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Parent-Educator Action Response (PEAR)

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

Ann & Robert H Lurie Children's Hospital of Chicago

Status

Invitation-only

Conditions

Attention Deficit and Disruptive Behavior Disorders

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT07203014
K23MH129575 (U.S. NIH Grant/Contract)
STUDY00000176

Details and patient eligibility

About

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.

Full description

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.

Enrollment

48 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

PEAR intervention group
Experimental group
Description:
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.
Treatment:
Behavioral: Parent-Educator Action Response (PEAR)
Behavioral: Daily Report Card

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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