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Clinical Trials/NCT05135728
NCT05135728
Completed
Not Applicable

Development and Pilot Testing of a Novel Preschool Executive Function Curriculum Development of an Executive Function Intervention for Adolescents With Autism Spectrum Disorders

Children's National Research Institute1 site in 1 country63 target enrollmentNovember 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Executive Dysfunction
Sponsor
Children's National Research Institute
Enrollment
63
Locations
1
Primary Endpoint
Acceptability of Intervention
Status
Completed
Last Updated
last year

Overview

Brief Summary

Executive function (EF) skills are a set of essential cognitive abilities that enable individuals to demonstrate their knowledge and talents, effectively complete tasks and navigate social interactions through flexible regulation of their thinking, behavior and emotions. EF is strongly linked to academic readiness and long-term educational outcomes. Children's EF is impacted by poverty-related experiences and is also impaired in the increasing number of children with developmental and emotional disabilities. Interventions targeting EF skills hold particular promise for improving children's educational trajectories by leveraging brain plasticity in the preschool period. We will directly target EF skills in preschoolers with poor EF. This project will address a key source of the achievement gap by meeting the needs of children at the highest risk, those who: 1) show early signs of EF impairment; 2) live in low-income communities and 3) are at risk for developmental and emotional disabilities (DD/ED). The intervention is a downward extension of Unstuck and On Target for elementary school (UOT; Cannon, Kenworthy, Alexander, Werner, & Anthony, 2018), an EF intervention shown to be effective at increasing children's learning behaviors, as delivered by school staff. The research team will partner with key stakeholders to revise and iteratively refine UOT-P through a development trial, utilizing participant, teacher and parent feedback. The results of this trial will be leveraged to enable the team to apply for future federal funding for a randomized comparative effectiveness trial (NIH, Institute of Educational Sciences, Patient-Centered Outcomes Research Institute).

Registry
clinicaltrials.gov
Start Date
November 15, 2021
End Date
August 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Children's National Research Institute
Responsible Party
Principal Investigator
Principal Investigator

Allison Ratto

Psychologist, Center for Autism Spectrum Disorders

Children's National Research Institute

Eligibility Criteria

Inclusion Criteria

  • Enrolled as a student at a participating school site OR as a patient at a participating clinic site
  • Chronological age between 3-6 years at enrollment
  • English as a primary language
  • Roughly age-appropriate core language skills as determined by referring school staff or provider
  • Identified by school staff or provider as having problems with flexibility

Exclusion Criteria

  • No longer enrolled at participating school or clinic site
  • Insufficient English fluency or language skills to complete intervention

Outcomes

Primary Outcomes

Acceptability of Intervention

Time Frame: Through study completion, average of 20 weeks

Acceptability will be measured via interventionist ratings on the Acceptability of Intervention Measure (AIM). Scores range from 4-20, where higher scores indicate higher acceptability.

Intervention Appropriateness

Time Frame: Through study completion, average of 20 weeks

Acceptability will be measured via interventionist ratings on the the Intervention Appropriateness Measure (IAM) at outcome.

Feasibility of Intervention

Time Frame: Through study completion, average of 20 weeks

Interventionist ratings of feasibility will serve as the primary outcome measure. Interventionists will rate overall intervention feasibility using the Feasibility of Intervention Measure (FIM) at outcome. Scores range 4-20, where higher scores indicate higher feasibility.

Feasibility - Child Attendance

Time Frame: Through study completion, average of 20 weeks

Child attendance at groups will also be tracked.

Secondary Outcomes

  • Interventionist Knowledge(baseline, end of intervention - an average of 20 weeks between baseline and end of intervention)
  • Fidelity Observations(twice throughout intervention period, average of 6 weeks between observations)

Study Sites (1)

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