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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 belowSelect...
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
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 moreSecondary 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 moreAwards & 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
Find a Location
Who is running the clinical trial?
The Maddux SchoolUNKNOWN
AppleTree InstituteUNKNOWN
Children's National Research InstituteLead Sponsor
221 Previous Clinical Trials
258,307 Total Patients Enrolled
2 Trials studying Executive Dysfunction
288 Patients Enrolled for Executive Dysfunction
Lauren KenworthyPrincipal InvestigatorChildren's National
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My language skills are appropriate for my age, as confirmed by my school or doctor.I am between 3 and 6 years old.I have been identified as having issues with flexibility.
Research Study Groups:
This trial has the following groups:- Group 1: Waitlist Control
- Group 2: Unstuck and On Target-Preschool
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Executive Dysfunction Patient Testimony for trial: Trial Name: NCT05135728 — N/A