Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD

Children's National

Status: Active, not recruiting

Conditions: Autism Spectrum Disorder; Adolescent Behavior; Executive Dysfunction

Treatments: Behavioral: Executive function group therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05131659

1P50HD105328-01 (U.S. NIH Grant/Contract)

Pro00015492

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 14 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 14-18 years of age inclusive
2. 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.
3. 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).
4. Intact or corrected hearing and vision.
5. 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

1. Presence of a known medical condition in the participant that would interfere with his/her ability to participate in the study.
2. 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.
3. Contraindications for MRI such as metal implants, dental braces, pregnancy (determined by parent or self-report).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Executive function group therapy

Experimental group

Treatment:

Behavioral: Executive function group therapy