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Because infants\u2019 experiences are inextricably tied to their caregivers, an important target for mitigating \u201ctoxic\u201d stress exposure in early childhood is through reducing parents\u2019 experiences of chronic stress in addition to protecting children from direct experiences of harm such as physical or sexual abuse. Conducting screening to identify when children are exposed to early life adversity is a first step; connecting families to needed support services is an essential component to addressing identified challenges. This paper presents the methodology of a three-year study of health care systems innovations designed to engage and support parents of infants to prevent and mitigate children\u2019s toxic stress exposures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Key study features included: 1) multi-component study in five U.S. communities and nine pediatric health care clinics and the families they serve, 2) a developmental evaluation approach to describe how innovations are experienced over time at three levels\u2014community systems, pediatric providers, and families, and 3) rapid cycle feedback conducted with communities, clinics and families to co-interpret data and findings. Data sources included: 1) focus groups and interviews with community stakeholders, clinic staff, and families, 2) electronic health record and Medicaid services data extracted to assess health care quality, utilization, and financial impact, and 3) clinic-recruitment of 908 parents of infants in a longitudinal survey. Results. The sample is briefly characterized based on responses to the enrollment phase of the parent survey.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>We discuss the study design elements\u2019 contribution to generating evidence needed by innovators, communities, and clinics to modify and sustain investments in these innovations to prevent or mitigate the effects of exposure to toxic stress on young children.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s12913-021-06057-4","type":"journal-article","created":{"date-parts":[[2021,1,19]],"date-time":"2021-01-19T04:02:51Z","timestamp":1611028971000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["The Mitigating Toxic Stress study design: approaches to developmental evaluation of pediatric health care innovations addressing social determinants of health and toxic stress"],"prefix":"10.1186","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8113-7900","authenticated-orcid":false,"given":"Julie S.","family":"McCrae","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jo Ann L.","family":"Robinson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angeline K.","family":"Spain","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaela","family":"Byers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer L.","family":"Axelrod","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,1,19]]},"reference":[{"key":"6057_CR1","volume-title":"Final Report of the Commission on Social Determinants of Health","author":"World Health Organization, Commission on Social Determinants of Health","year":"2008","unstructured":"World Health Organization, Commission on Social Determinants of Health. 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Participant consent procedures were approved by the SSA IRB. Written consent was obtained for all family and stakeholder interview participants. All focus group participants provided verbal consent. We obtained a waiver for written informed consent for the focus groups because the research presented no more than minimal risk of harm and involved no procedures for which written consent is normally required outside of a research context, and written consent would be the only record linking the subjects to the research. At each focus group, we asked subjects to affirm their agreement to participate in the study and to be recorded at the start of the audio recording.Families (adult parents\/caregivers) provided written consent for researchers to access electronic health record and Medicaid claims data. Data sharing agreements and business associate agreements for sharing protected health information were executed with each clinic, health system, or state Medicaid agency and approved by the SSA IRB and in the case of one clinic as required, their hospital system IRB.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"71"}}