Parent-Educator Action Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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School-based behavioral interventions are well-established treatments for preschool children who display elevated ADHD symptoms, regardless of a diagnosis, and are the recommended first line of treatment according to the American Academy of Pediatrics. However, teachers and families face barriers to implementing behavioral interventions with the recommended frequency and fidelity. The investigators are proposing to test a new adjunctive intervention that is aimed at improving teacher and family implementation of school-based interventions for preschool disruptive behavior and ADHD symptoms. The investigators will be testing PEAR plus a school-based intervention (Daily Report Card; DRC) in a pilot roll-out implementation optimization (ROIO) trial with three clusters (groups of schools) across two years.

Adjunctive Intervention (PEAR). All participating parents and teachers will complete PEAR. PEAR consists of three group sessions (one for caregivers and one for educators) followed by a meeting with each caregiver-educator dyad.

Daily Report Card. The primary goal of PEAR is to improve teacher and family implementation of an evidence-based practice for ADHD symptoms in preschool. The investigators have decided to focus on implementation of the Daily Report Card. Following consent, teachers will receive handouts on the Daily Report Card and will be asked to implement it for the child whose parents are in PEAR. Teachers and parents will be asked to complete weekly reports measuring teacher and family daily use of the DRC starting at BL through the 4-week follow up (8 weeks total).

Assessment Procedures. Assessments will be completed at three time points: BL (week 0), post-PEAR (4 weeks from BL), and follow-up (8 weeks from BL). At each assessment, participating legal guardians and teachers will complete rating scales electronically via RedCap, a scalable, secure, enterprise-level application for data collection. Interviews: Qualitative interviews with parents and teachers who participate in PEAR will be conducted to understand their experiences and identify potential areas for improvement.

Analytic Approach. This clinical trial will specifically examine the acceptability, feasibility and promise of PEAR and refine and optimize trial procedures. Basic data screening and descriptive analyses will be conducted for all variables, and the investigators will screen for errors, distributional form, and missing data. For all models, the investigators will check assumptions to ensure that results are not an artifact of violations. Below are analytic details for each aim of the trial:

Is PEAR and the implementation strategies acceptable and feasible? Overall, PEAR acceptability and feasibility for all participants will be evaluated by examining the mean parent and teacher ratings of satisfaction, acceptability, appropriateness, and feasibility. Consumer fit will be considered acceptable if scores are above the neutral point of the scale for all measures except fidelity, which the investigators will consider 80% as the target point. The investigators will also examine whether acceptability and feasibility indices vary by classroom and participant demographics by treating these predictors as fixed effects in regression analyses.

Are the ROIO trial procedures acceptable and feasible? This aim is focused on (a) refining recruitment procedures and study protocol to obtain an adequate sample of parents, (b) optimizing screening and assessment procedures in preschool, and (c) optimizing procedures for sustaining participants in PEAR (i.e., minimizing drop-out).

Does PEAR improve teacher and family fidelity to the Daily Report Card? The investigators will collect daily (weekdays only) counts of family and teacher implementation of the Daily Report Card starting at BL through follow-up (8 weeks total). Fidelity will be defined as the proportion of weekdays the Daily Report Card is implemented at home, school, and both. The investigators are interested in examining the change in fidelity across time. Hierarchical multi-level models will be used to ensure inclusion of random effects, variations between clusters, variation between times within cluster, and fixed effects of time which will be estimated independently of treatment effect, so that systematic change over time will not be mistaken for the effect of treatment.

Conditions

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Attention Deficit and Disruptive Behavior Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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PEAR intervention group

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.

Group Type EXPERIMENTAL

Daily Report Card

Intervention Type BEHAVIORAL

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.

Parent-Educator Action Response (PEAR)

Intervention Type BEHAVIORAL

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.

Interventions

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Daily Report Card

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.

Intervention Type BEHAVIORAL

Parent-Educator Action Response (PEAR)

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Eligible Sex

ALL

Accepts Healthy Volunteers

No