Child Healthcare at MATER - Pediatric Study

Last updated: August 2, 2022
Sponsor: Thomas Jefferson University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Treatment

N/A

Clinical Study ID

NCT05488379
17540
  • Ages > 18
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion

Exclusion Criteria:

  • 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 unlessthe mother or infant experiences the following: gestational age at time of delivery lessthan or equal to 32 weeks or illness or clinical complication warranting prolongedhospitalization after delivery.

Study Design

Total Participants: 108
Study Start date:
December 31, 2021
Estimated Completion Date:
October 31, 2025

Study Description

This is a single-site cluster randomized controlled trial. Over an 18-month period, 108 pregnant women receiving treatment for opioid use disorder will be identified, screened, and enrolled into the study. Beginning with the birthdate of the first infant born in the study, 18 consecutive 1-month birth intervals will be randomized in a 1:1 ratio to one of two study arms: (1) group well child care or (2) individual well child care. Nine birth clusters will be randomized to individual well child care(control arm) and nine birth clusters will be randomized to group well child care(intervention arm), with concealment of randomization from enrolled participants until they give birth. All study participants will be included in the study until their child is approximately 18 months of age. All study participants will have a total of 5 assessment visits with research personnel; visits will occur immediately following enrollment into the study (baseline), prior to the participant's child turning 1 month of age, and within 4 weeks of the participant's child turning 6, 12, and 18 months of age. The efficacy of group well child care to improve health and healthcare-related outcomes will be evaluated.

Connect with a study center

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19106
    United States

    Active - Recruiting

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