Child Healthcare at MATER - Pediatric Study

Opioid Use Disorder Clinical Trial

— CHAMPS  

Official title:

Well Child Care Intervention for Infants of Mothers in Treatment for Opioid Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05488379
• Other study ID #: 17540
• Status: Recruiting
• Phase: N/A
• Start date: December 31, 2021
• Est. completion date: October 2025

Study information

• Verified date: August 2022
• Source: Thomas Jefferson University
• Contact: Hannah Steiger, PhD
• Phone: 267-949-6592
• Email: Hannah.Steiger[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: October 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Other:
• 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).

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Thomas Jefferson University	Agency for Healthcare Research and Quality (AHRQ), Alfred I. duPont Hospital for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Infant healthcare utilization	lead screening; up-to-date immunization status based on the CDC immunization schedule; maternal depression screening; PEDS developmental screening; infant Hepatitis C screening among those with perinatal Hepatitis C exposure; number of acute primary care visits (sick visits); emergency department utilization and hospitalization; subspecialist referrals and visits; early intervention referral and enrollment.	18 months of age
Secondary	Infant development	self reported using Ages & Stages Questionnaires, 3rd Edition (ASQ-3), a set of 40-item parent-reported age-specific development screening questions assessing communication, gross motor, fine motor, problem solving and personal-social skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.	6 months of age
Secondary	Infant development	self reported using Ages & Stages Questionnaires, 3rd Edition (ASQ-3), a set of 40-item parent-reported age-specific development screening questions assessing communication, gross motor, fine motor, problem solving and personal-social skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.	12 months of age
Secondary	Infant development	self reported using Ages & Stages Questionnaires, 3rd Edition (ASQ-3), a set of 40-item parent-reported age-specific development screening questions assessing communication, gross motor, fine motor, problem solving and personal-social skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.	18 months of age
Secondary	Maternal health behaviors	self-reported duration of breastfeeding, infant sleep positioning, contraception use , and repeat pregnancy.	12 months of age
Secondary	Maternal psychosocial	depression using the Edinburgh Postnatal Depression Scale; The EPDS is a 10-item self report used to measure postpartum depression. Scores range from 0-30, with a higher score indicating a greater severity of depression.	18 months of age
Secondary	Maternal psychosocial	General stress using the Perceived Stress Scale (PSS; higher scores indicate higher stress); The Perceived Stress Scale (PSS) is a 10-item scale to measure stress. Scores range from 0-40, with higher scores indicating greater perceived stress.	18 months of age
Secondary	Maternal psychosocial	Parenting stress using the Parenting Stress Index (PSI); The Parenting Stress Index (PSI) is a 36-item questionnaire assessing parental stress. Total scores range from 36 to 180, with higher scores indicating greater parental stress.	18 months of age
Secondary	Maternal psychosocial	Social support using the Social Provisions Scale (SPS); The Social Provisions Scale (SPS) is one of the most frequently used scales on social support, and is validated to measure the components of social support that directly impact health outcomes: attachment, social integration, reassurance of worth, reliable alliance, guidance, and opportunity for nurturance.	18 months of age
Secondary	Maternal return to illicit substance abuse	Any number of positive urine drug screens for illicit substance(s)	18 months of age
Secondary	Maternal sensitivity/responsiveness	Self-reported using the Maternal Responsiveness Questionnaire, which measures the extent to which mothers respond promptly to their infants across different situations. The measure yields 3 subscales: responsiveness, non-responsiveness, and delayed responsiveness. Higher scores indicate higher tendency for responsiveness, non-responsiveness, and delayed responsiveness.	12 months of age
Secondary	Maternal sensitivity/responsiveness	Self-reported using the Coping with Toddlers' Negative Emotions Scale (CTNES) which measures the degree to which mother perceive themselves as reactive to their children's negative affect in distressful situations.; The CTNES consists of scenarios in which youth may experience negative emotion. Parents are asked to identify how they would respond to each scenario. Each scenario has six responses which parents rate on a 7 point Likert-scale regarding their likelihood of responding that way (1 = very unlikely, 7 = very likely). This measure has six subscales which include emotion focused, problem-focused, minimization, punitive, expressive encouragement, and distress responses. Higher scores indicate a higher presence of that parenting response.	18 months of age