Executive Function and Parenting in Childhood (NCT06241300) | Clinical Trial Compass
RecruitingNot Applicable
Executive Function and Parenting in Childhood
United States180 participantsStarted 2023-11-20
Plain-language 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.
Who can participate
Age range
4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 medi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)