Group Well Child Care for Mothers with Opioid Use Disorder

(CHAMPS Trial)

Overseen By Hannah Steiger, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must be taking: Opioid treatment

Disqualifiers: Non-English speakers, Moving, Not parenting, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of providing healthcare for mothers undergoing treatment for opioid use disorder and their babies. It compares group well-child care, where mothers and babies meet healthcare providers together, to individual well-child care, where they meet providers one-on-one. The goal is to determine if the group approach improves health outcomes for both mothers and their infants. Mothers who are at least 28 weeks pregnant or have recently given birth, are currently in treatment for opioid use disorder, and plan to remain in the Philadelphia area for the next two years may be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions for mothers and infants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on care for mothers with opioid use disorder, so it's likely you can continue your current treatment.

What prior data suggests that this group well child care model is safe for mothers and infants?

Research has shown that group well child care (WCC) for mothers with opioid use disorder is a promising approach. Approximately 68% of parents report they would likely bring their child to these group sessions at their treatment centers, indicating that parents find the setting comfortable and supportive.

Currently, specific safety data for group WCC is limited. However, since this approach involves group sessions rather than a new drug or medical procedure, safety concerns are generally low. Group WCC focuses on providing social and emotional support to mothers and their children, which can improve overall care and reduce stigma.

Although detailed safety information is not available, the group care setup is designed to be safe and supportive for both mothers and their children, making it a low-risk option for participating families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the group well child care approach because it offers a unique support system for mothers with opioid use disorder. Unlike the standard individual well child care, this method creates a community setting where mothers can connect, share experiences, and gain peer support. This group dynamic may improve maternal and child health outcomes by fostering a sense of belonging and reducing isolation, which are often significant challenges for mothers facing addiction. By providing tailored support in a group environment, this approach has the potential to enhance both maternal engagement in treatment and child development.

What evidence suggests that group well child care is effective for mothers with opioid use disorder?

Research has shown that group well child care, which participants in this trial may receive, might benefit mothers with opioid use disorder and their children. This care reduces stigma and improves quality by enabling mothers to support each other while managing their children's health. Studies have found that many parents are willing to join, indicating they find this approach valuable. Group settings can also enhance health outcomes for both mothers and babies by fostering a supportive community. Although more research is needed, early results suggest promise for this care model. ^{1 3 4 5 6}

Who Is on the Research Team?

Vanessa Short, PhD

Principal Investigator

Thomas Jefferson University

Neera Goyal, MD

Principal Investigator

Nemours Al DuPont Pediatrics

Are You a Good Fit for This Trial?

This trial is for English-speaking mothers in treatment for opioid use disorder who are at least 28 weeks pregnant or less than 2 weeks postpartum, planning to parent their infant and stay in the Philadelphia area for two years. They should intend to seek pediatric care within Nemours/Thomas Jefferson University system.

Inclusion Criteria

Receiving treatment for opioid use disorder

Intent to remain in the Philadelphia area for the next 2 years

I am at least 28 weeks pregnant or within 2 weeks after giving birth.

Exclusion Criteria

I cannot speak English.

Plans to seek pediatric care outside of the Nemours/Thomas Jefferson University System

Plans to move outside of the Philadelphia area in the next 2 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline Assessment

Participants are enrolled and undergo baseline assessment immediately following enrollment

1 visit

1 visit (in-person)

Intervention

Participants receive either group or individual well child care, with assessments at 1, 6, 12, and 18 months of age

18 months

4 visits (in-person)

Follow-up

Participants are monitored for health and healthcare-related outcomes after the intervention

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Group well child care

Trial Overview The study compares group well child care with individual well child care over an 18-month period for mother-infant pairs where the mother is being treated for opioid use disorder. The goal is to see if group care better improves health outcomes by addressing specific needs of opioid-exposed infants.

How Is the Trial Designed?

Group I: Group well child care Experimental Treatment 1 Intervention

Individuals randomized to the intervention arm will participate in group well child care after birth hospital discharge.

Group II: Individual well child care Active Control 1 Intervention

Individuals randomized to the control arm will receive routine individualized well child care after birth hospital discharge.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Alfred I. duPont Hospital for Children

Collaborator

Trials

24

Recruited

5,030,000+

Published Research Related to This Trial

Parenting women in treatment for opioid use disorder (OUD) and pediatric clinicians identified key priorities for well child care (WCC) visits, including improving knowledge about child development and addressing safety concerns, which are crucial for the health of children affected by OUD.

Both groups acknowledged significant barriers, such as time constraints and social determinants of health, that hinder comprehensive discussions during WCC visits, highlighting the need for better support and resources in these healthcare encounters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Priorities for Well Child Care of Families Affected by Parental Opioid Use Disorder. Goyal, NK., Sood, E., Gannon, MA., et al.[2023]

A novel group prenatal care program for pregnant women with opioid use disorder combines prenatal care, substance use counseling, and medication-assisted treatment, showing improved satisfaction and adherence to care among participants.

Participants in the program reported increased trust in healthcare providers, better prenatal care experiences, and enhanced resilience against relapse, indicating that this model could lead to better outcomes for both mothers and their newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Prenatal Care for Women Receiving Medication-Assisted Treatment for Opioid Use Disorder in Pregnancy: An Interprofessional Approach. Sutter, MB., Watson, H., Bauers, A., et al.[2020]

The CHAMPS trial is evaluating the effectiveness of group-based well child care for mothers with opioid use disorder and their children, involving 108 mother-child dyads over an 18-month period.

This study aims to compare the quality and utilization of well child care, child health knowledge, and parenting quality between mothers receiving group care at a substance use treatment program and those receiving individual care at a pediatric clinic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Short, VL., Abatemarco, DJ., Sood, E., et al.[2023]

Mothers with opioid use disorder (OUD) reported significant gaps in anticipatory guidance during well-child care, with only 59% receiving guidance on childcare and 98% on safe sleep, indicating a need for improved education on various topics.

Family-centered care was lacking, as less than two-thirds of mothers felt their child's provider adequately knew their child's medical history or listened to them, highlighting the importance of enhancing communication and involvement in care for families affected by OUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Pediatric Primary Care Among Mothers in Treatment for Opioid Use Disorder. Short, VL., Goyal, NK., Chung, EK., et al.[2020]

A qualitative study involving 30 mothers in treatment for opioid use disorder and 13 clinicians identified key facilitators for well-child care (WCC) engagement, including continuity of care, addressing material needs, and clinician training on opioid use disorder.

Barriers to WCC included stigma against mothers with opioid use disorder, gaps in parenting knowledge, competing health care needs, and insufficient time during visits, highlighting the need for tailored WCC programs for these families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opportunities to Increase Well-Child Care Engagement for Families Affected by Maternal Opioid Use Disorder: Perceptions of Mothers and Clinicians. Short, VL., Gannon, M., Sood, E., et al.[2023]

A qualitative study involving 31 parents with opioid use disorder and 13 pediatric clinicians revealed that most parents (68%) are open to participating in group well child care (WCC) at their OUD treatment center, indicating a potential for increased engagement in care.

The study identified key barriers to implementing group WCC, such as concerns about privacy and complexity, as well as facilitators like peer support and clinician expertise, which can help shape future implementation strategies for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group Well Child Care for Mothers with Opioid Use Disorder: Framework for Implementation. Goyal, N., Gannon, M., Sood, E., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10692244/

Group Well Child Care for Mothers with Opioid Use Disorder 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 ...

2. link.springer.com link.springer.com/article/10.1007/s10995-023-03762-w

Group Well Child Care for Mothers with Opioid Use Disorder Group well child care (WCC) is an under-studied intervention that may reduce stigma, increase quality of care, and improve clinical outcomes.

3. jdc.jefferson.edu jdc.jefferson.edu/cgi/viewcontent.cgi?article=1138&context=pedsfp

The Child Healthcare at MATER Pediatric Study (CHAMPS) One promising intervention for mothers in treatment for OUD and their children is group WCC, in which mul- tiple mother–child dyads receive ...

4. researchgate.net researchgate.net/publication/372750407_Group_Well_Child_Care_for_Mothers_with_Opioid_Use_Disorder_Framework_for_Implementation

(PDF) Group Well Child Care for Mothers with Opioid Use ... 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 ...

5. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07357-2

a 2-arm cluster randomized control trial of group well child ... 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37515747/

Group Well Child Care for Mothers with Opioid Use Disorder Group well child care (WCC) is an under-studied intervention that may reduce stigma, increase quality of care, and improve clinical outcomes.