Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD

Last updated: February 23, 2024
Sponsor: Children's National Research Institute
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Williams Syndrome

Asperger's Disorder

Treatment

Executive function group therapy

Clinical Study ID

NCT05131659
Pro00015492
1P50HD105328-01
  • Ages 14-18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 14-18 years of age inclusive
  2. Full scale IQ > 80 on a standardized IQ test, either confirmed through educationaltesting within the last two years or confirmed by the Wechsler Abbreviated Scale ofIntelligence (WASI-2) administered by research personnel. If current IQ testing (FSIQ)is not interpretable based on discrepancies between verbal and perceptual skills, wewill use the best available verbal IQ estimate.
  3. Broad ASD diagnosis according to Diagnostic Statistical Manual, fifth edition (DSM-5)criteria established by parent report of prior clinical diagnosis and confirmed bymeeting cutoff criteria on the Social Communication Questionnaire (i.e., raw score >
  1. or the Autism Diagnostic Observation Schedule-2 (ADOS-2), Module 4 (total score ≥7).
  1. Intact or corrected hearing and vision.
  2. Parents/guardians speak and read English with sufficient fluency for completion ofconsent forms and informant questionnaires; youth participants will use/understandEnglish as a primary or secondary language with sufficient fluency to engageeffectively in executive function group therapy conducted in English, and for validadministration of neuropsychological and behavioral measures.

Exclusion

Exclusion Criteria:

  1. Presence of a known medical condition in the participant that would interfere withhis/her ability to participate in the study.
  2. To preserve the integrity of the neuroimaging data, participants will be excluded ifthey have a history of neurological disorder, such as an established epilepsydiagnosis, significant brain trauma, hydrocephalus, central nervous system infection,or stroke.
  3. Contraindications for MRI such as metal implants, dental braces, pregnancy (determinedby parent or self-report).

Study Design

Total Participants: 64
Treatment Group(s): 1
Primary Treatment: Executive function group therapy
Phase:
Study Start date:
October 20, 2021
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Children's National Hospital

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Georgetown University

    Washington, District of Columbia 20057
    United States

    Site Not Available

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