Child Healthcare at MATER - Pediatric Study

NCT ID: NCT05488379

Last Updated: 2022-08-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2025-10-31

Brief 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.

Detailed 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.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Individual well child care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group well child care

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

Group Type: EXPERIMENTAL

Group well child care

Intervention Type: OTHER

Beginning with the 1-month well child care visit, mother-infant dyads will participate in well child care together, with subsequent visits occurring at the American Academy of Pediatrics recommended intervals (2, 4, 6, 9, 12, 15, and 18 months of age).

Interventions

Group well child care

Beginning with the 1-month well child care visit, mother-infant dyads will participate in well child care together, with subsequent visits occurring at the American Academy of Pediatrics recommended intervals (2, 4, 6, 9, 12, 15, and 18 months of age).

Intervention Type: OTHER

Other Intervention Names

CenteringParenting

Eligibility Criteria

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 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Alfred I. duPont Hospital for Children

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vanessa Short, PhD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Neera Goyal, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Al DuPont Pediatrics

Locations

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hannah Steiger, PhD

Role: CONTACT

Hannah.Steiger@jefferson.edu

267-949-6592

Facility Contacts

Hannah Steiger

Role: primary

References

Short VL, Abatemarco DJ, Sood E, Hand DJ, Gannon M, Hossain J, Goyal NK. 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. Trials. 2023 May 17;24(1):333. doi: 10.1186/s13063-023-07357-2.

Reference Type: DERIVED

PMID: 37194074 (View on PubMed)

Other Identifiers

17540

Identifier Type: -

Identifier Source: org_study_id