Well Child Care Intervention for Infants of Mothers in Treatment for Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Well child care engagement
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Well child care engagement
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Infant healthcare utilization(18 months of age)
- Maternal health behaviors(12 months of age)
- Maternal psychosocial(18 months of age)
- Infant development(18 months of age)
- Maternal return to illicit substance abuse(18 months of age)
- Maternal sensitivity/responsiveness(18 months of age)