Confidentiality {27}
All participants will be assigned an anonymous study identification number at enrollment. Study IDs will be used on all instrumentation and will be linked to an individual’s identifying information by a master study key which will be maintained in hard copy locked in the principal investigator’s office. All hard copies of study files as well as videotapes of the recorded play sessions and audiotapes of the interview sessions and focus group discussions will be kept in locked cabinets in research personnel office. Data collection instruments (e.g., questionnaires, EMR abstraction tools), coded video data, and transcripts will omit names and identifiers that could potentially identify the participants. All electronic data files will be saved on a University password-protected, encrypted computer and be backed up daily. Documentation of data management procedures will be carefully maintained. No results will ever be reported in a personally identifiable manner.Each participant randomized to group WCC will have the opportunity to privately discuss any concerns about her child with the pediatrician before the group visit begins. The group WCC model of care is designed to promote greater breadth and depth of discussion, as well as increased focus on maternal wellness and social determinants of health. Therefore, it is possible that group discussion may bring forth sensitive topics, for example, intimate partner violence that could cause psychological distress for participants. Prior to each group WCC visit, the pediatrician will review group rules including confidentiality and the use of the session as a “safe space.” Any participant experiencing significant distress as a result of the discussion will be escorted from the room by one of the co-facilitators, and an on-site nurse manager or social worker at the SUD treatment program will be notified. In the case information is disclosed during group discussions about child abuse or neglect, intent to harm self, or intent to harm others, the pediatrician will follow standard reporting procedures as required by law.