Child Healthcare at MATER - Pediatric Study

Completed · Not applicable

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT05488379

Run by

Thomas Jefferson University

People needed

49

Starts

2021-12-31

Expected to finish

2026-01-29

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• at least 28 weeks pregnant or less than 2 weeks postpartum
• receiving treatment for opioid use disorder
• ability to read and speak English
• plans to parent infant after delivery
• intent to seek pediatric care within Nemours/Thomas Jefferson University system
• intent to remain in the Philadelphia area for the next 2 years

You may not qualify if…

• inability to speak English
• plans to move outside of the Philadelphia area in the next 2 years
• plans to not parent infant after delivery
• plans to seek pediatric care outside of the Nemours/Thomas Jefferson University System
• Following a live birth, participants will remain eligible to continue in the study unless the mother or infant experiences the following: gestational age at time of delivery less than or equal to 32 weeks or illness or clinical complication warranting prolonged hospitalization after delivery.

Where it is running

• Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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