Clinical trial NCT05131659: Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD
Official title: Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Executive Dysfunction
Autism Spectrum Disorder
Adolescent Behavior
Keywords: Autism Spectrum Disorder
Executive Function
Intervention
MRI Scanning
Neuroimaging
Learning Mechanisms
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
Collaborators: name: Georgetown University
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-11-23
Enrollment: 64
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in Executive Function Challenge Task (EFCT) Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
measure: 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
Secondary outcomes:
measure: Change in Adaptive Behavior Assessment System, Third Edition (ABAS-3) scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Other outcomes:
measure: Change in Prototype Task Performance: Learning Strategy Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
measure: Change in Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
measure: Change in Dimensional Change Card Sort Test (DCCS) Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
measure: Change in Flexibility Scale Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
measure: Change in CVLT-C Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
measure: Change in CVLT-3 Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
measure: Change in ASC - ASD Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
measure: Change in AIR-SDS Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
measure: Change in PRAS-ASD Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
measure: Change in Rey Complex Figure Test and Recognition Trial Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
measure: Change in BDI-II Scores
timeFrame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: Washington
country: United States
facility: Georgetown University
state: District of Columbia
Study officials:
References: