Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD

NCT05131659 | Active Not Recruiting

• 2 other identifiers: Pro000154921P50HD105328-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Autism Spectrum Disorder; Executive Function; Intervention; MRI Scanning; Neuroimaging; Learning Mechanisms

Outcome Measures

Primary Outcomes (2)

• Change in Executive Function Challenge Task (EFCT) Scores

  The EFCT is an objective and ecologically valid task developed by our research team to assess flexibility and planning skills in a social context conducted by a trained research staff member masked to treatment condition. The EFCT uses a standardized, semi-structured protocol which does not provide explicit rules for completing the tasks to mimic the implicit, unspoken, unstructured expectations in everyday life. The EFCT consists of challenges across several activities and responses are scored on a 3-point scale for each task. The scale (0-good, 1-intermediate, 2-poor performance) has task-specific behavioral markers to guide scoring.

  8-12 months before intervention, at start of intervention, 8-12 months after intervention begins

• Change in Neural Response During Prototype Learning Task Outcomes

  The Prototype Task measures learning of abstract representations in the visual domain. The task requires classification into two categories of visual exemplars characterized by a number of features (e.g., cartoon fish with features such as a particular eye shape, fins, body shape etc.) for training with feedback. Following training, generalization of learned information is tested on exemplars that are similar to training items but have never been presented before. Participants perform the generalization phase in an MRI scanner for measurement of brain activation. Learning of abstract visual representation (e.g., prototype learning) on this task is indicated by engagement of medial prefrontal cortex (mPFC)

  8-12 months before intervention, at start of intervention, 8-12 months after intervention begins

Secondary Outcomes (1)

• Change in Adaptive Behavior Assessment System, Third Edition (ABAS-3) scores

  8-12 months before intervention, at start of intervention, 8-12 months after intervention begins

Other Outcomes (11)

• Change in Prototype Task Performance: Learning Strategy Scores

  8-12 months before intervention, at start of intervention, 8-12 months after intervention begins

• Change in Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) Scores

  8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends

• Change in Dimensional Change Card Sort Test (DCCS) Scores

  8-12 months before intervention, at start of intervention, 8-12 months after intervention begins

Study Arms (1)

Executive function group therapy

EXPERIMENTAL

Behavioral: Executive function group therapy

Interventions

Executive function group therapy BEHAVIORAL

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.

Also known as: Proprietary name: Unstuck & On Target (UOT:HS)

Executive function group therapy

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years of age inclusive
• Full scale IQ \> 80 on a standardized IQ test, either confirmed through educational testing within the last two years or confirmed by the Wechsler Abbreviated Scale of Intelligence (WASI-2) administered by research personnel. If current IQ testing (FSIQ) is not interpretable based on discrepancies between verbal and perceptual skills, we will use the best available verbal IQ estimate.
• Broad ASD diagnosis according to Diagnostic Statistical Manual, fifth edition (DSM-5) criteria established by parent report of prior clinical diagnosis and confirmed by meeting cutoff criteria on the Social Communication Questionnaire (i.e., raw score \> 11) or the Autism Diagnostic Observation Schedule-2 (ADOS-2), Module 4 (total score ≥7).
• Intact or corrected hearing and vision.
• Parents/guardians speak and read English with sufficient fluency for completion of consent forms and informant questionnaires; youth participants will use/understand English as a primary or secondary language with sufficient fluency to engage effectively in executive function group therapy conducted in English, and for valid administration of neuropsychological and behavioral measures.

You may not qualify if:

• Presence of a known medical condition in the participant that would interfere with his/her ability to participate in the study.
• To preserve the integrity of the neuroimaging data, participants will be excluded if they have a history of neurological disorder, such as an established epilepsy diagnosis, significant brain trauma, hydrocephalus, central nervous system infection, or stroke.
• Contraindications for MRI such as metal implants, dental braces, pregnancy (determined by parent or self-report).

Sponsors & Collaborators

• Children's National Research Institute: lead
• Georgetown University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Adolescent Behavior

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC CHIEF NEUROPSYCHOLOGY

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: November 23, 2021
• Study Start: October 20, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)