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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 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

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).

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Maddux SchoolUNKNOWN

AppleTree InstituteUNKNOWN

Children's National Research InstituteLead Sponsor

210 Previous Clinical Trials

207,702 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial permit enrolment for individuals over thirty years of age?

"This investigation is open to children aged 3-6 years old."

Answered by AI

What criteria must one meet to be accepted into this clinical trial?

"This clinical trial is enlisting 55 children between 3 and 6 years of age who have executive functioning deficits. The following criteria must also be met: enrollment at a collaborating school or clinic, English as the native language, commensurate communication abilities deemed by a teacher or provider, and documented issues with adaptability according to faculty or medical personnel."

Answered by AI

Are there current opportunities to join this clinical exploration?

"As per available data from clinicaltrials.gov, this trial is not presently accepting enrolments, with the initial posting taking place on November 15th 2021 and last update being registered on November 2nd 2022. However, there are 21 other active studies seeking participants at present."

Answered by AI

Who else is applying?

What state do they live in?

Maryland

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

What site did they apply to?

Children's National Hospital

Why did patients apply to this trial?

I decided to apply to this trial because my son (age 3) was diagnosed with Level 1 ASD, and we believe his inflexibility/rigidity in certain situations is his biggest challenge. His psychologist Dr. Katerina Dudley advised we begin using Plan A/Plan B strategies, preparing him verbally in advance for changes, and a host of other methods that we have found to be successful. This trial sounds very interesting, and one we think our son will be receptive to.

PatientReceived 2+ prior treatments

Recent research and studies

clinicaltrials.govStudy

Development and Pilot Testing of a Novel Preschool Executive Function Curriculum

Allison Ratto 2021. "Development and Pilot Testing of a Novel Preschool Executive Function Curriculum". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05135728.

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