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

108 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this project is to implement and evaluate a group model of well child care for mothers in treatment for opioid use disorder and their children that addresses the specific health needs and concerns of opioid-exposed infants, is trauma informed, and is embedded within a maternal opioid use disorder treatment program. 108 mother-infant dyads will be randomized 1:1 to group well child care or individual well child care, and followed over an 18 month period. Qualitative and quantitative data will be collected at multiple time points. The efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.

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 data supports the effectiveness of the treatment Group Well Child Care for Mothers with Opioid Use Disorder?

Group well child care, where families receive pediatric care together, has been shown to increase patient satisfaction and adherence to recommended care in general. However, specific evidence for its effectiveness in mothers with opioid use disorder is still lacking. ^{1 2 3 4 5}

Is group well child care safe for mothers with opioid use disorder?

The research does not provide specific safety data for group well child care for mothers with opioid use disorder, but similar group care models, like group prenatal care, have been well-received and show promise in improving satisfaction and engagement with healthcare. ^{1 3 4 5 6}

How is the group well child care treatment different for mothers with opioid use disorder?

Group well child care is unique because it brings families together in a shared medical appointment, which can reduce stigma and improve satisfaction and adherence to care. This approach is particularly beneficial for mothers with opioid use disorder, as it integrates maternal and child healthcare, potentially improving outcomes for both mothers and their children. ^{2 3 4 5 6}

Research Team

Neera Goyal, MD

Principal Investigator

Nemours Al DuPont Pediatrics

Vanessa Short, PhD

Principal Investigator

Thomas Jefferson University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Perceptions of Pediatric Primary Care Among Mothers in Treatment for Opioid Use Disorder. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Group Well Child Care for Mothers with Opioid Use Disorder: Framework for Implementation. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Priorities for Well Child Care of Families Affected by Parental Opioid Use Disorder. [2023]

4. England 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. [2023]

5. United States 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Group Prenatal Care for Women Receiving Medication-Assisted Treatment for Opioid Use Disorder in Pregnancy: An Interprofessional Approach. [2020]