Child Healthcare at MATER - Pediatric Study

NCT05488379 | Completed

• 1 other identifier: 17540
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder

Keywords

Group well child care; Child developement; Parenting behavior; Healthcare quality; Healthcare experience

Outcome Measures

Primary Outcomes (3)

• Well child care engagement

  Measured as both utilization and experience of well child care. Utilization will be defined as total number of well child care visits during the child's first 18 months of life. Adequacy of well child care during this time period will be dichotomized as adequate (7 well child care visits) or inadequate (\<7 well child care visits). This definition is adapted from the Health Plan Employer Data and Information Set (HEDIS) measure for well child care. The Promoting Healthy Development Survey (PHDS) will be used to evaluate participants' perceptions of their child's well child care, including anticipatory guidance, developmental surveillance, family-centeredness, family risk assessment, and helpfulness of care.

  18 months post-delivery

• Parenting Knowledge

  A survey instrument will include investigator-developed questions as well as questions from the Knowledge of Infant Development Inventory (KIDI).

  18 months post-delivery

• Maternal-child interaction quality

  This will be directly assessed using a video recorded mother/child free play at 18 months. Interactions will be coded by using the Keys to Interactive Parenting Scale (KIPS). KIPS is a structured observational measure and assesses 12 domains of parenting. The domains are scored on a 1 to 5-point scale with higher scores indicating higher quality parenting behaviors.

  18 months post-delivery

Secondary Outcomes (12)

• Infant healthcare utilization

  18 months of age

• Infant development

  6 months of age

• Infant development

  12 months of age

• Infant development

  18 months of age

• Maternal health behaviors

  12 months of age

Study Arms (2)

Individual well child care

NO INTERVENTION

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

Group well child care

EXPERIMENTAL

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

Other: Group well child care

Interventions

Group well child care 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).

Also known as: CenteringParenting

Group well child care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Alfred I. duPont Hospital for Children: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19106, United States

Location

Related Publications (1)

• 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.

  PMID: 37194074 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Vanessa Short, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

• Neera Goyal, MD

  Nemours Al DuPont Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: August 4, 2022
• Study Start: December 31, 2021
• Primary Completion: January 29, 2026
• Study Completion: January 29, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)