Executive DysfunctionNCT05131659
Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD
A study testing Executive function group therapy in people with Executive Dysfunction and Autism Spectrum Disorder, run by Children's National Research Institute at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Executive Dysfunction, Autism Spectrum Disorder, Adolescent Behavior
- What is being tested?
- Executive function group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Oct 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's National Hospital
Washington D.C., District of Columbia, 20010
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
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.
- Being tested
- Executive function group therapy
- Keywords
- Autism Spectrum Disorder, Executive Function, Intervention, MRI Scanning, Neuroimaging, Learning Mechanisms
- Medical subject headings
- Autism Spectrum Disorder, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive function group therapyBehavioural
Also called Proprietary name: Unstuck & On Target (UOT:HS)
This executive function group therapy curriculum for adolescents uses cognitive behavioral therapy techniques, and focuses on key functions needed for adult success, such as: self-advocacy, flexibility, time management, motivation, goal setting, developing plans, monitoring progress. Guided practice begins with concrete interventionist support and moves to interventionist cueing, self-cueing, and finally automatic use of the skills without support.
| Study group | Role | What they receive |
|---|---|---|
| Executive function group therapy | Experimental | Not described Receives: Behavioral: Executive function group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Executive Function Challenge Task (EFCT) Scores
The EFCT is an objective and ecologically valid task developed by our research team to assess flexibility and planning skills in a social context conducted by a trained research staff member masked to treatment condition. The EFCT uses a standardized, semi-structured protocol which does not provide explicit rules for completing the tasks to mimic the implicit, unspoken, unstructured expectations in everyday life. The EFCT consists of challenges across several activities and responses are scored on a 3-point scale for each task. The scale (0-good, 1-intermediate, 2-poor performance) has task-specific behavioral markers to guide scoring.
Measured: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Change in Neural Response During Prototype Learning Task Outcomes
The Prototype Task measures learning of abstract representations in the visual domain. The task requires classification into two categories of visual exemplars characterized by a number of features (e.g., cartoon fish with features such as a particular eye shape, fins, body shape etc.) for training with feedback. Following training, generalization of learned information is tested on exemplars that are similar to training items but have never been presented before. Participants perform the generalization phase in an MRI scanner for measurement of brain activation. Learning of abstract visual representation (e.g., prototype learning) on this task is indicated by engagement of medial prefrontal cortex (mPFC)
Measured: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Secondary outcomes (1)
Change in Adaptive Behavior Assessment System, Third Edition (ABAS-3) scores
Adaptive behavior will be measured via parent-report on the Adaptive Behavior Assessment System, Third Edition (ABAS-3). The ABAS-3 is a well-validated parent report measure that assesses practical, everyday skills needed to effectively and independently take care of oneself and interact with others across the lifespan.
Measured: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start20 Oct 2021
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Executive DysfunctionStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Lauren Kenworthy, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131659
- Sponsor's protocol ID
- Pro00015492
- Other IDs
- 1P50HD105328-01
- Status last verified
- Feb 2026
- First submitted
- 30 Sep 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bertollo JR, Baczewski L, Behar H, Black ER, Anderson T, Sharp K, Lopez A, Neuman CC, Verbalis A, Pugliese CE, Kenworthy L. Self- and parent-reported executive function and self-determination in autistic teens: domain-specific relationships and cross-rater considerations. J Neurodev Disord. 2026 Aug 3;18(1):61. doi: 10.1186/s11689-026-09703-2.
PubMed 42958037
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD
- ClinicalTrials.gov ID
- NCT05131659
- Acronym / sponsor ID
- Pro00015492
- Keywords
- Autism Spectrum Disorder, Executive Function, Intervention, MRI Scanning, Neuroimaging, Learning Mechanisms
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Collaborators
- Georgetown University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Executive function group therapy | Experimental | Behavioral: Executive function group therapy |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Executive function group therapyAlso: Proprietary name: Unstuck & On Target (UOT:HS)This executive function group therapy curriculum for adolescents uses cognitive behavioral therapy techniques, and focuses on key functions needed for adult success, such as: self-advocacy, flexibility, time management, motivation, goal setting, developing plans, monitoring progress. Guided practice begins with concrete interventionist support and moves to interventionist cueing, self-cueing, and finally automatic use of the skills without support. | Behavioural | Executive function group therapy |
Primary outcome
Change in Executive Function Challenge Task (EFCT) Scores
Time frame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
The EFCT is an objective and ecologically valid task developed by our research team to assess flexibility and planning skills in a social context conducted by a trained research staff member masked to treatment condition. The EFCT uses a standardized, semi-structured protocol which does not provide explicit rules for completing the tasks to mimic the implicit, unspoken, unstructured expectations in everyday life. The EFCT consists of challenges across several activities and responses are scored on a 3-point scale for each task. The scale (0-good, 1-intermediate, 2-poor performance) has task-specific behavioral markers to guide scoring.
Change in Neural Response During Prototype Learning Task Outcomes
Time frame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
The Prototype Task measures learning of abstract representations in the visual domain. The task requires classification into two categories of visual exemplars characterized by a number of features (e.g., cartoon fish with features such as a particular eye shape, fins, body shape etc.) for training with feedback. Following training, generalization of learned information is tested on exemplars that are similar to training items but have never been presented before. Participants perform the generalization phase in an MRI scanner for measurement of brain activation. Learning of abstract visual representation (e.g., prototype learning) on this task is indicated by engagement of medial prefrontal cortex (mPFC)
1 secondary outcome
Change in Adaptive Behavior Assessment System, Third Edition (ABAS-3) scores
Time frame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Derived from this study: PubMed 42958037Bertollo JR, Baczewski L, Behar H, Black ER, Anderson T, Sharp K, Lopez A, Neuman CC, Verbalis A, Pugliese CE, Kenworthy L. Self- and parent-reported executive function and self-determination in autistic teens: domain-specific relationships and cross-rater considerations. J Neurodev Disord. 2026 Aug 3;18(1):61. doi: 10.1186/s11689-026-09703-2.
- Individual participant dataSharing planned: No
Related trials for Executive Dysfunction
Active, not recruiting
Learning by Heart: The Effectiveness of an EF Training Program for Pre-schoolers With Critical CHD
Congenital Heart Disease, Executive Dysfunction
Recruiting
Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
TBI, Cognitive Dysfunction
Active, not recruitingPhase 3
Goal-Directed Sedation in Mechanically Ventilated Infants and Children
Delirium, Critical Illness
Recruiting
Executive Function Intervention for Children With Complex Congenital Heart Disease
Heart Defect, Congenital, Executive Dysfunction
Active, not recruiting
COMPuter-assisted Self-training to Improve EXecutive Function
Parkinson Disease, Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Executive function group therapy in people with Executive Dysfunction and Autism Spectrum Disorder, run by Children's National Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Executive Function Challenge Task (EFCT) Scores (time frame: 8-12 months before intervention, at start of intervention, 8-12 months after intervention begins). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05131659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.