Clinical trial NCT05488379: Child Healthcare at MATER - Pediatric Study
Official title: Well Child Care Intervention for Infants of Mothers in Treatment for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Group well child care
Child developement
Parenting behavior
Healthcare quality
Healthcare experience
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Alfred I. duPont Hospital for Children
First posted: 2022-08-04
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Well child care engagement
timeFrame: 18 months post-delivery
measure: Parenting Knowledge
timeFrame: 18 months post-delivery
measure: Maternal-child interaction quality
timeFrame: 18 months post-delivery
Secondary outcomes:
measure: Infant healthcare utilization
timeFrame: 18 months of age
measure: Infant development
timeFrame: 6 months of age
measure: Infant development
timeFrame: 12 months of age
measure: Infant development
timeFrame: 18 months of age
measure: Maternal health behaviors
timeFrame: 12 months of age
measure: Maternal psychosocial
timeFrame: 18 months of age
measure: Maternal psychosocial
timeFrame: 18 months of age
measure: Maternal psychosocial
timeFrame: 18 months of age
measure: Maternal psychosocial
timeFrame: 18 months of age
measure: Maternal return to illicit substance abuse
timeFrame: 18 months of age
measure: Maternal sensitivity/responsiveness
timeFrame: 12 months of age
measure: Maternal sensitivity/responsiveness
timeFrame: 18 months of age
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Vanessa Short, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nemours Al DuPont Pediatrics
name: Neera Goyal, MD
role: PRINCIPAL_INVESTIGATOR
References: