NCT05131659Active, not recruiting
Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 64 (actual)
- First submitted
- 30 Sept 2021
- Start date
- 20 Oct 2021
- Primary completion date
- 31 May 2026
- Lead sponsor
- Children's National Research Institute
- Diseases
- Autism
- NCT number
- NCT05131659
What you commit to
- Study type: Interventional
- Participants enrolled: 64
- From 20 Oct 2021 to the primary completion date, 31 May 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications for MRI such as metal implants, dental braces, pregnancy (determined by parent or self-report).
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 14 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's National Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
| Georgetown University Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
Related publications
- Self- and parent-reported executive function and self-determination in autistic teens: domain-specific relationships and cross-rater considerations.J Neurodev Disord · 2026 · PMID 42958037
This page is information, not medical advice. Discuss any trial with your doctor.