Viewing Study NCT06241300



Ignite Creation Date: 2024-05-06 @ 8:04 PM
Last Modification Date: 2024-10-26 @ 3:20 PM
Study NCT ID: NCT06241300
Status: RECRUITING
Last Update Posted: 2024-02-05
First Post: 2024-01-17

Brief Title: Executive Function and Parenting in Childhood
Sponsor: University of Illinois at Chicago
Organization: University of Illinois at Chicago

Study Overview

Official Title: Improving Brain-Behavior Markers of Preschool Executive Function Through a Group-Based Parenting Intervention for Low-Income Families
Status: RECRUITING
Status Verified Date: 2024-01
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: EPIC
Brief Summary: Deficits in executive functioning EF disproportionately impact children living in poverty and increase risk for psychopathology particularly disruptive behavior disorders This randomized clinical trial seeks to determine whether childhood EF assessed across neural and behavioral units of analysis is an experimental therapeutic target that can be directly modified through caregiver participation in the Chicago Parent Program CPP if increases in EF predict reduced disruptive behavior trajectories in low-income children over a short-term follow-up period and identify which CPP-driven parenting skill improvements are the most influential in modifying EF This work will contribute new knowledge as to whether a cost-efficient parenting intervention developed for and with low-income families raising young children in poverty can modify EF a neural behavioral mechanism implicated in risk for childhood disruptive behavior problems
Detailed Description: Impairments in executive functioning EF cognitive processes that support self-regulation disproportionately impact children living in poverty and increase vulnerability for childhood disruptive behavior which trigger a cascade of mental health problems and psychosocial difficulties across the lifespan Poverty-related stress and maladaptive parenting styles have been linked to alterations of neural and behavioral EF markers in children despite this no studies have studied if parenting prevention programs can directly target childhood EF and through improving EF reduce disruptive behaviors in at-risk children The National Institute of Mental Health NIMH funded K23 Mentored Patient-Oriented Research Career Development Award project seeks to conduct a mechanistic randomized clinical trial to determine whether neural-behavioral indices of childhood EF is an experimental therapeutic target that can be modified via caregiver participation in the Chicago Parent Program Consistent with the NIMH Research Domain Criteria framework childhood EF will be assessed across brain and behavior measurement units The second aim of the clinical trial seeks to evaluate whether increases in childhood neural-behavioral EF mediate the effects of CPP in reducing disruptive behavior problems over a short-term follow-up A third exploratory aim of the project is to preliminarily test whether increases in specific parenting practices discipline scaffolding previously linked to individual differences in EF mediate the effects of CPP in predicting change in childhood neural-behavioral EF The sample will include 90 Medicaid eligible parent-child ages 4-5 years old dyads and will employ a novel recruitment approach where the target child will have moderate-to-severe EF delays at baseline but does not meet diagnostic criteria for a disruptive behavior disorder

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
K23MH130724-01A1 NIH None httpsreporternihgovquickSearchK23MH130724-01A1