NCT07203014

Brief Summary

The goal of this clinical trial is to learn if a new adjunctive intervention, Parent-Educator Action Response (PEAR), works to improve teacher and family engagement in school-based interventions for child attention deficit/hyperactivity disorder (ADHD) and disruptive behavior symptoms. This clinical trial will also be used to refine implementation procedures to inform a larger clinical trial.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Sep 2025Feb 2027

Study Start

First participant enrolled

September 2, 2025

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

November 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1.4 years

First QC Date

September 22, 2025

Last Update Submit

November 3, 2025

Conditions

Keywords

adjunctive interventionPreschool ADHD symptomsDisruptive BehaviorParent-teacher relationshipDaily Report Card

Outcome Measures

Primary Outcomes (1)

  • Daily Report Card Check-In

    The Daily Report Card (DRC) check-in is a weekly survey developed by the investigators that measures daily uptake of DRC usage among parents and teachers across home and school.

    Baseline to 8-week follow-up

Secondary Outcomes (12)

  • Preschool Pediatric Symptom Checklist

    Baseline, 4-week, 8-week follow-ups.

  • Preschool ADHD Rating Scale Version IV (ADHD-RS-IV)

    Baseline, 4-week, 8-week follow-ups.

  • Teacher-Parent Alliance

    Baseline, 4-week, 8-week follow-ups.

  • Teacher-Parent Joining

    Baseline, 4-week, 8-weeks follow-ups.

  • Teacher Self-Efficacy for Classroom Behavior Management

    Baseline, 4-week, 8-week follow-ups.

  • +7 more secondary outcomes

Study Arms (1)

PEAR intervention group

EXPERIMENTAL

All participants will receive the Daily Report Card plus PEAR. PEAR is delivered via group sessions in which participants will be guided through content with a licensed clinical psychologist and will complete activities and receive handouts for reference.

Behavioral: Parent-Educator Action Response (PEAR)Behavioral: Daily Report Card

Interventions

PEAR is a novel adjunctive intervention aimed at improving teacher and family implementation of classroom-based interventions for child ADHD symptoms and disruptive behavior in preschool.

PEAR intervention group

The Daily Report Card is a behavioral intervention for children with challenging behaviors, and provides a structure for teachers and caregivers to support a child with reducing challenging behaviors and increasing positive behaviors. The DRC has been shown to be highly effective in reducing ADHD symptoms.

PEAR intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Teacher or legal guardian/caregiver of a preschool-aged child between 2-5 years old
  • Child has behavioral challenges in the classroom or needs support with social-emotional development
  • Teacher participants must be fluent in English
  • Caregiver participants may be fluent in English or Spanish.

You may not qualify if:

  • Teacher or legal guardian/caregiver of a child who is not 2-5 years old
  • Child does not have behavioral challenges or does not need support with social-emotional development
  • Teacher participants who are not fluent in English
  • Caregiver participants who are not fluent in either English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60614, United States

Location

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior DisordersProblem Behavior

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersBehavioral SymptomsBehaviorChild Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The study uses a pilot roll-out implementation optimization (ROIO) design. A ROIO is a novel methodological innovation that provides a rigorous solution to optimization via iterative, rapid incorporation of partner input throughout implementation in pursuit of effective, affordable, scalable, and efficient outcomes. There will be three clusters over the course of the trial. Each cluster will contain 1-3 early childhood centers. Teachers from each classroom within each center will be recruited and 1-4 families will be recruited from each classroom that has a participating teacher. All participants will receive information on the Daily Report Card followed by the new adjunctive intervention (PEAR). There is no control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Pritzker Department of Psychiatry and Behavioral Health

Study Record Dates

First Submitted

September 22, 2025

First Posted

October 2, 2025

Study Start

September 2, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

November 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations