Executive Function and Parenting in Childhood

NCT06241300 | Recruiting DMC

• 2 other identifiers: 2023-0048K23MH130724-01A1
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Disruptive Behavior Disorder, Childhood Onset; Disruptive Behavior; Executive Function

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  an average of 4 months

Secondary Outcomes (3)

• Child Behavior Checklist (CBCL, 1.5-5)

  through study completion, an average of 16 months

• Eyberg Child Behavior Inventory (ECBI)

  through study completion, an average of 16 months

• Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)-COMPUTER (COMP)

  through study completion, an average of 16 months

Other Outcomes (4)

• Home EF Environment (HEFE)

  an average of 4 months

• Parenting Dimensions Inventory (PDI)

  an average of 4 months

• Parenting Questionnaire (PQ)

  an average of 4 months

Study Arms (2)

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.

Behavioral: Chicago Parent Program

Control Condition

NO INTERVENTION

Half of the dyads will be randomized to the no intervention arm.

Interventions

Chicago Parent Program BEHAVIORAL

Chicago Parent Program is an evidence-based group parenting intervention designed to reduce disruptive behavior in young children (2-8 years old).

Chicago Parent Program

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Mental Health (NIMH): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Illinois-Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders; Problem Behavior

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Central Study Contacts

Jennifer Suor, PhD

CONTACT

7733208989; jesuor@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors of executive function, disruptive behavior, and parenting outcomes will be blind to which condition participants were randomized to.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 5, 2024
• Study Start: November 20, 2023
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)