Feasibility and acceptability of a community health worker administered behavioral activation intervention for postpartum depression: a single arm pilot study from India.

Introduction: Women in India experience high rates of postpartum depression (PPD), with minimal availability of screening or treatment. India has an extensive network of community health workers, known as accredited social health activists (ASHAs). While they are knowledgeable about most maternal-child health problems, they have minimal knowledge about PPD. We trained ASHAs to deliver a simple home-based intervention, behavioral activation (BA), which involves individuals in activities that are sources of positive reinforcement to counter depression. The research questions guiding this study were as follows: 1) What are the feasibility and acceptability of ASHAs screening for and delivering a brief behavioral activation intervention addressing PPD among women in Belagavi, South India? 2) What impact did the brief behavioral activation intervention have on PPD? Methods: The mixed methods evaluation used interviews with participants and interventionists, and depression scores were assessed before and after the evaluation. After a 2-day training with 17 ASHAs that focused on understanding PPD, screening using the Edinburgh Postnatal Depression Scale (EPDS), and implementing the BA protocol, ASHAs and researcher supervisors screened the mothers 6-12 weeks postpartum presenting at pediatric immunization clinics. Mothers who screened positive were invited to participate in an ASHA-led 5-week BA intervention, with ASHAs visiting the mothers' homes. We assessed post-intervention EPDS scores and conducted satisfaction assessments and individual interviews. Results: All 26 women who screened positive on the EPDS agreed to be enrolled in the study. All participants had a significant reduction (p < 0.001) in PPD scores. Both ASHAs and mothers had high enthusiasm for the intervention methods and activities. Discussion: This ASHA-delivered BA intervention was found to be feasible, acceptable, and effective in treating PPD in rural Indian mothers. This corroborates literature that demonstrates the efficacy of a BA intervention among individuals with generalized depression in South Asia. In communities with minimal mental health resources, interventions led by trained community workers have the potential to address PPD.

Perceptions of Primary Care Among Women in Treatment for Opioid Use Disorder: A Qualitative Study.

BACKGROUND: Underutilization of primary care and receipt of preventive health services have been reported among women with opioid use disorder. The aim of this study was to describe perceptions of primary care among women in treatment for opioid use disorder. METHODS: Between May and June 2022, 27 women who were receiving treatment for opioid use disorder from one opioid treatment program participated in this study. Participants completed one data collection session which involved a brief questionnaire followed by a semi-structured interview. Participants were asked questions about their overall experience with primary care as well as perceived facilitators and barriers to primary care utilization and quality. Interview transcripts were analyzed using an inductive thematic approach. RESULTS: Three themes emerged from the interviews within the domain of "Facilitators to Primary Care," including: (1) coordination of care, (2) continuity of care, and (3) relationship with health care providers. Four themes emerged from the interviews within the domain of "Barriers to Primary Care," including: (1) perceived judgment from health care providers, (2) childcare needs, (3) issues related to location, and (4) issues related to time. CONCLUSION: Approaches to primary care that help alleviate barriers to care and highlight the aspects of care that are valued may improve quality and utilization of care, thus enhancing the health and well-being of a vulnerable population.

A randomized double-blind pilot study to evaluate the efficacy, safety, and tolerability of intravenous iron versus oral iron for the treatment of restless legs syndrome in patients with iron deficiency anemia.

Restless legs syndrome (RLS) is a neurological disorder that can have a profound effect on sleep and quality of life. Idiopathic RLS is associated with brain iron insufficiency despite normal peripheral iron stores. There is, however, a five- to six-fold increase in prevalence of RLS in patients with iron deficiency anemia (IDA). Several open-label trials have demonstrated symptomatic improvement in RLS following treatment of IDA using oral or intravenous iron supplementation. To date, there have been no randomized double-blind controlled trials of intravenous iron compared with oral iron for the treatment of RLS patients with IDA. In the current study, oral ferrous sulfate and ferumoxytol were compared for efficacy and speed of response for treatment of RLS occurring in patients with IDA. The planned recruitment for this study was 70 patients with RLS and IDA, to be randomly assigned 1:1 to oral or intravenous iron, using double-blind, double-dummy procedures. At Week 6, the primary outcomes of Clinical Global Impression-Improvement score and change from baseline in the International Restless Legs Syndrome Study Group rating scale score were assessed. Due to challenges, performing the clinical trial during the COVID-19 pandemic, final-week data were found missing for 30 patients. As a result, in order to maintain the prespecified statistical analysis, an additional 30 patients were recruited. Both IV and oral iron were associated with a marked improvement in RLS symptoms, with no statistically significant difference between treatment groups. No serious adverse events were observed in either treatment group.

Group prenatal care for pregnant women with opioid use disorder: Preliminary evidence for acceptability and benefits compared with individual prenatal care.

INTRODUCTION: The effectiveness of group prenatal care (G-PNC) compared with individual prenatal care (I-PNC) for women with opioid use disorder (OUD) is unknown. The objectives of this study were to (1) assess the acceptability of co-locating G-PNC at an opioid treatment program and (2) describe the maternal and infant characteristics and outcomes of pregnant women in treatment for OUD who participated in G-PNC and those who did not. METHODS: This was a retrospective cohort study of 71 women (G-PNC n = 15; I-PNC n = 56) who were receiving treatment for OUD from one center and who delivered in 2019. Acceptability was determined by assessing the representativeness of the G-PNC cohorts, examining attendance at sessions, and using responses to a survey completed by G-PNC participants. The receipt of health services and healthcare use, behaviors, and infant health between those who participated in G-PNC and those who received I-PNC were described. RESULTS: G-PNC was successfully implemented among women with varying backgrounds (e.g., racial, ethnic, marital status) who self-selected into the group. All G-PNC participants reported that they were satisfied to very satisfied with the program. Increased rates of breastfeeding initiation, breastfeeding at hospital discharge, receipt of the Tdap vaccine, and postpartum visit attendance at 1-2 weeks and 4-8 weeks were observed in the G-PNC group compared with the I-PNC group. Fewer G-PNC reported postpartum depression symptomatology. CONCLUSION: Findings suggest that co-located G-PNC at an opioid treatment program is an acceptable model for pregnant women in treatment for OUD and may result in improved outcomes.

Maternal Perspective of Inpatient Methadone Initiation: Opportunities to Increase Retention in Treatment.

OBJECTIVES: Recent trends demonstrate increases in the rates of opioid use among pregnant and parenting women. Treatment for pregnant people with opioid use disorder (OUD) includes medications for OUD, like methadone, as well as comprehensive support services. Still, inpatient treatment engagement is suboptimal and treatment drop out is common. There is little research examining the maternal perspective of the inpatient methadone initiation experience. The primary aim of this qualitative methods study was to explore patient experience and perspective of the inpatient methadone initiation period. METHODS: All participants were recruited from a single urban university affiliated hospital and OUD treatment program. Data were collected from 30 maternal participants in OUD treatment about their inpatient methadone initiation experience while pregnant using semistructured interviews. Thematic analyses were conducted using an inductive approach after an iterative process of code development and application among a multidisciplinary team of 3 coders. Validity was accounted for through 2 participant feedback interviews and study team review and discussion of findings. RESULTS: Four themes emerged from the maternal interview data: (1) Barriers to Inpatient Methadone Initiation, (2) Facilitators to Inpatient Methadone Initiation, (3) Transition From Hospital Inpatient to Outpatient or Residential OUD Treatment Services, and (4) Opportunities for Enhanced Clinical Support. CONCLUSION: Maternal participants reported multiple barriers and facilitators to inpatient care during methadone initiation, highlighting opportunities for improvement to effectively engage pregnant individuals in treatment.

Priorities for Well Child Care of Families Affected by Parental Opioid Use Disorder.

BACKGROUND AND OBJECTIVES: Parenting women in treatment for opioid use disorder (OUD) report a lack of family centeredness and anticipatory guidance within well child care (WCC), and WCC utilization is low among affected children. We explore priorities for WCC visit content to inform primary care recommendations for this population. METHODS: This study is a qualitative study of parenting women from one urban, academic OUD treatment program and pediatric primary care clinicians from a nearby affiliated pediatric practice. Eligible parent participants had a child ≤2 years old and were English speaking. Semistructured interviews elicited perspectives on WCC, with questions and prompts related to visit content. Inductive thematic analysis was led by 2 investigators using open coding procedures. RESULTS: Among 30 parent participants, the majority were White (83%) and unmarried (90%). Approximately 60% reported their child received pharmacotherapy for neonatal opioid withdrawal syndrome. Of 13 participating clinicians, 9 were attending pediatricians. Five themes emerged from parental and clinician interviews: (1) improving knowledge and confidence related to child development, behavior, and nutrition; (2) mitigating safety concerns; (3) addressing complex health and subspecialty needs through care coordination; (4) acknowledging parental health and wellbeing in the pediatric encounter; and (5) supporting health education and care related to neonatal opioid withdrawal syndrome. Parents and clinicians expressed difficulty comprehensively addressing such issues due to time constraints, social determinants of health, and significant informational needs. CONCLUSIONS: Parenting women in treatment for OUD and pediatric clinicians share multiple priorities for anticipatory guidance within WCC visits and barriers to addressing them comprehensively.

RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study.

BACKGROUND: Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. It induces preterm births and low birth weight (LBW) deliveries, long-term neurodevelopmental sequelae, and an increased risk of earlier onset of postnatal iron deficiency. Anemia rates are among the highest in South Asia, and India's National Family Health Survey (NFHS-5) for 2019-2021 indicated that over half of pregnant women, and more than 65% of children, in the country are classified as anemic (Sciences IIfP, National Family Health Survey-5, 2019-21, India Fact Sheet). In 2021, the parent RAPIDIRON Trial (Derman et al., Trials 22:649, 2021) was initiated in two states in India, with the goal of assessing whether a dose of intravenous (IV) iron given to anemic women during early pregnancy results in a greater proportion of participants with normal hemoglobin concentrations in the third trimester and a lower proportion of participants with LBW deliveries compared to oral iron. As a follow-up to the RAPIDIRON Trial, the RAPIDIRON-KIDS Study will follow the offspring of previously randomized mothers to assess, neurobehavioral, hematological, and health outcomes. METHODS: This prospective observational cohort study will follow a subset of participants previously randomized as part of the RAPIDIRON Trial and their newborns. Study visits occur at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months and include blood sample collection with both maternal and infant participants and specific neurobehavioral assessments conducted with the infants (depending on the study visit). The primary outcomes of interest are (1) infant iron status as indicated by both hemoglobin and ferritin (a) at birth and (b) at 4 months of age and (2) the developmental quotient (DQ) for the cognitive domain of the Bayley Scales of Infant Development Version IV (BSID-IV) at 24 months of age. DISCUSSION: This RAPIDIRON-KIDS Study builds upon its parent RAPIDIRON Trial by following a subset of the previously randomized participants and their offspring through the first 3 years of life to assess neurodevelopmental and neurobehavioral (infants, children), hematological, and health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05504863 , Registered on 17 August 2022. Clinical Trials Registry - India CTRI/2022/05/042933 . Registered on 31 May 2022.

Group Well Child Care for Mothers with Opioid Use Disorder: Framework for Implementation.

OBJECTIVE: For parents with opioid use disorder (OUD) and their children, group well child care (WCC) is an under-studied intervention that may reduce stigma, increase quality of care, and improve clinical outcomes. We explored barriers and facilitators to this intervention using an implementation science framework. METHODS: A qualitative study was conducted from October 2020-March 2021 as part of the planning phase of a cluster-randomized trial of group WCC. Parent participants were recruited from one urban, university-affiliated OUD treatment center to participate in semi-structured telephone interviews. Eligible parents had a child under two years old and were English speaking. Clinician participants were recruited from a nearby pediatric primary care practice. Inductive thematic analysis of interview responses was led by two investigators using open coding procedures. RESULTS: Thirty-one parents and thirteen pediatric clinicians participated in the interviews. Most parents (68%) reported that they would be likely or very likely to bring their child to the OUD treatment center for WCC. Six themes emerged describing perceived implementation barriers, including intervention difficulty, complexity, and potential negative outcomes such as loss of privacy. Six themes emerged as implementation facilitators: (1) focus on parental OUD and recovery, (2) peer support, (3) accessibility and coordination of care, (4) clinician skill and expertise in parental OUD, (5) increased time for patient care, and (6) continuity of care. CONCLUSIONS FOR PRACTICE: Parents and clinicians expressed multiple perceived benefits of this intervention. Identified barriers and facilitators will inform implementation and evaluation of group WCC within one OUD treatment program.

Food Insecurity and Psychological Distress Amongst Parenting Women in Treatment for Opioid Use: Identifying Barriers to Nutritional Equity and Implications for Future Intervention Research.

PURPOSE: To describe the prevalence of food insecurity among pregnant and parenting women with opioid use disorder (OUD), its association with psychosocial health, and their experience with the Special Supplemental Nutrition Program for Women Infant Child (WIC) program. DESIGN: This cross-sectional study collected survey data through REDCAP. SETTING: The study was conducted at a single, urban, opioid treatment program. SUBJECTS: A total of 91 female participants (≥18 years of age and receiving OUD treatment services) were approached about the study and all consented. MEASURES: Measures included: US Household Short Form Food Security Survey, Patient Health Questionnaire 4(PHQ4), Perceived Stress Scale (PSS), and a demographics and food behavior survey. ANALYSIS: Descriptive analyses (frequency, means) described data and Chi-Square, Fischer's exact, t-tests were used to compare data between food security groups. RESULTS: Participants were on average 34 years old, Caucasian (68%), and non-Hispanic (87%). Most reported low (32%) to very low (33%) food security. Pearson correlation analyses indicate a strong positive linear relationship between Food Security Score and PHQ4 Total (P = .0002), PHQ4 Depression (P = .0003), PHQ4 Anxiety (P = .0009), and PSS Total (P < .0001). Only 38% felt the foods available in WIC supported their breastfeeding. Limitations include a single site and recall bias. CONCLUSIONS: Significant nutritional inequity in families affected by maternal substance use exists, with potential for adverse maternal and child development related implications.

Pediatric Primary Care Diagnoses Among Children with Intrauterine Opioid Exposure.

BACKGROUND AND OBJECTIVES: Characterizing common concerns for children with intrauterine opioid exposure (IOE) can inform tailored primary care. METHODS: Retrospective analysis of primary care data of children with IOE from birth to age two years within one multi-state pediatric health system. Well child care (WCC) and problem-based visit diagnoses were categorized, and descriptive statistics were tabulated. RESULTS: Three hundred and eighty-five (385) children with IOE had 3,622 primary care visits, of which 51.4% were WCC and 48.6% were problem-based. Most frequent visit diagnoses were upper respiratory complaints (14.8% of visits), feeding difficulties (12.2%), and perinatal viral exposure (9.8%). Although visit type (WCC vs. problem-based) varied across diagnostic category, frequent utilization of both visit types were documented for several diagnoses in infancy (e.g., fussiness/colic, feeding difficulties). CONCLUSIONS: Well child care visits for children with IOE are key opportunities for anticipatory guidance with an emphasis on problems that may contribute to acute health care utilization, particularly in early infancy.

The Child Healthcare at MATER Pediatric Study (CHAMPS): a 2-arm cluster randomized control trial of group well child care for mothers in treatment for opioid use disorder and their children.

BACKGROUND: Studies suggest that group-based well child care-a shared medical appointment where families come together as a group to receive pediatric primary care-increases patient-reported satisfaction and adherence to recommended care. Evidence supporting the use of group well child care for mothers with opioid use disorder, however, is lacking. The overall objective of the Child Healthcare at MATER Pediatric Study (CHAMPS) trial is to evaluate a group model of well child care for mothers with opioid use disorder and their children. METHODS: CHAMPS is a single-site 2-arm cluster randomized controlled trial. A total of 108 mother-child dyads will be enrolled into the study. Twenty-six clusters of approximately 4 mother-infant dyads each will be randomized 1:1 to one of two study arms (intervention or control). Clustering will be based on child's month of birth. In the intervention arm, group well child care will be provided on-site at a maternal substance use disorder treatment program. Mother-child dyads in the control arm will receive individual well child care from one nearby pediatric primary care clinic. Dyads in both study arms will be followed prospectively for 18 months, and data will be compared between the two study arms. Primary outcomes include well child care quality and utilization, child health knowledge, and parenting quality. DISCUSSION: The CHAMPS trial will provide evidence to determine if a group well child care offered on-site at an opioid treatment program for pregnant and parenting women is beneficial over individual well child care for families impacted by maternal opioid use disorder. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05488379. Registered on Aug. 04, 2022.

Outcomes of Menstrual Management Use in Transgender and Gender-Diverse Adolescents.

OBJECTIVE: To describe and compare the outcomes of various menstrual-management methods, including method choice, continuation, bleeding patterns, amenorrhea rates, effect on moods and dysphoria, and side effects, in transgender and gender-diverse adolescents. METHODS: This was a retrospective chart review of all patients seen in a multidisciplinary pediatric gender program from March 2015 to December 2020 who were assigned female at birth, had achieved menarche, and used a menstrual-management method during the study period. Data were abstracted on patient demographics and menstrual-management method continuation, bleeding patterns, side effects, and satisfaction at 3 months (T1) and 1 year (T2). Outcomes were compared between method subgroups. RESULTS: Among the 101 included patients, 90% chose either oral norethindrone acetate or a 52-mg levonorgestrel (LNG) intrauterine device (IUD). There were no differences in continuation rates for these methods at either follow-up time. Almost all patients had improved bleeding at T2 (96% for norethindrone acetate and 100% for IUD users), with no difference between subgroups. Amenorrhea rates were 84% for norethindrone acetate and 67% for IUD at T1 and 97% and 89%, respectively, at T2, with no differences at either point. The majority of patients had improved pain, menstrually related moods, and menstrually related dysphoria at both follow-up points. There were no differences in side effects between subgroups. There were no differences in method satisfaction between the groups at T2. CONCLUSION: Most patients chose norethindrone acetate or an LNG IUD for menstrual management. Continuation, amenorrhea, and improved bleeding, pain, and menstrually related moods and dysphoria were high for all patients, indicating that menstrual management is a viable intervention for gender-diverse patients who experience increased dysphoria related to menses.

Delivering clinical studies of exercise in the COVID-19 pandemic: challenges and adaptations using a feasibility trial of isometric exercise to treat hypertension as an exemplar.

The COVID-19 pandemic has significantly impacted on the delivery of clinical trials in the UK, posing complicated organisational challenges and requiring adaptations, especially to exercise intervention studies based in the community. We aim to identify the challenges of public involvement, recruitment, consent, follow-up, intervention and the healthcare professional delivery aspects of a feasibility study of exercise in hypertensive primary care patients during the COVID-19 pandemic. While these challenges elicited many reactive changes which were specific to, and only relevant in the context of 'lockdown' requirements, some of the protocol developments that came about during this unprecedented period have great potential to inform more permanent practices for carrying out this type of research. To this end, we detail the necessary adaptations to many elements of the feasibility study and critically reflect on our approach to redesigning and amending this ongoing project in order to maintain its viability to date. Some of the more major protocol adaptations, such as moving the study to remote means wherever possible, had further unforeseen and undesirable outcomes (eg, additional appointments) with regards to extra resources required to deliver the study. However, other changes improved the efficiency of the study, such as the remote informed consent and the direct advertising with prescreening survey. The adaptations to the study have clear links to the UK Plan for the future of research delivery. It is intended that this specific documentation and critical evaluation will help those planning or delivering similar studies to do so in a more resource efficient and effective way. In conclusion, it is essential to reflect and respond with protocol changes in the current climate in order to deliver clinical research successfully, as in the case of this particular study.

A training curriculum for an mHealth supported peer counseling program to promote exclusive breastfeeding in rural India.

BACKGROUND: Despite strong evidence about the benefits of exclusive breastfeeding, that is the baby receiving only breast milk, no other foods or liquids, rates have remained relatively unchanged over the past two decades in low- and middle-income countries. One strategy for increasing exclusive breastfeeding is through community-based programs that use peer counselors for education and support. The use of mobile health applications is also gaining increasing applicability in these countries. Minimal information is available about training peer counselors in the use of mobile technologies to support exclusive breastfeeding. The present article describes our curriculum in the state of Karnataka, India for supporting new mothers to exclusively breastfeed using a mobile health application in rural India. METHODS: Twenty-five women from the community surrounding the city of Belgavi, Karnataka, India were trained to be peer counselors and to use a mobile health application to conduct a structured curriculum to support new mothers in exclusive breastfeeding. The three-day interactive training, conducted in March 2018, was based on the WHO breastfeeding course, translated, and adapted to the local culture The curriculum, which included information collected during a formative research process, consisted of eight visits, two during the antenatal period and continuing for six months postpartum. Twelve nursing and obstetric experts validated curriculum content. Pre-post-evaluation of the training focused on breastfeeding knowledge, self-efficacy, skills, and app usability. RESULTS: We observed a significant increase in the mean scores for knowledge (P < 0.0001) and skills (P = 0.0006) from pre- to post-training. Age of the peer counselors and their own breastfeeding experience correlated significantly with the acquisition of knowledge and skills. The mobile health app showed high usability scores. CONCLUSIONS: The culturally adapted curriculum presented here, combined with an mHealth app, can be an important educational strategy for training rural women in the acquisition of exclusive breastfeeding knowledge and skills.

Opportunities to Increase Well-Child Care Engagement for Families Affected by Maternal Opioid Use Disorder: Perceptions of Mothers and Clinicians.

OBJECTIVE: Previous research suggests gaps in well-child care (WCC) adherence, quality, and effectiveness for children impacted by parental opioid use disorder (OUD). The objective of this study was to gather in-depth information regarding maternal and clinician-reported factors that enhance ("facilitators") or hinder ("barriers") WCC engagement as well as mothers' experiences during WCC visits. METHODS: Thirty mothers who were in treatment for OUD and 13 clinicians working at a pediatric primary care clinic participated in this qualitative study. All participants completed one data collection telephone session which involved a brief questionnaire followed by a semi-structured interview. Thematic analyses of the interview transcripts were conducted using an inductive approach. RESULTS: Three broad themes were identified as facilitators of WCC by mothers and clinicians, including: 1) continuity in care, 2) addressing material needs, and 3) clinician OUD training and knowledge. Themes identified as barriers to WCC included: 1) stigma toward mothers with OUD, 2) gaps in basic parenting knowledge, 3) competing specialized health care needs, and 4) insufficient time to address all concerns. CONCLUSION: WCC programs or clinical pathways designed for families affected by maternal OUD should consider these barriers and facilitators of WCC engagement and affect experiences of WCC for mothers and clinicians.

Design, Development, and Testing of BEST4Baby, an mHealth Technology to Support Exclusive Breastfeeding in India: Pilot Study.

BACKGROUND: Exclusive breastfeeding (EBF) at 6 months of age in most low- and middle-income countries, including India, is surprisingly low. There is a relative lack of mobile health apps that specifically focus on leveraging the use of peer counselors (PCs) to support mothers as a means of increasing EBF practices in low- and middle-income countries. OBJECTIVE: This study aimed to design, develop, and test the usability of Breastfeeding Education Support Tool for Baby (BEST4Baby), a mobile health app specifically designed to support PCs in providing in-home breastfeeding counseling support to mothers in rural India on optimal breastfeeding practices. METHODS: A user-centered design process with an agile development methodology was used. The approach involved stakeholders and mothers who were trained to serve as PCs to guide BEST4Baby's design and development, including the app's content and features. PCs were engaged through focus groups with interactive wireframes. During the 24-month pilot study period, we conducted a feasibility test of the BEST4Baby app with 22 PCs who supported home visits with mothers residing in rural India. The intervention protocol required PCs to provide education and follow mothers using the BEST4Baby app, with 9 scheduled home visits from the late prenatal stage to 6 months post partum. BEST4Baby's usability from the PCs' perspective was assessed using the translated System Usability Scale (SUS). RESULTS: The findings of this study align with best practices in user-centered design (ie, understanding user experience, including context with iterative design with stakeholders) to address EBF barriers. This led to the cultural tailoring and contextual alignment of an evidence-based World Health Organization breastfeeding program with an iterative design and agile development of the BEST4Baby app. A total of 22 PCs tested and rated the BEST4Baby app as highly usable, with a mean SUS score of 85.3 (SD 9.1), placing it over the 95th percentile for SUS scores. The approach translated into a highly usable BEST4Baby app for use by PCs in breastfeeding counseling, which also statistically increased EBF practices. CONCLUSIONS: The findings suggest that BEST4Baby was highly usable and accepted by mothers serving as PCs to support other mothers in their EBF practices and led to positive outcomes in the intervention group's EBF rates. The pilot study demonstrated that using the specially designed BEST4Baby app was an important support tool for mothers to serve as PCs during the 9 home visits. TRIAL REGISTRATION: Clinicaltrials.gov NCT03533725; https://clinicaltrials.gov/ct2/show/NCT03533725.

"You can't stop the waves, but you can learn how to surf": Realized mindfulness in practice for parenting women in recovery.

BACKGROUND: The opioid crisis is a public health issue, contributing to poor maternal child health outcomes. A Mindfulness Based Parenting (MBP) intervention, part of the "Practicing Safety Mindfulness Project for Mothers in Drug Treatment" (PSMDT) study, was previously tested as an intervention to mitigate stress and improve parenting domains in a sample of parenting women in treatment for substance use disorder. METHODS: Qualitative data from focus groups and Mindfulness Based Parenting group teacher process notes were analyzed to understand how participants applied mindfulness to their daily lives and how mindfulness affected their relationship with their child(ren). RESULTS: Thematic analyses revealed three overarching major themes: 1) Supportive Tools to Assist with Bringing Mindfulness into Daily Living; 2) Application of Embodied Tenets of Mindfulness to Perspective and Behavior and 3) Mindfulness Based Parenting and Recovery. Transference of mindfulness skills to parenting was evident through both focus group and process note data, illustrating how mindfulness behaviors were incorporated into family life. Data also revealed how tools utilized in the MBP intervention affected participant recovery. CONCLUSIONS: MBP intervention shows utility in improving parenting and recovery domains. Data from this study will inform future iterations of this intervention and this contextual analysis can be used to inform other recovery programs looking to utilize mindfulness as an adjunctive treatment.

Experiences with Menses in Transgender and Gender Nonbinary Adolescents.

STUDY OBJECTIVE: To describe menstrual history, associated dysphoria, and desire for menstrual management in transgender male and gender diverse adolescents who were assigned female at birth DESIGN: Retrospective chart review SETTING: Tertiary care children's hospital PARTICIPANTS: All patients seen in a multidisciplinary pediatric gender program from March 2015 through December 2020 who were assigned female at birth, identified as transgender male or gender nonbinary, and had achieved menarche INTERVENTION: None MAIN OUTCOME MEASURES: Patient demographics, menstrual history, interest in and prior experiences with menstrual management, parental support, and concerns about menstrual management RESULTS: Of the 129 included patients, 116 (90%) identified as transgender male and 13 (10%) as gender nonbinary, with an average age of 15 (SD 1.6) years. Almost all (93%) patients reported menstrual-related dysphoria. Most (88%) were interested in menstrual suppression. The most common reasons for desiring suppression were achievement of amenorrhea (97%) and improvement of menstrual-related dysphoria (63%). CONCLUSIONS: Most gender diverse patients assigned female at birth reported dysphoria associated with menses and desired menstrual suppression. This information can encourage physicians to raise this topic and offer menstrual management for gender diverse patients who experience distress related to menses, especially for those who are not ready for or do not desire gender-affirming hormonal treatment. Future research is needed to better understand patients' experiences with menses and to determine the optimal menstrual management methods. This could be an important intervention to improve outcomes for this vulnerable population.

Doula engagement and maternal opioid use disorder (OUD): Experiences of women in OUD recovery during the perinatal period.

BACKGROUND: Pregnant women who have substance use disorders (SUDs) are at increased risk of preterm birth, fetal mortality, and inadequate prenatal care and have higher rates of childhood trauma than their counterparts without SUDs. Doulas have been utilized with other vulnerable populations who experience trauma to increase perinatal healthcare utilization, provide emotional support, and improve birth outcomes. The objective of the current study was to examine, in women with opioid use disorder (OUD), perceptions of working with a doula in the perinatal period. METHODS: Eligible participants were ≥ 18 years old, in OUD treatment, and were pregnant or recently delivered (child ≤ 3 months of age). Semi-structured interviews were used to collect tacit data on the woman's experience working with a doula during the perinatal period. All one-hour interviews were conducted over the phone and transcribed verbatim by a HIPAA compliant transcription service. Transcripts were reviewed independently by 4 coders using open coding procedures, constant comparative method of grounded theory, and inductive thematic analysis. Demographic data and history of childhood trauma information (Adverse Childhood Experiences Tool) were collected with a phone survey prior to the interview. RESULTS: Participants' (N = 23) were 32.5 years of age (4.1 SD), with the majority Caucasian (71.4%), Non-Hispanic (71.4%) and Medicaid recipients (100%). Participants reported a mean of 5.61 (SD=2.93) adverse childhood experiences, indicating a significant trauma burden. Major themes uncovered in the interview transcripts revealed emotional and OUD recovery support provided by the doula and increased maternal health literacy and self-advocacy. The presence of a doula during labor/delivery reduced maternal perceptions of stigma they perceived from their healthcare providers. CONCLUSION: Doula engagement was associated with perceptions of increased emotional support, health literacy and self-advocacy in maternal health among women with OUD, which is significant given this population's trauma histories. This preliminary research has significant implications for improving the health of the mother child dyad affected by maternal OUD.