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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

No Placebo-Only Group

Summary

This trial aims to help preschoolers with poor thinking and behavior skills by using a special program called UOT-P. The program focuses on improving their ability to think flexibly, control their actions, and manage emotions. It targets children in low-income areas who are at risk for developmental issues.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, average of 20 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of Intervention

Feasibility - Child Attendance

Feasibility of Intervention

+1 more

Secondary study objectives

Fidelity Observations

Interventionist Knowledge

Other study objectives

Behavior Rating Inventory of Executive Functioning-Preschool (BRIEF-P): Selected subscales

Child Behavior Rating Scale (CBRS)

Classroom Observations

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Unstuck and On Target: Preschool

2021

N/A

~70

0 / 1Eligibility criteria met