Opioid Use Disorder
Conditions
Keywords
Group well child care, Child developement, Parenting behavior, Healthcare quality, Healthcare experience
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.
Interventions
OTHERGroup 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).
Sponsors
Thomas Jefferson University
Agency for Healthcare Research and Quality (AHRQ)
Alfred I. duPont Hospital for Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Well child care engagement | 18 months post-delivery | 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. |
| Parenting Knowledge | 18 months post-delivery | A survey instrument will include investigator-developed questions as well as questions from the Knowledge of Infant Development Inventory (KIDI). |
| Maternal-child interaction quality | 18 months post-delivery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant healthcare utilization | 18 months of age | 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. |
| Infant development | 6 months of age | 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. |
| Maternal health behaviors | 12 months of age | self-reported duration of breastfeeding, infant sleep positioning, contraception use , and repeat pregnancy. |
| Maternal psychosocial | 18 months of age | 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. |
| Maternal return to illicit substance abuse | 18 months of age | Any number of positive urine drug screens for illicit substance(s) |
| Maternal sensitivity/responsiveness | 12 months of age | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORVanessa Short, PhD
Thomas Jefferson University
PRINCIPAL_INVESTIGATORNeera Goyal, MD
Nemours Al DuPont Pediatrics
Outcome results
None listed