Back to resultsIntervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD
Primary Purpose
Executive Dysfunction, Autism Spectrum Disorder, Adolescent Behavior
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Executive function group therapy
Sponsored by
About this trial
This is an interventional treatment trial for Executive Dysfunction focused on measuring Autism Spectrum Disorder, Executive Function, Intervention, MRI Scanning, Neuroimaging, Learning Mechanisms
Eligibility Criteria
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:
- 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).
Sites / Locations
- Children's National HospitalRecruiting
- Georgetown University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Executive function group therapy
Arm Description
Outcomes
Primary Outcome Measures
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.
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)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05131659
First Posted
September 30, 2021
Last Updated
September 1, 2023
Sponsor
Children's National Research Institute
Collaborators
Georgetown University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05131659
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's National Research Institute
Collaborators
Georgetown University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Executive Dysfunction, Autism Spectrum Disorder, Adolescent Behavior
Keywords
Autism Spectrum Disorder, Executive Function, Intervention, MRI Scanning, Neuroimaging, Learning Mechanisms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Executive function group therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Executive function group therapy
Other Intervention Name(s)
Proprietary name: Unstuck & On Target (UOT:HS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Executive Function Challenge Task (EFCT) Scores
Description
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.
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Title
Change in Neural Response During Prototype Learning Task Outcomes
Description
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)
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Secondary Outcome Measure Information:
Title
Change in Adaptive Behavior Assessment System, Third Edition (ABAS-3) scores
Description
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.
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Other Pre-specified Outcome Measures:
Title
Change in Prototype Task Performance: Learning Strategy Scores
Description
Generalization phase learning can be characterized by strategy using computational modeling. Two models are tested; 1. learning from having abstracted information that is prototypical of the category (e.g., family of fish as described above); 2. Learning from matching exemplar information to training phase
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Title
Change in Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2) Scores
Description
The BRIEF-2 is a well-established self-report measure of real-world EF skills, with the Shift subscale measuring cognitive flexibility.
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
Title
Change in Dimensional Change Card Sort Test (DCCS) Scores
Description
The Dimensional Change Card Sort Test (NIH Toolbox) is a 4-minute, standard lab-based task for assessing cognitive flexibility in terms of set-shifting. Participants are required to sort a series of bivalent cards first according to one dimension (e.g., color) and then according to another (e.g., shape). It is normed from ages 4-85
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Title
Change in Flexibility Scale Scores
Description
The Flexibility Scale (FS) is a 27-item measure assessing five categories related to flexibility: routines and rituals, transitions/change, special interests, social flexibility and generativity
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
Title
Change in CVLT-C Scores
Description
California Verbal Learning Test Children's Version (CVLT-C) is used to assess verbal learning and memory through an everyday memory task in which the child is asked to recall a list. The measure is for children and adolescents 5 through 16.11 years
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Title
Change in CVLT-3 Scores
Description
California Verbal Learning Test Adolescent and Adult Version (CVLT-3) is used to assess verbal learning and memory through an everyday memory task in which the individual is asked to recall a list. The measure is for Individuals between 16-90 years old
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Title
Change in ASC - ASD Scores
Description
The Anxiety Scale for Children- ASD (ASC-ASD) is a 24 item self-report anxiety questionnaire, with four sub-scales: Separation Anxiety (SA), Uncertainty (U), Performance Anxiety (PA) and Anxious Arousal (AA), for use with young people aged between 8-16 years with a diagnosis of autism spectrum disorder (ASD).
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
Title
Change in AIR-SDS Scores
Description
The AIR Self-Determination scale (AIR-SDS) produces a profile of the student's level of self-determination, identifies areas of strength and areas needing improvement, identifies specific educational goals that can be incorporated into the student's individualized education plan (IEP). The measure examines two broad self-determination components. Capacity refers to the student's knowledge, abilities, and perceptions that enable them to be self-determined. Opportunity refers to the student's chances to use their knowledge and abilities
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
Title
Change in PRAS-ASD Scores
Description
Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) is 25-item measure for anxiety. This is a reliable and valid measure that can be used to assess severity of anxiety in youth with ASD and evaluate change with treatment
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
Title
Change in Rey Complex Figure Test and Recognition Trial Scores
Description
Rey Complex Figure Test and Recognition Trial (RCFT) tests visuospatial constructional ability and visuospatial memory using the "complex figure." The RCFT consists of four separate tasks and is scored using specific criteria developed for scoring the accuracy and placement of individual units of the complex figure
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins
Title
Change in BDI-II Scores
Description
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
Time Frame
8-12 months before intervention, at start of intervention, 8-12 months after intervention begins, 8-12 months after intervention ends
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Kenworthy
Phone
301-765-5430
Email
lkenwort@childrensnational.org
First Name & Middle Initial & Last Name or Official Title & Degree
Chandan Vaidya
Phone
703-399-0130
Email
cjv2@georgetown.edu
Facility Information:
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Kenworthy, PhD
Phone
301-765-5430
Email
lkenwort@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Lauren Kenworthy, PhD
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intervention-Induced Plasticity of Flexibility and Learning Mechanisms in ASD
We'll reach out to this number within 24 hrs