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Group Well Child Care for Mothers with Opioid Use Disorder (CHAMPS Trial)

N/A

Recruiting

Led By Neera Goyal, MD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months of age

Awards & highlights

CHAMPS Trial Summary

This trial will compare group well child care to individual well child care for mothers in treatment for opioid use disorder, to see if it improves health outcomes for mother and child.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves models of childcare rather than medication, there aren't typical medical side effects. However, participants may experience differences in satisfaction or stress levels based on the type of childcare received.

CHAMPS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months of age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months of age

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maternal-child interaction quality

Parenting Knowledge

Well child care engagement

Secondary outcome measures

Infant development

Infant healthcare utilization

Maternal health behaviors

+3 more

CHAMPS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group well child careExperimental Treatment1 Intervention

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

Group II: Individual well child careActive Control1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,381 Total Patients Enrolled

Agency for Healthcare Research and Quality (AHRQ)FED

399 Previous Clinical Trials

6,822,240 Total Patients Enrolled

Alfred I. duPont Hospital for ChildrenOTHER

23 Previous Clinical Trials

5,020,803 Total Patients Enrolled

Media Library

Group well child care Clinical Trial Eligibility Overview. Trial Name: NCT05488379 — N/A

Opioid Use Disorder Research Study Groups: Individual well child care, Group well child care

Opioid Use Disorder Clinical Trial 2023: Group well child care Highlights & Side Effects. Trial Name: NCT05488379 — N/A

Group well child care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488379 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in the experiment at maximum capacity?

"Affirmative, the clinical trial is in need of volunteers. According to records on clinicaltrials.gov, this study was initially posted on December 31st 2021 and edited as recently as August 2nd 2022. The medical research requires 108 participants from just 1 site location."

Answered by AI

Is recruitment still in progress for this research endeavor?

"According to data hosted on clinicaltrials.gov, this research is actively seeking participants since it was first posted in December 2021 and most recently updated in August 2022."

Answered by AI

What are the desired outcomes of this experiment?

"Over 18 months post-delivery, this clinical trial aspires to increase the quality of well child care. Secondary objectives include tracking maternal health behaviours such as duration of breastfeeding, infant sleep positioning and contraception use, determining if mothers go back to illicit substance abuse through urine drug screens and assessing infant development by employing Ages & Stages Questionnaires (ASQ-3), a 40-item parent questionnaire evaluating communication skills, gross motor aptitude, fine motor capability , problem solving proficiency and personal-social awareness. Results are scored between 0 - 60 with higher scores suggesting typical growth for infants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Child Healthcare at MATER - Pediatric Study

2021. "Child Healthcare at MATER - Pediatric Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05488379.

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