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Executive Function Curriculum for Executive Dysfunction

N/A
Waitlist Available
Led By Lauren Kenworthy
Research Sponsored by Children's National Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronological age between 3-6 years at enrollment
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, average of 20 weeks
Awards & highlights

Study Summary

This trial will aim to improve children's educational trajectories by targeting executive function skills in preschoolers with poor executive function. This project will address a key source of the achievement gap by meeting the needs of children at the highest risk.

Who is the study for?
This trial is for preschool children aged 3-6 who show early signs of executive function impairment, live in low-income communities, or are at risk for developmental and emotional disabilities. They must have roughly age-appropriate language skills, be enrolled at a participating school or clinic site, and primarily speak English.Check my eligibility
What is being tested?
The 'Unstuck and On Target: Preschool' curriculum is being tested to improve executive function (EF) skills in preschoolers with poor EF. The study will refine the intervention using feedback from participants, teachers, and parents to prepare for a larger future trial.See study design
What are the potential side effects?
Since this intervention involves educational activities rather than medical treatments, traditional side effects are not applicable. However, there may be variations in individual responses to the curriculum based on each child's unique learning needs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 3 and 6 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, average of 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, average of 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of Intervention
Feasibility - Child Attendance
Feasibility of Intervention
+1 more
Secondary outcome measures
Fidelity Observations
Interventionist Knowledge
Other outcome measures
Behavior Rating Inventory of Executive Functioning-Preschool (BRIEF-P): Selected subscales
Child Behavior Rating Scale (CBRS)
Classroom Observations
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Unstuck and On Target-PreschoolExperimental Treatment1 Intervention
UOT-P is based on the foundational principles of UOT for improving EF as well as evidence-based teaching methods (e.g., positive behavior supports, visual aids). Through this program, children, teachers and parents develop a shared self-regulatory vocabulary that enables children to improve EF at home and school through adult modeling and gradual scaffolding. The self-regulatory vocabulary (e.g., Flexible, Make a New Plan, Unstuck) becomes a "contagious" common language. We hypothesize this is the mechanism of change by which children will show improved EF skills, leading to increased academic readiness, improved social competence and reduced externalizing behaviors.
Group II: Waitlist ControlActive Control1 Intervention
Children at clinic sites beginning in Year 4 will be placed in Arm 2, in which a waitlist control model will be used. Assessment of participants on outcome measures will occur at pre-intervention, followed by a 16-week waitlist period, again at baseline, followed by a 16-week intervention, and then finally at endpoint. All participants in Arm 2 will receive UOT-P as their intervention (see Experimental Arm).

Find a Location

Who is running the clinical trial?

The Maddux SchoolUNKNOWN
AppleTree InstituteUNKNOWN
Children's National Research InstituteLead Sponsor
214 Previous Clinical Trials
209,232 Total Patients Enrolled
2 Trials studying Executive Dysfunction
288 Patients Enrolled for Executive Dysfunction

Media Library

Unstuck and On Target: Preschool Clinical Trial Eligibility Overview. Trial Name: NCT05135728 — N/A
Executive Dysfunction Research Study Groups: Waitlist Control, Unstuck and On Target-Preschool
Executive Dysfunction Clinical Trial 2023: Unstuck and On Target: Preschool Highlights & Side Effects. Trial Name: NCT05135728 — N/A
Unstuck and On Target: Preschool 2023 Treatment Timeline for Medical Study. Trial Name: NCT05135728 — N/A
Executive Dysfunction Patient Testimony for trial: Trial Name: NCT05135728 — N/A
~24 spots leftby Jun 2026
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