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NCT05131659 · ClinicalTrials.gov registry record · NA

Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD

A NA study of Autism Spectrum Disorder and Adolescent Behavior, sponsored by Children's National Research Institute.

Active
Registry status
NA
Development phase
64
Enrollment target
2
Study locations

NCT05131659 is a NA study of Autism Spectrum Disorder and Adolescent Behavior that is active but no longer recruiting, run by Children's National Research Institute. The registered enrollment target is 64 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (53% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT05131659, a NA study of Autism Spectrum Disorder and Adolescent Behavior, is active but no longer recruiting, sponsored by Children's National Research Institute.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
64 participants
Enrollment target
2
Study locations

Study Summary

This project explores the association between learning and cognitive flexibility by testing whether a cognitive behavioral intervention designed to improve flexibility in ASD changes learning and associated neural activation using model-based functional magnetic resonance imaging (m-fMRI). The study proposes that variability in learning mechanisms is associated with behavioral flexibility and explains differences in adaptive and treatment outcomes. The study employs a longitudinal case-controlled design in 60 14-18 year old youth with ASD at 3 time-points 8 months apart, each including m-fMRI during learning and behavioral measurement of executive and adaptive function. Aim 1 tests the hypothesis that individual variation in learning biases and their neural correlates predicts behavioral flexibility and is stable over time. Aim 2 tests plasticity of learning mechanisms induced by a cognitive-behavioral intervention for flexibility. Aim 3 tests hypothesis about intervention-induced plasticity of neural functional connectivity.

Interventions

  • BEHAVIORAL Executive function group therapy

Study Locations (2)

District of Columbia

  • Children's National Hospital - Washington D.C.
  • Georgetown University - Washington D.C.

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2021-10-20
Est. Completion 2026-05-31
Phase NA

What the Registry Record Tells You About NCT05131659

The ClinicalTrials.gov registry entry for NCT05131659 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (53% lower). The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Executive function group therapy is the first listed.

NCT05131659 reports 2 study locations spanning 1 distinct geographic area - top geographies include District of Columbia.

Frequently Asked Questions

What is clinical trial NCT05131659 about?

NCT05131659 is a clinical study titled "Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD". This project explores the association between learning and cognitive flexibility by testing whether a cognitive behavioral intervention designed to improve flexibility in ASD changes learning and associated neural activation using model-based functional magnetic resonance imaging (m-fMRI). The study...

What is the current status of trial NCT05131659?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 64 participants. The study started on 2021-10-20. Estimated completion is 2026-05-31.

What conditions does trial NCT05131659 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder, Adolescent Behavior, Executive Dysfunction.

What interventions are being tested in trial NCT05131659?

The interventions under investigation include: Executive function group therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT05131659?

This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05131659 being conducted?

This trial has 2 study locations across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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