Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure (INTACT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Percentage of participants that receive a sufficient number of coaching sessions
研究概览
简要总结
The INTACT trial is a multisite pilot feasibility study aimed at testing the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids. The trial will enroll 20 birthing parent/infant dyads across three sites and will evaluate feasibility endpoints rather than clinical outcomes. The study duration is 22 months, including study start-up, enrollment and intervention, and data analysis and manuscript preparation.
详细描述
The INTACT trial is designed to address the need for interventions to improve neurodevelopmental outcomes in infants exposed to cannabinoids in utero. It is a multi-site pilot study conducted across three Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) sites. The trial aims to evaluate the feasibility of the INTACT Intervention program, which focuses on training birthing parents in contingent responding to promote early language, cognitive, and social development in their infants.
The study intervention consists of 12 monthly INTACT intervention coaching sessions, each comprising online module completion followed by personalized coaching sessions with interventionists certified to deliver the Play and Learn Strategies (PALS) methodology, which forms the basis for the INTACT intervention. The online modules focus on strengthening effective parenting practices, while the coaching sessions guide birthing parents in contingent responding techniques, such as reading infant signals and responding with warm and sensitive behaviors. There are three objectives for this study, examining 1) Participant Recruitment, 2) Participant Completion, and 3) Participant Adherence.
Objective 1 examines if birthing parents can be recruited and enrolled in the study. The endpoint of this objective is the percentage of potential participants approached for the study that are consented and determined to be eligible for study participation.
Objective 2 evaluates participant completion, as measured by the percent of birthing parent/infant dyads that complete the coaching session scheduled when the child is 12 months of age.
Objective 3 evaluates the number of individual INTACT intervention coaching sessions completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Birthing Parent
- •Age of majority, as defined by the state of residency
- •Cannabinoid use during pregnancy confirmed with self-report
- •Have the ability to speak, read, and understand English
- •Birthing parent who delivered at one of the hospitals where study team members have clinical privileges to access medical records
- •Has parental custody of the infant
- •Singleton pregnancy with live birth
- •Has an electronic device capable of watching videos and able to stream/download videos for viewing and permitting video conferencing
- •Has study access to the internet
- •Term infants at birth (>37 weeks' gestation)
- •Biological child of the birthing parent
排除标准
- •Birthing Parent
- •Other illicit drug use, excluding cannabinoids, during pregnancy (such as heroin or cocaine) per self-reported or toxicology results
- •Opiate use (prescribed or unprescribed) per self-report or toxicology results during this pregnancy
- •Prolonged hospitalization following delivery longer than 7 days
- •Has major birth defect(s) including physical anomalies including limb malformations/absence of limbs or chromosomal abnormalities
- •Diagnosed with neonatal encephalopathy, metabolic disorder, stroke, intracranial hemorrhage, or meningitis during birth hospitalization
- •Received any major surgical intervention during the birth hospitalization or required a prolonged birth hospitalization (prolonged hospitalization being any hospitalization longer than 7 days)
结局指标
主要结局
Percentage of participants that receive a sufficient number of coaching sessions
时间窗: 12 months following enrollment
Whether a participant will complete the sufficient number of INTACT intervention coaching sessions, defined as completion of at least 8 out of 12 coaching sessions.
Percentage of participants that complete their final visit
时间窗: 12 months following enrollment
Whether a birthing parent/infant dyad will complete the final coaching session when the child is 12 months of age.
Percentage of approached participants that are eligible for study participation
时间窗: 3 months
Whether a potential participant approached for study participation will eventually be consented and determined to be eligible for study participation.
次要结局
未报告次要终点