Disruptive Behavior Disorder, Childhood OnsetEPICNCT06241300
Executive Function and Parenting in Childhood
A study testing Chicago Parent Program in people with Disruptive Behavior Disorder, Childhood Onset and Disruptive Behavior, run by University of Illinois at Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Disruptive Behavior Disorder, Childhood Onset, Disruptive Behavior, Executive Function
- What is being tested?
- Chicago Parent Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois-Chicago
Chicago, Illinois, 60612
Jennifer Suor, PhD, 7733208989, jesuor@uic.edu
Jennifer Suor, PhD
About this study
Official title: Improving Brain-Behavior Markers of Preschool Executive Function Through a Group-Based Parenting Intervention for Low-Income Families
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.
Read the 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.
- Being tested
- Chicago Parent Program
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chicago Parent ProgramBehavioural
Chicago Parent Program is an evidence-based group parenting intervention designed to reduce disruptive behavior in young children (2-8 years old).
| Study group | Role | What they receive |
|---|---|---|
| Chicago Parent Program | Experimental | Half of the dyads will be randomized to participant in the Chicago Parent Program (CPP), an evidence-based parenting preventive intervention for urban poor parents with children between the ages of 2-8 with behavior problems. The Chicago Parent Program consists of 12 groups sessions (11 weekly, 1 booster session). The groups are co-facilitated by two certified group leaders. Parents learn positive parenting and effective child behavior management skills, strategies to support the child's attention, literacy, and social skills, and stress management and problem solving techniques. Skill building is accomplished through watching videos of real-life parents and children during parent-child interactions, group discussion, role-playing, and weekly homework assignments. Receives: Behavioral: Chicago Parent Program |
| Control Condition | No intervention | Half of the dyads will be randomized to the no intervention arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)
Parents will complete the BRIEF-P to assess their child's executive functioning, and the Global Executive Composite score will be used in the analysis.
Measured: an average of 4 months
NIH Toolbox Early Childhood Cognitive Battery
Children will be administered the NIH Toolbox Early Childhood Cognitive Battery to assess their executive functioning.
Measured: an average of 4 months
EEG-Based indices of EF
Children will complete the Zoo Go/No-Go computerized task while EEG is simultaneously recorded. Event-related potential components that index EF and theta spectral power and error-related interchannel phase frequency between frontocentral and frontolateral regions, will be used in the analyses.
Measured: an average of 4 months
Secondary outcomes (3)
Child Behavior Checklist (CBCL, 1.5-5)
Parents will complete the Child Behavior Checklist in order to assess children's disruptive behavior symptoms.
Measured: through study completion, an average of 16 months
Eyberg Child Behavior Inventory (ECBI)
Parents will complete the Eyberg Child Behavior Inventory in order to assess children's disruptive behavior problems.
Measured: through study completion, an average of 16 months
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)-COMPUTER (COMP)
Parents will be administered the clinician administered the K-SADS-COMP, which is a web-based semi-structured interview to assess children's disruptive behavior symptoms and to determine if children meet criteria for a disruptive behavior disorder.
Measured: through study completion, an average of 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start20 Nov 2023
- Primary completion28 Feb 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive Behavior Disorder, Childhood OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Chicago Parent Program (developer Dr. Deborah Gross) is an evidence-based parenting preventive intervention for urban poor parents with children between the ages of 2-8 years old with behavior problems. The study will include 90 children at risk for disruptive behavior disorders based on demonstrating moderate-to-severe impairments in EF established at the initial screen via parent report on the Behavior Rating Inventory of Executive Function-Preschool Version. Half of the dyads (n = 45) will be randomly assigned to receive the Chicago Parent Program and half (n = 45) will receive no intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241300
- Sponsor's protocol ID
- 2023-0048
- Other IDs
- K23MH130724-01A1
- Acronym
- EPIC
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Brain-Behavior Markers of Preschool Executive Function Through a Group-Based Parenting Intervention for Low-Income Families
- ClinicalTrials.gov ID
- NCT06241300
- Acronym / sponsor ID
- EPIC / 2023-0048
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institutes of Health (NIH)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The Chicago Parent Program (developer Dr. Deborah Gross) is an evidence-based parenting preventive intervention for urban poor parents with children between the ages of 2-8 years old with behavior problems. The study will include 90 children at risk for disruptive behavior disorders based on demonstrating moderate-to-severe impairments in EF established at the initial screen via parent report on the Behavior Rating Inventory of Executive Function-Preschool Version. Half of the dyads (n = 45) will be randomly assigned to receive the Chicago Parent Program and half (n = 45) will receive no intervention.
| Arm | Type | Receives |
|---|---|---|
| Chicago Parent Program | Experimental | Behavioral: Chicago Parent ProgramHalf of the dyads will be randomized to participant in the Chicago Parent Program (CPP), an evidence-based parenting preventive intervention for urban poor parents with children between the ages of 2-8 with behavior problems. The Chicago Parent Program consists of 12 groups sessions (11 weekly, 1 booster session). The groups are co-facilitated by two certified group leaders. Parents learn positive parenting and effective child behavior management skills, strategies to support the child's attention, literacy, and social skills, and stress management and problem solving techniques. Skill building is accomplished through watching videos of real-life parents and children during parent-child interactions, group discussion, role-playing, and weekly homework assignments. |
| Control Condition | No intervention | –Half of the dyads will be randomized to the no intervention arm. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chicago Parent ProgramChicago Parent Program is an evidence-based group parenting intervention designed to reduce disruptive behavior in young children (2-8 years old). | Behavioural | Chicago Parent Program |
Primary outcome
Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P)
Time frame: an average of 4 months
Parents will complete the BRIEF-P to assess their child's executive functioning, and the Global Executive Composite score will be used in the analysis.
NIH Toolbox Early Childhood Cognitive Battery
Time frame: an average of 4 months
Children will be administered the NIH Toolbox Early Childhood Cognitive Battery to assess their executive functioning.
EEG-Based indices of EF
Time frame: an average of 4 months
Children will complete the Zoo Go/No-Go computerized task while EEG is simultaneously recorded. Event-related potential components that index EF and theta spectral power and error-related interchannel phase frequency between frontocentral and frontolateral regions, will be used in the analyses.
3 secondary outcomes
Child Behavior Checklist (CBCL, 1.5-5)
Time frame: through study completion, an average of 16 months
Eyberg Child Behavior Inventory (ECBI)
Time frame: through study completion, an average of 16 months
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)-COMPUTER (COMP)
Time frame: through study completion, an average of 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chicago Parent Program in people with Disruptive Behavior Disorder, Childhood Onset and Disruptive Behavior, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Suor, PhD (7733208989, jesuor@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) (time frame: an average of 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.