August 17, 2021
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
National Institute of Mental Health (NIMH)
This Notice of Special Interest (NOSI) informs current awardees that the National Institute of Mental Health (NIMH) is providing the opportunity to expand perinatal mental health research by funding administrative supplements to existing NIMH psychosocial prevention, treatment and mental health services intervention research grants or to conduct secondary analyses of pre-existing data sets pertaining to perinatal depression and other mood and anxiety disorders during the perinatal period. These administrative supplements will provide funds to augment existing non-perinatal trial samples by enrolling women during the perinatal period or to support new analyses of pre-existing data from mental health treatment, prevention or services intervention research involving women in the perinatal period. Research proposed in the supplement must fall within scope of the parent grant.
BACKGROUND: Perinatal mental illnesses comprise mental disorders that occur during pregnancy or following childbirth. Perinatal depression is one of the most common complications of pregnancy and the post-partum period; and pregnant people with mood disorders, including bipolar disorder, are at increased risk for suicide and post-partum psychosis. Anxiety disorders are also prevalent in the perinatal period and are often co-morbid with depression. Perinatal mental illnesses are prevalent and associated with negative sequelae for both mothers and infants. Well-studied psychosocial interventions can provide effective evidence-based treatment (EBT) options for pregnant and lactating people with commonly occurring mental disorders, including individuals who decline or discontinue standard-of-care pharmacologic interventions during pregnancy and lactation.
Established as part of the 21st Century Cures Act, The Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), recommended inclusion and integration of pregnant and lactating women in the clinical research agenda. In January 2019, revisions to federal policy for the protection of human subjects were implemented, removing pregnant women as an explicit example of a “vulnerable population” requiring additional ethical scrutiny prior to participating in research.
RESEARCH OBJECTIVES: Arguments for adapting existing psychosocial interventions or testing novel psychosocial interventions specifically for perinatal women often lack empirical justification based on evidence of differential intervention outcomes between perinatal people and other people of childbearing age. Studies in response to this NOSI will help to build an evidence base to support an empirical understanding of similarities and differences between perinatal people and other people of childbearing age regarding mental health outcomes of preventive, treatment, or services interventions. Research supported by this NOSI should help to identify putative intervention mechanisms or drivers of differential outcomes between perinatal people and other people of childbearing age, thereby identifying targets for adapting or optimizing current interventions, or developing novel interventions in future studies. Lack of differential outcomes will also be informative. Intervention studies supported by the supplements should explore recruitment feasibility and the need for specialized safety assessment protocols for the inclusion of perinatal people in psychosocial intervention trials that are not specifically designed for perinatal people. A second objective is to collect data from across studies with the goal of generating sufficient sample sizes to allow comparisons of perinatal people to other people of childbearing age with respect to psychosocial intervention outcomes. This objective will be supported by sharing data and employing common data elements from current intervention trials or by analyzing existing data sets. NIMH will require data sharing in accordance with the Data Sharing Policy for the National Institute of Mental Health as described in NOT-MH-19-033 and strongly encourages applicants to use common data elements as described in NOT-MH-20-067. Measures should be selected to facilitate exploration of similarities and differences across perinatal and non-perinatal groups.
Description of circumstances for which administrative supplements are available.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
Budget: Applicants may request up to $250,000 Direct Costs but are limited to no more than the amount of the current parent budget.
Lauren D. Hill, PhD
National Institute of Mental Health (NIMH)