NAS ABATEMENT PROGRAM GRANT APPLICATION

Please complete the contact information, grant application information, grant application questions, and sign the acknlowedgement. 

GRANT APPLICATION INFORMATION

Grant Application

(Sections 1-6 must not exceed 5 pages)

1. Significance & Specific Aims:

Please explain how the proposed NAS Abatement Program will address an important problem or a critical barrier to the understanding of NAS or the care of children with NAS. If the stated objectives of the proposed NAS Abatement Program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will the life chances, education, health, and wellbeing of children be improved? How will achieving of the stated objectives of the proposed NAS Abatement Program change the concepts, methods, technologies, treatments, services, or preventative interventions for NAS?

Successful applications will provide a compelling justification for the overall significance of the proposed NAS Abatement Program in terms of:

• how the geographic region that the proposed NAS Abatement Program intends to serve has been impacted by prenatal opioid use disorder;
• the occurrence of NAS in infants born in the geographic region that the proposed NAS Abatement Program intends to serve;
• the target population (e.g., the number of affected individuals, the depth of intended impact, the associated severity of symptoms or disability, and/or overall burden associated with unmet needs);
• the therapeutic/preventive interventions or services that will be utilized, including the potential for optimized preventive activities, intervention or service delivery strategies to substantially improve outcomes beyond existing approaches (as they exist in the target community);
• the anticipated dissemination, adoption and sustained use of new approaches and innovations that can be achieved through partnerships (demonstrated through letters of support and formal Memoranda of Understanding); and
• the need for proposed NAS Abatement Program to either advance scientific understanding, design preventive measures, improve adherence to treatment plans, or improve clinical care.

2. Investigators

3. Innovation

Please note how the proposed NAS Abatement Program challenges and seeks to deepen, broaden or shift current research or clinical practice paradigms for (a) encouraging success in school, (b) addressing emotional, behavioral, developmental, psychological, social, or learning problems experienced by NAS children, by utilizing novel theoretical concepts, approaches, partnerships, methodologies, instrumentation, or interventions, (c) improving the outcomes for the mother-child dyad, (d) comprehensive assessment of children and/or families, (e) providing medical care access or medical care coordination to birth mothers, children, and their families, (f) educating birth mothers and potential birth mothers of the risks and dangers of opioid use during pregnancy, (g) counseling birth mothers and/or guardians with regard to best practices in caring for NAS children, and/or (h) identifying and providing access to necessary services for individual families.

4. Approach

Questions:

Successful applications will demonstrate an overall strategy, methodology, and analyses (intended outcomes, indicators of progress and impact, etc.) that are well-reasoned and appropriate to accomplish the specific aims of the proposed NAS Abatement Program.  What strategies will the proposed NAS Abatement Program implement to ensure a robust and unbiased approach, as appropriate for the work proposed?  Are potential problems, alternative strategies, and benchmarks for success presented? How will the proposed NAS Abatement Program identify risks and challenges and mitigate such risks and challenges? How will the proposed NAS Abatement Program maximize the reliability and replicability of the findings so that it may be translated in other settings or with other researchers/practitioners? 

To what extent does the overall approach of the proposed NAS Abatement Program take into account the perspective of relevant stakeholders/end-users and key characteristics of the settings that will implement optimized NAS studies or interventions so as to maximize cultural competence and resonance? Please explain how the proposed NAS Abatement Program will ensure that the resultant interventions and service delivery strategies are feasible, effective and scalable.

How adequate are the proposed NAS Abatement Program’s plans for sharing research resources (e.g., assessment and intervention protocols, software and/or programming for technology assisted approaches, data analytic strategies, de-identified data collected in research studies, etc.) with the scientific, policy, social welfare, public health, and child-serving communities?

Successful applications must adequately address potential ethical issues associated with the proposed NAS Abatement Program and ensure adequate attention to diversity, health equity, and inclusion issues such that participation in the proposed program activities mirrors the demographic composition and the social determinants of health among the community or populations affected with NAS or those at risk for developing NAS.

5. Environment

How will the environment in which the work of the proposed NAS Abatement Program will be conducted contribute to the probability of success? Are the institutional support, equipment, and other physical resources available adequate for the proposed NAS Abatement Program? How will the proposed NAS Abatement Program benefit from unique features of the scientific or clinical environment, participant populations, or collaborative arrangements?  Does the proposed NAS Abatement Program adequately address the capability and ability to conduct its operations at the proposed site(s) or centers? Does the proposed NAS Abatement Program have ties to and support from the local community, neighborhood, city, and county officials?

If multi-sites/centers are proposed, please provide evidence of the ability of the individual sites or centers to effectively collaborate with one another.

6. Data Collection:

Will a pre-existing data collection system be used in connection with the proposed NAS Abatement Program or will a new system have to be developed? What evidence is available to demonstrate ability to adhere to timely and complete data-submission schedules, in addition to ensuring that the data collected and transmitted is accurate? What systems are in place to show progress towards interim and final outcomes? How will the data outcomes of the proposed NAS Abatement Program be compared to similar programs?

ACKNOWLEDGEMENTS

The undersigned does hereby agree and acknowledge that in the event of an award of a NAS Abatement Grant: (A)  the award of a NAS Abatement Grant does not constitute a contractual agreement between it and the NAS Abatement Trust; that the amount of such NAS Abatement Grant and/or any related NAS Abatement Distribution will be made from a fund established for such purpose by the NAS Abatement Trust, and that undersigned’s sole recourse is to such fund, rather than to the Trust, its corpus or any other fund established by the Trust; that receipt by the undersigned of a NAS Abatement Grant and/or any related Abatement Distribution is conditioned upon execution and return by the undersigned of a “Grant Agreement” which shall contain, inter alia, the NAS Abatement Trust’s requirements for receipt and use of the NAS Abatement Grant and/or any related Abatement Distribution; and that no binding agreement shall arise as between the NAS Abatement Trust and the undersigned until such time as the NAS Abatement Grant and/or any related Abatement Distribution is received by the undersigned, at which time the Grant Agreement shall become effective; (B) the undersigned shall provide the Accountability Reports to the NAS Abatement Trust as such are generated for the purpose of enabling the NAS Abatement Trust to monitor the expenditures made from any awarded NAS Abatement Grant and/or any related Abatement Distribution; (C) the undersigned shall report, on a quarterly basis, the expenditures that are made from any awarded NAS Abatement Grant and/or any related Abatement Distribution, and to produce for review and Abatement by the NAS Abatement Trust, on a quarterly basis, all financial or internal documents which verify, account for and track such expenditures.

                                                                        By:                                                                             

                                                                        Print Name:                                                                

                                                                        Date:                                                                          

Applications should clearly detail:

Intervention Strategy

• The multi-level intervention strategy selected, including the elements or components of the strategy, the levels of the NIMHD framework being addressed, and the social determinants being targeted.
• The theoretical basis for the intervention strategy proposed.
• The multi-level intervention’s potential for sustainability, adoption and scaling up, after the study period ends.

Research Plan

• The primary and secondary outcomes being studied, including those related to opioid use and co-occurring conditions, early learning, infant and child development, supports and interventions for vulnerable child populations.
• A description of the measurement and analysis plan for the interim measures and outcomes identified.
• Deep grounding in, and connection with, target communities and populations (cultural competence, relationships, history of service, intervention and support).
• A description of the population or population subgroup proposed for the study and justification for its selection (e.g., data on trends in opioid use disorder in proposed communities and for specific populations, substance use overdose, or suicide risk)
• Plan to test mechanisms of action or mediational processes linking social determinants of health to study outcomes.
• Justification for selection of planned economic analysis, data sources, and analysis plan.
• Discussion of ethical considerations in the design and execution of the research (as relevant)

Research Team and Collaborators

• Evidence of research team members’ experience without duplicating information in bio-sketches conducting rigorous substance use and mental health-related prevention intervention research, the U.S. opioid crisis, health disparities/social determinants of health research, and community-engaged research.
• Evidence of commitment to participate in the research from the organizations or entities responsible for implementation of the intervention(s)
• Documentation of commitment of other partners who will provide access to data or research resources.