NCT05131659

Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Children's National Research Institute · Academic / Other
• Sex: All
• Age: 14 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Executive Dysfunction
• Autism Spectrum Disorder
• Adolescent Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Executive function group therapy	This executive function group therapy curriculum for adolescents uses cognitive behavioral therapy techniques, and focuses on key functions needed for adult success, such as: self-advocacy, flexibility, time management, motivation, goal setting, developing plans, monitoring progress. Guided practice begins with concrete interventionist support and moves to interventionist cueing, self-cueing, and finally automatic use of the skills without support.

Timeline

• Start date: 2021-10-20
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2021-11-23
• Last updated: 2026-02-12

Locations

2 sites across 1 country: United States