Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD (NCT05131659) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD
United States64 participantsStarted 2021-10-20
Plain-language 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.
Who can participate
Age range14 Years – 18 Years
SexALL
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Inclusion criteria
✓. 14-18 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.
Exclusion criteria
✕
What they're measuring
1
Change in Executive Function Challenge Task (EFCT) Scores
Timeframe: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
2
Change in Neural Response During Prototype Learning Task Outcomes
Timeframe: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
. 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).