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.

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.

Association between opioid overdose death rates and educational attainment - United States, 2010-2019.

Educational attainment may be an indicator of disparities in the ongoing opioid-overdose crisis. To understand the association between educational attainment and fatal opioid overdose, death records in the mortality files published by the Centers for Disease Control and Prevention (CDC) from 2010 to 2019 were analyzed. Proportionate mortality due to opioid overdose, PMOD, was used, as age-adjusted death rates suffer dual data-source errors caused by differences in educational data reported in death records and in population surveys. From 2013 to 2019, PMOD increased by 120% for the "less-than-high-school-diploma" (

Comprehensive and compassionate responses for opioid use disorder among pregnant and parenting women.

Pregnant and parenting women with opioid use disorder face multiple challenges to recovery. Trauma histories, poverty, stigma and discrimination, and lack of access to treatment intersect to marginalise this population. It is important that pregnant and parenting women with opioid use disorder receive comprehensive care to improve their health, the health of their child(ren), and prevent the intergenerational transmission of opioid and other substance use disorders. For nearly 50 years the Maternal Addiction Treatment, Education, and Research program has provided an evolving and expanding range of comprehensive services for treating opioid and other substance use disorders in this population. In this review the rationale for, and processes by which, key components of a comprehensive approach are discussed. These components include patient navigation for access to care, low-barrier medications for opioid use disorder, effective trauma-responsive therapy, prenatal and well-child healthcare, and other support services that make it possible for pregnant and parenting women to engage in treatment and improve the health of the entire family. Additionally, a method for supporting staff to build resilience and reduce fatigue and burnout is discussed. These components comprise an effective model of care for pregnant and parenting women with opioid and other substance use disorders.

Pregnant Smokers Receiving Opioid Agonist Therapy Have an Elevated Nicotine Metabolite Ratio: A Replication Study.

INTRODUCTION: Pregnant women exposed chronically to opioids smoked more cigarettes per day (CPD) and had a higher nicotine metabolite ratio (NMR), 3-hydroxycotinine/cotinine, a biomarker of nicotine metabolism and clearance, than those not receiving opioids. We examined CPD and NMR in a group of pregnant smokers, a quarter of whom were receiving opioid agonist therapy (OAT). AIMS AND METHODS: Pregnant smokers recruited to participate in a placebo-controlled trial of bupropion for smoking cessation provided a blood sample for measurement of NMR. RESULTS: Half (52.4%) of the 124 women with NMR data were African American. OAT-treated women (n = 34, 27.4%; 27 receiving methadone and 7 buprenorphine) were more likely to be white (79% vs. 30%, p < .001) and to have a lower mean PHQ-9 total score (2.91 [SD = 2.83] vs. 4.83 [SD = 3.82], p = .007). OAT-treated women reported smoking more CPD (9.50 [SD = 5.26] vs. 7.20 [SD = 3.65], p = .005) and had higher NMR (0.78 [SD = 0.36] vs. 0.56 [SD = 0.25], p = .001) than the non-OAT-treated group. In a linear regression analysis adjusting for race, depression severity, and CPD, NMR was greater in the OAT group (p = .025), among whom the daily methadone-equivalent dosage correlated with NMR (Spearman's ρ = 0.49, p = .003). CONCLUSIONS: Consistent with the findings of Oncken et al. (2019), we found that OAT smokers smoked more and had higher NMR than non-OAT smokers. As higher NMR is associated with a reduced likelihood of smoking cessation, the effects on NMR of both pregnancy and OAT could contribute to a lower smoking cessation rate in pregnant smokers receiving chronic opioid therapy. IMPLICATIONS: We replicated the finding that the NMR is significantly greater among pregnant smokers receiving OAT than those not receiving this treatment for opioid use disorder. Furthermore, we found that the dosage of the OAT was significantly associated with the NMR level. These findings may contribute to a poorer response to smoking cessation treatment in pregnant women treated with OAT, particularly those receiving high-dose therapy, and raise the question of whether novel approaches are needed to treat smoking in this subgroup of pregnant smokers.

Perceptions of Pediatric Primary Care Among Mothers in Treatment for Opioid Use Disorder.

To assess receipt of anticipatory guidance and family-centered care during well-child care (WCC) for children of mothers with opioid use disorder (OUD). Cross-sectional survey of 157 mothers receiving treatment for OUD who had a child < 3 years old and received primary care. Survey items evaluated (1) receipt of anticipatory guidance on 15 topics during WCC for the participant's child and (2) whether WCC was family-centered. The percentage of participants who reported guidance for each topic and the distribution of responses on family-centered items were calculated. A Pearson correlation was conducted to evaluate the association between the total number of topics for which anticipatory guidance was received and the family centeredness summary score. Receipt of anticipatory guidance varied by topic, ranging from 59% for guidance on childcare to 98% for guidance on safe sleep. Less than two-thirds of mothers reported that their child's provider "always" knew their child's medical history (56%), listened carefully (58%), clearly explained things (61%), and respected the mother (62%). Less than half reported that the provider spent enough time with them, and less than one-third reported that they were asked for their viewpoints. Anticipatory guidance and family-centeredness scores were positively correlated (r = 0.22, P = 0.006). Mothers with OUD report gaps in anticipatory guidance on important WCC topics, and limited family-centered care for their children. Further research may focus on refinements to the delivery of care for this population.

Application of a RE-AIM Evaluation Framework to Test Integration of a Mindfulness Based Parenting Intervention into a Drug Treatment Program.

Background The RE-AIM framework was applied to the Mindfulness Based Parenting (MBP) intervention to evaluate the feasibility and effectiveness of this innovative trauma informed model in a drug treatment program. The MBP intervention is aimed at mitigating the stress experienced by women in treatment for substance use disorders, and thereby improving parenting and dyadic attachment between mother and child. Methods This was a single arm pre-test post-test design using repeated measure data collected between 2013 and 2016. The design also includes comprehensive process and impact evaluation data. Participants were 120 parenting women enrolled in an opioid treatment program between 2013 and 2016 in Philadelphia, PA. The MBP intervention included weekly 2-h MBP group sessions over 12 weeks, including three dyadic sessions with their child. The main outcomes of this study include the five facets of RE-AIM: Reach, Effectiveness, Adoption, Implementation, and Maintenance. Results The MBP intervention was associated with improvements in parenting across participants. Data showed implementation and sustainability are contingent upon a strong multidisciplinary team and clinical staff support and "buy-in". Iterative adaptations of interventions used in the general population may be necessary when working with a traumatized population burdened by low literacy levels, trauma history and co-occurring disorders. Conclusions MBP is a feasible and effective intervention for improving parenting and dyadic attachment between women with opioid use disorder and their children, and may be useful for other programs that serve parenting women with substance use disorders.

E-cigarette use among women of reproductive age: Impulsivity, cigarette smoking status, and other risk factors.

INTRODUCTION: The study aim was to examine impulsivity and other risk factors for e-cigarette use among women of reproductive age comparing current daily cigarette smokers to never cigarette smokers. Women of reproductive age are of special interest because of the additional risk that tobacco and nicotine use represents should they become pregnant. METHOD: Survey data were collected anonymously online using Amazon Mechanical Turk in 2014. Participants were 800 women ages 24-44years from the US. Half (n=400) reported current, daily smoking and half (n=400) reported smoking <100 cigarettes lifetime. Participants completed questionnaires regarding sociodemographics, tobacco/nicotine use, and impulsivity (i.e., delay discounting & Barratt Impulsiveness Scale). Predictors of smoking and e-cigarette use were examined using logistic regression. RESULTS: Daily cigarette smoking was associated with greater impulsivity, lower education, past illegal drug use, and White race/ethnicity. E-cigarette use in the overall sample was associated with being a cigarette smoker and greater education. E-cigarette use among current smokers was associated with increased nicotine dependence and quitting smoking; among never smokers it was associated with greater impulsivity and illegal drug use. E-cigarette use was associated with hookah use, and for never smokers only with use of cigars and other nicotine products. CONCLUSIONS: E-cigarette use among women of reproductive age varies by smoking status, with use among current smokers reflecting attempts to quit smoking whereas among non-smokers use may be a marker of a more impulsive repertoire that includes greater use of alternative tobacco products and illegal drugs.

Using behavioral economic theory to increase use of effective contraceptives among opioid-maintained women at risk of unintended pregnancy.

OBJECTIVE: An unsettling aspect of the US opioid epidemic is the high rate of in utero exposure, especially since most of these pregnancies are unintended, due in part to low rates of effective contraceptive use among opioid-using women. This study tested an intervention informed by behavioral economic theory and aimed at promoting effective contraceptive use among opioid-maintained women at risk of unintended pregnancy in the Burlington, VT, area between 2011 and 2013. METHODS: Thirty-one women were assigned (initial 5 consecutively, subsequent 26 randomly) to either usual care or an experimental intervention. Participants in usual care received condoms, a dose of emergency contraception, and referral to local providers. Participants in the experimental condition received usual care plus the World Health Organization's contraception initiation protocol, including free prescription contraceptives, and financial incentives for attending 13 follow-up visits over 6months to help manage side effects and other issues. RESULTS: Significantly more women in the experimental vs. usual care control conditions initiated prescription contraceptive use (100% vs. 29%) and reported prescription contraceptive use at 1-month (63% vs. 13%), 3-month (88% vs. 20%), and 6-month (94% vs. 13%) assessments. None of the experimental condition participants became pregnant during the 6-month protocol vs. three women (20%) in the control condition. CONCLUSIONS: These results provide the first experimental evidence supporting the efficacy of an intervention for increasing prescription contraceptive use among opioid-maintained women at risk of unintended pregnancy.

Contraceptive use and method choice among women with opioid and other substance use disorders: A systematic review.

AIM: To systematically review the literature on contraceptive use by women with opioid and other substance use disorders in order to estimate overall contraceptive use and to examine method choice given the alarmingly high rate of unintended pregnancy in this population. METHOD: Pubmed (1948-2014) and PsycINFO (1806-2014) databases were searched for peer-reviewed journal articles using a systematic search strategy. Only articles published in English and reporting contraceptive use within samples of women with opioid and other substance use disorders were eligible for inclusion. RESULTS: Out of 580 abstracts reviewed, 105 articles were given a full-text review, and 24 studies met the inclusion criteria. The majority (51%) of women in these studies reported using opioids, with much smaller percentages reporting alcohol and cocaine use. Across studies, contraceptive prevalence ranged widely, from 6%-77%, with a median of 55%. Results from a small subset of studies (N=6) suggest that women with opioid and other substance use disorders used contraception less often than non-drug-using comparison populations (56% vs. 81%, respectively). Regarding method choice, condoms were the most prevalent method, accounting for a median of 62% of contraceptives used, while use of more effective methods, especially implants and intrauterine devices (IUDs), was far less prevalent 8%. CONCLUSIONS: Women with opioid and other substance use disorders have an unmet need for contraception, especially for the most effective methods. Offering contraception services in conjunction with substance use treatment and promoting use of more effective methods could help meet this need and reduce unintended pregnancy in this population.

Improving medicaid health incentives programs: lessons from substance abuse treatment research.

This commentary addresses the efforts of Medicaid programs in several US states to employ financial incentives to increase healthy behavior among their beneficiaries. While these Medicaid incentive programs have been successful at boosting rates of less effortful behaviors, like semiannual dental visits, they have fallen short in promoting more complex behaviors, like smoking cessation, drug abstinence, and weight management. Incentives have been extensively studied as a treatment for substance use disorders for over 20years, with good success. We identify two variables shown by meta-analysis to moderate the efficacy of incentive interventions in substance abuse treatment, the immediacy of incentive delivery and size (or magnitude) of the incentive, that are lacking in current Medicaid incentive program. We also offer some guidance on how these moderating variables could be addressed within Medicaid programs. This is a critical time for such analysis, as more than 10 states are employing incentives in their Medicaid programs, and some are currently reevaluating their incentive strategies.

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.

Standard Versus Rapid Inpatient Methadone Titration for Pregnant Patients With Opioid Use Disorder: A Retrospective Cohort Study.

OBJECTIVES: Our study evaluated if rapid inpatient titration of methadone for pregnant patients with opioid use disorder (OUD) improved outcomes without increasing the risk for overdose. METHODS: This is a retrospective cohort study of pregnant patients admitted for inpatient methadone titration from January 2020 to June 2022. Outcomes were compared between standard versus rapid titration protocols. Standard titration involved an initial methadone dose with additional doses every 6 hours if clinical opiate withdrawal score (COWS) is >9. Rapid titration involved an initial methadone dose with additional doses every 4 hours if COWS is >9. The primary outcome was time required to achieve stable dose. Secondary outcomes included elopement prior to achieving stable dose, methadone-related readmission, opioid overdose, and final dose. RESULTS: There were 97 patients in the standard titration (STP) and 97 patients in the rapid titration (RTP) groups. Demographic characteristics and substance use history did not differ between the 2 groups. Time to stable dose did not differ between the 2 groups (RTP, 5.0 days ±4.0; STP, 4.0 days ±3.0; P = 0.08). Patients in the rapid titration group were less likely to elope from the hospital prior to stabilization (RTP 23.0% vs STP 37.9%, P = 0.03) and had fewer methadone-related readmissions (P < 0.001). One patient (1.0%) in the RTP group required naloxone treatment while inpatient for concern for overdose, while none did in the STP group (P = 0.32). There was no difference in median final stable dose between the 2 groups (P = 0.07). CONCLUSIONS: Rapid titration of methadone for pregnant patients with OUD was associated with decreased medical elopement and methadone-related readmission, without increasing the risk for overdose.

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.

Scarce perinatal social support for women with OUD: Opportunities for doula services.

PROBLEM: Persons with opioid use disorder (OUD) often lack social support, which is associated with improved recovery outcomes. BACKGROUND: In the last two decades, the rate of opioid use disorder (OUD) among pregnant people has quadrupled. QUESTION: This study aimed to describe the prenatal and postpartum social support networks and needs of persons with OUD and assess perceived acceptability of community-based social supports such as doulas. METHODS: This mixed methods study utilized quantitative and qualitative data to understand social support structures and needs. Data was collected through surveys -demographics and social mapping; Adverse Childhood Experiences (ACE) tool; Connor Davidson Resilience 25-item (CDRS-25) scale- and a semi-structured interview. A total of 34 participants from a single urban opioid treatment program consented to participate. FINDINGS: Participants were on average 34.9 years old, White (64.7%), and unemployed (91.2%). Participants described small perinatal social support networks, which decreased in size from the prenatal to postpartum period. Only half (52.9%) reported adequate prenatal and postpartum social support. Doulas and peer recovery support specialists were perceived as valuable in perinatal health, social support, and recovery domains, with interest in doulas seen particularly amongst those with fewer reported supports. DISCUSSION: The scarcity of prenatal and postpartum social support among persons with OUD is critical to address, given the increased risk of relapse during the postpartum period which has implications for the maternal child dyad. CONCLUSION: Due to multiple disparities in prenatal and postpartum social support (small networks, inadequate support), doulas represent a trusted community-based support to be integrated into healthcare teams to address maternal morbidity/mortality associated with opioid use.

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.

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.

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.