management PREIS programs must have separate leadership for program implementation and evaluation.

The leadership team of the PREIS program (e.g., Principal Investigator, Project Director) must include one person from the program whose primary responsibility is to oversee and manage program implementation and a separate person from the independent evaluation team whose primary responsibility is to oversee all evaluation activities.

The evaluation lead is expected to coordinate and manage a team to implement all evaluation activities, including, but not limited to, the following:

Developing all study processes and evaluation related plans, procedures, and materials for all phases of the project (see PREIS Program Timeline);

Training program staff and partners (as needed) on evaluation and study processes;

Obtaining IRB approval for all data collection efforts;

Developing and overseeing a continuous quality improvement process that is informed by data; and Working with program staff to develop approaches, strategies, and materials to clearly explain the study to key stakeholders such as program partners, parents, and youth.

The evaluation lead should designate specific staff for participant recruitment, screening, and enrollment, and specific staff for retention, tracking, and follow-up for both intervention and control/comparison groups throughout the study.

All evaluation activities must be conducted by an independent, third-party evaluator. Internal evaluators are not permitted. Independent evaluators may be universities, research organizations, evaluation consultants, or other institutions with experience in conducting rigorous impact evaluations that are similar in scope and size to the intervention or approach proposed by the applicant.

All PREIS programs will be required to set aside at least 20 percent of their PREIS budget for evaluation purposes. Where necessary and following appropriate consultation, FYSB may work with projects to adjust the level of evaluation funding post award to ensure the RCT or QED is adequately funded.

POST AWARD REQUIREMENTS

The acceptance of federal funds under this FOA will signify agreement by the grantee that it will comply with the following requirements:

Participate in a new grantee orientation webinar. The webinar will be held shortly after the official award date.

Conduct a pilot of one full cycle of the intervention and implementation processes with youth from the target population by the end of Phase I.

Submit all program and training materials to FYSB for medical accuracy review and complete recommended revisions prior to Phase II program implementation.

Have facilitators/educators formally trained in the program model by professionals who can provide follow-up technical assistance throughout the project period to facilitators.

Provide assurance that the grantee will obtain a sample size that supports adequate statistical power to detect program impact/effects.

Obtain IRB approval from local institutions for the pilot and the evaluation study, which includes PREP performance measures and measures associated with the rigorous impact evaluation by the end of Phase I.

Have Phase 2 project activities operating within at least 18 months following the Notice of Award.

Submit and receive approval from FYSB for evaluation-related plans and reports, including but not limited to the following: evaluation abstract, implementation plan, data analysis plan, lessons learned, baseline equivalence tables, CONSORT diagrams, an impact evaluation plan, and a final impact evaluation report. Plans and reports will be submitted using templates that are subject to Office of Management and Budget (OMB) approval under the Paperwork Reduction Act (PRA). FYSB will obtain OMB approval prior to use. For more information, please reference Section I. Program Description, Post-Award Requirements, Rigorous Evaluation.

Submit a manuscript related to the PREIS project to a peer-reviewed journal.

Collect and submit all federally developed PREP performance measures (including grantee and subrecipients).

Participate in evaluation activities to include FYSB contracted technical assistance for local evaluations that relate to this FOA.

Submit all federally required program and financial reports in the recommended format

(to be provided) in a timely manner to the Federal Project Officer and Grants Management Specialist (as requested).

Budget annually the cost of sending three key staff persons to attend a 3-day national adolescent pregnancy prevention annual grantee conference and two staff to attend one of two 2 1/2-day topical trainings. If travel is restricted at the federal or state level, the grantee should rebudget these costs. The key staff in attendance at the annual conference must include one of the lead program staff and one of the lead evaluation staff who is integrally involved in the collection of performance measures and the local evaluation data.

Pursuant to the data rights provision of the grants regulations, 45 CFR 75.322(d), ACF has the right to ask for data collected with ACF grant funding. The Federal

Government has the right under 45 CFR 75.322(d) to obtain, reproduce, publish, or otherwise use the data produced under a federal award; and to authorize others to receive, reproduce, publish, or otherwise use such data for federal purposes.

Medical Accuracy Review During Phase I, programs must submit all program materials for both the intervention and control/comparison groups to FYSB for a formal review for medical accuracy and completeness. These materials include, but are not limited to, teacher manuals, student booklets, scripts and role plays, videos, podcasts, Power Point presentations, posters, pamphlets, and handouts. During this review process, grantees will be notified of any content that needs to be modified, updated, or corrected. Programs must comply with these recommendations. Programs will not be able to use any materials until after the medical accuracy review is complete and all required modifications have been made. Programs will be expected to obtain approval and finalize all program materials prior to beginning of the implementation period in Phase II.

Programs will not be permitted to make changes to materials after final approval.

PREP Performance Measures All grantees and sub-recipient(s), including their implementation sites, will be required to collect and report information on program implementation and program outcomes through a common set of performance measures. This requirement applies to any community partners who agree to host a site or recruit program participants (e.g., school districts, non-profits). ACF does not intend to use performance measures to assess program effectiveness or impact. The purpose of the performance measures is to monitor and provide feedback about whether grantees are implementing PREP programs as intended and to demonstrate progress towards expected objectives. Performance measures can also create a foundation for program improvement efforts, prompted by federal, grantee, and program providers’ examination of the data.

PREP performance measures will be distributed to grantees and funded recipients, who will be required to collect and report on these measures approximately twice a year. ACF has defined measures at the grantee, provider, and program levels. For some performance measures, grantees provide data about activities they undertake directly at the grantee level. For other measures, data are based on information about each separate provider that serves youth directly (i.e., provider level) or each program model that a provider is implementing (i.e., program level). A program model is defined as the core curriculum plus other lessons or activities that may be integrated with the core curriculum to meet the PREP requirements. In addition, data are also collected from the youth themselves through participant entry and exit surveys. Ultimately, grantees are responsible for submitting performance measures from the grantee, provider, and program levels to ACF.

The following are the three categories of PREP performance measures for data collection and submission:

Structure, cost, and support for program implementation;

Attendance, reach, and dosage; and Participants’ characteristics, behaviors, program experiences, and perceptions of effects

(through participant entry and exit surveys).

Applicants applying for funds must indicate their agreement to collect the PREP performance measures and submit the data to ACF. Grantees will be expected to check local and state laws, policies, and procedures to ensure that the collection of performance measures data is feasible and obtain any necessary permissions (e.g., formal agreements with partners, IRB approval, copies of school district approvals) to collect these data. Grantees are responsible for ensuring all sub-recipients and implementation sites collect and submit the PREP performance measures.

FYSB will provide training on how to conduct performance measures data collection and reporting. Grantees may develop additional indicators of program performance, as needed, including adding items to the entry or exit surveys. However, all FYSB OMB-approved items must be administered first, in the order presented in the approved survey, before any additional items are added. Any additional survey items should be added at the end of the OMB-approved survey and should not be submitted to ACF.

For more information about the PREP performance measures, including definitions, survey instruments, and data collection tools, please see https://www.prepeval.com/DataCollectionToolsAndGuidance.html NOTE: Consistent with the Paperwork Reduction Act (PRA) of 1995, (44 U.S.C. 3501-3521), under this FOA, ACF will not conduct or sponsor, and a person is not required to respond to, a collection of information covered by such Act, unless it displays a currently valid OMB control number. ACF has obtained OMB approval (OMB Control Number 0970-0497;

Expiration Date June 30, 2023) under PRA to request and collect performance measures.

For more information on project requirements specific to this FOA, please refer to Section IV.2. The Project Description.

GLOSSARY OF TERMS

For purposes of this FOA, the following definitions are applicable:

Activities – All the actions needed to prepare for and carry out the project. This includes program and financial management, intervention activities, partnership activities, hiring and training activities, evaluation activities, and staff debriefings.

Age-appropriate – The term “age-appropriate,” with respect to the information in adolescent pregnancy prevention, means topics, messages, and teaching methods suitable to particular ages or age groups of children and adolescents based on developing cognitive, emotional, and behavioral capacity typical for the age or age group. (See 42 U.S.C. 713(e) (1).)” Organizational Capacity – The resources (i.e., staff, skills, facilities, finances, technology, partnerships, capabilities, and other resources) an organization has to have to implement a program.

Core Components – Program characteristics that must be kept intact when an intervention is being replicated or adapted for it to produce program outcomes similar to those demonstrated in the original research that provided evidence for effectiveness.

Continuous Quality Improvement – A continuous effort to assess on an ongoing basis to measurably improve the efficiency, effectiveness, performance, outcomes, and other indicators of quality in the services or processes Dissemination – The distribution of program information and findings with the aim of encouraging program interest, support, and adoption in real-world service systems or communities.

Effectiveness – The impact of a program under conditions that are likely to occur in a real-world implementation.

Evidence-based – Interventions, strategies, approaches, and/or program models that have been evaluated using rigorous impact research designs such as randomized controlled trials or high-quality, quasi-experimental studies that have demonstrated positive impacts for youth, families, or communities.

Fidelity – The degree to which an intervention is delivered as designed. Facilitator adherence to curriculum or program implementation guidelines; that is, how well the program is implemented without compromising the core content that is essential for program effectiveness.

https://www.prepeval.com/DataCollectionToolsAndGuidance.html

Impact Evaluation – Impact evaluation is a form of outcome evaluation that assesses the net effect of a program by comparing program outcomes with an estimate of what would have happened in the absence of the program. This form of evaluation is employed when external factors are known to influence the program’s outcomes in order to isolate the program’s contribution to achievement of its objectives.

Implementation – The process of introducing and using interventions in real-world service settings, including how interventions or program are adopted, sustained, and taken to scale.

Inputs – The resources needed to accomplish the goals of the project.

Innovation – New products, programs, ideas, or practices that are implemented, adopted, or disseminated within groups, organizations, or networks.

Institutional Review Board-- Institutional Review Boards, or IRBs, review research studies to ensure that they comply with applicable regulations, meet commonly accepted ethical standards, follow institutional policies, and adequately protect research participants.

Logic Model – A diagram that presents the conceptual framework for a proposed project and explains the links among program elements. Logic models must target the identified objectives and goals of the grant program.

Manualize and Package – To officially record all intervention materials into a written format that can be distributed.

Medically Accurate and Complete – Verified or supported by research conducted in compliance with accepted scientific methods; and published in peer-reviewed journals, where applicable, or comprising information that leading professional organizations and agencies with relevant expertise in the field recognize as accurate, objective, and complete. (See 42 U.S.C.

713(e)(2).)

Memorandum of Understanding (MOU) – A written agreement between the stakeholder organization or an individual and the applicant that describes the commitments and resources that both parties will provide to support the implementation of project activities.

Objectives – The specific and measurable actions that support the expected result of the program.

Outputs – The products and services provided as a result of the implementation of the activities.

Outcomes – The specific changes or results expected as a result of the program.

Performance Measures – Indicators that are designed to collect data for program monitoring, improvement, and reporting purposes.

Promising Evidence of Effectiveness – Descriptive studies on the proposed interventions that demonstrate significant quantitative outcomes related to attitudes, intentions, or behaviors as demonstrated through references to journal articles, studies, or data.

Quasi-Experimental Design Study – Evaluation design in which subjects enrolled in the intervention are matched to similar subjects that are not receiving the intervention (other quasi-experimental designs also exist). In quasi-experimental designs participants are not randomly assigned to treatment or control groups.

Randomized Controlled Trial (also known as a random assignment study) – Evaluation design in which individuals, families, classrooms, schools, and/or communities are randomly assigned to intervention and control groups.

Stakeholders – Individuals and organizations that have a shared interest in the program.

Stakeholders include participants, families, staff and volunteers, funders, and community organizations that share the program vision and are actively committed to the program.

Training and Technical Assistance – For the purposes of this FOA, the provision of training, advice, and/or assistance pertaining to the initiation, operation, or implementation of the proposed project activities.

Youth – An individual who has attained age 10 but has not attained age 20; pregnant women who are under 21 years of age and their partners; mothers who are under 21 years of age and their partners. (See 42 U.S.C. 713(e)(4).)

References [1] Martin J, Hamilton B, Osterman M, Driscoll A. (2019) Births: final data for 2018.

Hyattsville, MD: National Center for Health Statistics; 2019. https://www.cdc.gov/nchs/data /nvsr/nvsr68/nvsr68_13-508.pdf [2] Ibid.

[3] Ibid.

[4] Centers for Disease Control and Prevention. Sexually Transmitted Disease Surveillance 2018. Atlanta: U.S. Department of Health and Human Services; 2019. DOI:

10.15620/cdc.79370. https://www.cdc.gov/std/stats [5] Richard M., Lerner, R.M., Lerner, J.V., von Eye, A. Bowers, E.P., & Lewin-Bizan (2011).

Individual and contextual bases of thriving in adolescence: A view of the issues: Findings from the 4-H Study of Positive Youth Development. Journal of Adolescence, 34 (6), 1107–1114.

[6] Scher, L., Maynard, R.A., & Stagner, M. (2006). Interventions intended to reduce pregnancy-related outcomes among adolescents. Campbell Systematic Reviews.

[7] Gavin, L. E., Catalano, R. F., David-Ferdon, C., Gloppen, K. M., & Markham, C. M. (2010).

A Review of Positive Youth Development Programs That Promote Adolescent Sexual and Reproductive Health. Journal of Adolescent Health, 46(3, Supplement), S75-S91.

[8] McManus, A. Health promotion innovation in primary health care. The Australasian Medical Journal. 2013; 6(1):15-18. doi:10.4066/AMJ.2013.1578.

[9] Centers for Disease Control and Prevention: Adverse Childhood Experiences (ACE) Study, Major Findings http://www.cdc.gov/ace/findings.htm https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_13-508.pdf https://www.cdc.gov/nchs/data/nvsr/nvsr68/nvsr68_13-508.pdf https://www.cdc.gov/std/stats http://www.cdc.gov/ace/findings.htm

II. Federal Award Information Funding Instrument Type: Cooperative Agreement Estimated Total Funding: $9,600,000 Expected Number of Awards: 12 Award Ceiling: $900,000 Per Budget Period Award Floor: $600,000 Per Budget Period Average Projected Award Amount: $750,000 Per Budget Period Anticipated Project Start Date: 09/30/2021

Length of Project Periods:

Length of Project Period: 60-month project period with five 12-month budget periods

Additional Information on Awards:

Awards made under this announcement are subject to the availability of federal funds.

Applications requesting an award amount that exceeds the Award Ceiling per budget period, or per project period, as stated in this section, will be disqualified from competitive review and from funding under this announcement. This disqualification applies only to the Award Ceiling listed for the first 12-month budget period for projects with multiple budget periods. If the project and budget period are the same, the disqualification applies to the Award Ceiling listed for the project period. Please see Section III.3. Other, Application Disqualification Factors.

Note: For those programs that require matching or cost sharing, recipients will be held accountable for projected commitments of non-federal resources in their application budgets and budget justifications by budget period or by project period for fully funded awards, even if the projected commitment exceeds the required amount of match or cost share. A recipient's failure to provide the required matching amount may result in the disallowance of federal funds. See Section III.2. of this announcement for information on cost-sharing or matching requirements.

Applicants should provide a budget for the first 12-month budget period. Non-competing continuation awards will be offered for the remaining four budget periods of the project period based on the availability of funds, satisfactory progress of the grantee, and review and approval of the continuation applications.

The Grants Project Team (Grant Management Specialist, Federal Project Officer, and Technical Assistance Provider) will use the grantee’s semi-annual performance progress and financial reports, site visits, audit reports and other supporting documentation to determine, in accordance with the requirements in the PREIS FOA and statute, if satisfactory progress is being made. FYSB will factor in the grantee’s ability to meet the dues dates as identified in the FOA. The Grants Project Team’s review of reports and other documentation will be used to assess progress in: 1) accomplishing the project goals, objectives, and activities; 2) completing proposed activities; and 3) documenting allowable expenses that support project goals, objectives, and the approved budget. Please refer to Section VI.3. Reporting for more information on required reports.

Description of ACF's Anticipated Substantial Involvement Under the Cooperative Agreement

In cooperative agreement awards, the Federal Government is seen as a partner of the grantee and has substantial…

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