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Trials / Enrolling By Invitation

Enrolling By InvitationNCT07203014

Parent-Educator Action Response

Testing a Brief, Engagement Focused Intervention for Parents and Educators in Preschool: Parent-Educator Action Response

Status
Enrolling By Invitation
Phase
N/A
Study type
Interventional
Enrollment
48 (estimated)
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALParent-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.
BEHAVIORALDaily Report CardThe 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.

Timeline

Start date
2025-09-02
Primary completion
2027-02-01
Completion
2027-02-01
First posted
2025-10-02
Last updated
2025-11-04

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07203014. Inclusion in this directory is not an endorsement.