NCT06241300 Executive Function and Parenting in Childhood
| NCT ID | NCT06241300 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Illinois at Chicago |
| Condition | Disruptive Behavior Disorder, Childhood Onset |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2023-11-20 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2023-11-20 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Children must be between the ages of 4 years old and 5 years, 11 months old * Parent must be the legal guardian of the target child and must live with the child full-time * Parents will be 18 years and older (no maximum age limit) * Only one child and one parent per family can participate in the study * Child is Medicaid eligible, defined as receiving Medicaid or eligible based on family income (up to 142 percent of the federal poverty level) * At enrollment the child will have moderate-to-severe (i.e., (sub)clinical) impairments in executive functioning as indicated by having a global executive composite standardized score greater than or equal to 60 on the Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P), which will be completed by parents at the initial screen * Given that some assessment materials are only validated in English, parents and children for this study will need to be English-speaking * Child does not have a prior or current diagnosis of a disruptive behavior disorder based on Diagnostic Statistical Manual, Fifth Edition (DSM-5) criteria * Child is not currently receiving mental health services * Child does not take medications to treat emotional or behavioral problems * Child does not have a medical condition, such as epilepsy, that would interfere with the completion of study tasks * Child is not actively suicidal * Child does not have a history of psychosis or currently psychotic * Parent does not have a medical condition that would interfere with the completion of the study * Parent does not have an intellectual disability that would interfere with their ability to complete the study * Parent does not have a severe mental illness, active suicidal ideation, or current alcohol/substance abuse/dependence that would interfere with their ability to participate in the study * Child can have a current or past histories of psychiatric disorders (anxiety, mood, attention deficit hyperactivity disorder) * Parent can have current or past history of psychiatric disorders * Parent can be taking medications to treat mental health problems Exclusion Criteria: * Child is not between the ages of 4-5 years old * The parent is not the legal guardian of the target child * The parent does not live with the child full-time * The parent is younger than 18 years old * Child is not receiving Medicaid or Medicaid eligible * Child does not have (sub)clinical impairments in executive functioning as indicated by having a global executive composite standardized score greater than or equal to 60 on the BRIEF * Child and parent are not English-Speaking * Child has a prior or current diagnosis of a disruptive behavior disorder based on DSM-5 criteria * Child is currently receiving mental health services * Child currently takes medications to treat emotional or behavioral problems * Child has a medical condition, such as epilepsy, that would interfere with the completion of study tasks * Child is actively suicidal * Child has a history of psychosis or is currently psychotic * Parent is not willing to be randomly assigned to receive the Chicago Parent Program intervention or to the control condition where they will not receive an intervention * Parent has a medical condition that would interfere with the completion of the study * Parent has an intellectual disability that would interfere with their ability to complete the study * Parent has a severe mental illness and/or active suicidal ideation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06241300 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, studying Disruptive Behavior Disorder, Childhood Onset. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06241300 currently recruiting?
Yes, NCT06241300 is actively recruiting participants. Contact the research team at jesuor@uic.edu for enrollment information.
Where is the NCT06241300 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06241300 clinical trial?
NCT06241300 is sponsored by University of Illinois at Chicago. The trial plans to enroll 180 participants.