RECRUITING

Executive Function and Parenting in Childhood

Conditions

Disruptive Behavior Disorder, Childhood Onset Disruptive Behavior Executive Function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Improving Brain-Behavior Markers of Preschool Executive Function Through a Group-Based Parenting Intervention for Low-Income Families

Quick Facts

Study Start:2023-11-20

Study Completion:2028-03-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06241300

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jennifer Suor, PhD

CONTACT

7733208989

jesuor@uic.edu

Study Locations (Sites)

University of Illinois-Chicago

Chicago, Illinois, 60612

United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-20

Study Completion Date2028-03-31

Study Record Updates

Study Start Date2023-11-20

Study Completion Date2028-03-31

Terms related to this study

Additional Relevant MeSH Terms

Disruptive Behavior Disorder, Childhood Onset
Disruptive Behavior
Executive Function