Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423664
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-05-16
Brief Title:
Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure
Sponsor:
IDeA States Pediatric Clinical Trials Network
Organization:
IDeA States Pediatric Clinical Trials Network
Study Overview
Official Title:
Pilot Feasibility Trial of Improving Neurodevelopmental ouTcomes After Prenatal Cannabinoid in uTero Exposure INTACT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTACT
Brief Summary:
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 parentinfant 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
Detailed Description:
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 parentinfant 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
The study duration is planned for 22 months including 1-4 months for study development and start-up 3 months for enrollment 12 months for the intervention and 3 months for data organization clean-up and manuscript preparation
The INTACT trial will not assess clinical outcomes but will inform the design of a future larger-scale clinical trial to evaluate the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids
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 parentinfant 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
The study duration is planned for 22 months including 1-4 months for study development and start-up 3 months for enrollment 12 months for the intervention and 3 months for data organization clean-up and manuscript preparation
The INTACT trial will not assess clinical outcomes but will inform the design of a future larger-scale clinical trial to evaluate the effectiveness of the INTACT Intervention program in improving neurodevelopmental outcomes in infants prenatally exposed to cannabinoids
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U24OD024957 | NIH | None | httpsreporternihgovquickSearchU24OD024957 |