Ignite Creation Date:
2024-05-06 @ 10:14 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03199937
Status:
COMPLETED
Last Update Posted:
2020-04-10
First Post:
2017-06-21
Brief Title:
Executive Function Intervention for High School Students With ASD
Sponsor:
Childrens National Research Institute
Organization:
Childrens National Research Institute
Study Overview
Official Title:
Behavioral and Neural Outcomes of a New Executive Function Treatment for Transition-age Youth With ASD
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this project is to test the effectiveness of a novel school-based intervention targeting executive function skills including flexibility and planning in college-track transition-age youth with ASD Evaluating treatment change through behavior and brain activity provides important information on how the treatment works and who will best benefit from it
Detailed Description:
With half of the 32 million lifetime per capita cost of autism spectrum disorder ASD attributable to care and productivity loss during adult life the Interagency Autism Coordinating Committee has identified a pressing need to improve adult outcomes Even in individuals without intellectual disability who make up 23 of children with ASD as few as 9 reach full functional independence as adults Failure in college is related to weaknesses in executive function EF specifically with flexibility and planning As such the transition from high school is a period of amplified risk characterized by poor educational and vocational attainment that persists in adulthood EF problems are pivotal targets for intervention because they are common linked to independence and responsive to treatment in younger children There are three barriers to treatment outcome research in transition-aged youth with ASD 1 a lack of proven EF treatments for this age 2 pervasive failure to generalize skills learned in the clinic to real-world settings and 3 inadequate objective measures of outcome This proposal tests the effectiveness of Flexible Futures a new phenotype specific cognitive behavioral EF intervention to increase flexibility and planning skills for college-track high school students with ASD It is novel and innovative because its use of translational methods comprehensively evaluates treatment change at the behavioral cognitive and neural level
Cognitive flexibility and planning are impaired in ASD linked to core ASD symptoms and embedded in anomalies of brain structure and function Individuals with ASD fail to activate local cortical regions such as dorsolateral prefrontal cortex DLPFC and anterior cingulate cortex ACC on set-shifting flexibility tasks and show global abnormalities in the default mode salience and attentional networks associated with EF problems in attending to important information and implementing goal-directed behavior In typical development greater segregation between and greater connectivity within these networks is associated with better cognitive and behavioral regulation Dr Pugliese aims to determine whether treatment change can be objectively measured in the brain using functional MRI fMRI This cutting edge methodology is critical to identifying processes of treatment change at the neural level consistent with the NIMH Research Domain Criteria framework and may yield findings that impact the large variety of psychiatric and developmental disorders linked to EF deficits Specifically this study aligns with NIMH K23 guidance soliciting proposals for the development of pilot studies of novel treatments eliciting mechanisms of change
AIM 1 Refine the Flexible Futures treatment manual and test acceptability feasibility and effectiveness in a school setting
Dr Pugliese will refine the Flexible Futures manual based on expert opinion and feedback from our in-clinic pilot via an iterative process and run a school-based trial comparing Flexible Futures to social skills treatment It is hypothesized that intervention acceptability feasibility and fidelity will reach an 80 benchmark H11 and students who receive Flexible Futures will show improved EF flexibility and planning abilities in laboratory school and home settings post-treatment and at 5-month follow up compared to students who receive treatment as usual H12
AIM 2 Identify neural correlates of treatment change using fMRI
Task-evoked and resting-state activation of prefrontal cortex networks will be assessed pre-post-intervention It is hypothesized that post-treatment students receiving Flexible Futures will display increased normalized DLPFC and ACC activation during a well-established set-shifting task compared to those receiving social skills training H21 and that activation will be positively correlated with behavioralcognitive measures of EF H22 It is also hypothesized that post-treatment students receiving Flexible Futures will display increased connectivity within and decreased connectivity across default mode salience and attentional networks compared to the control group H23
AIM 3 Identify biomarkers of later EF outcomes at the behavioral cognitive and neural level
Baseline data will be combined across participants to provide a comprehensive EF profile in transition-age youth and identify predictors of later EF and global outcomes It is hypothesized that baseline measures of EF behavioral cognitive DLPFCACC activation and greater connectivity within and greater segregation between salience attentional and default mode networks neural will all predict EF outcome and adaptive function H31
Significance Establishing the first effective school-based EF treatment for high-schoolers will provide critical and generalizable transition-related support and a model for treatment in other prevalent disorders with known EF deficits eg ADHD anxiety This training award will launch me toward Dr Puglieses ultimate career goals of 1 developing and implementing innovative interventions personalized for specific cognitive profiles 2 developing school-based treatments to overcome disparities in access to healthcare and 3 utilizing treatment studies as vehicles to identify biomarkers and provide insight into neural correlates of treatment change
Cognitive flexibility and planning are impaired in ASD linked to core ASD symptoms and embedded in anomalies of brain structure and function Individuals with ASD fail to activate local cortical regions such as dorsolateral prefrontal cortex DLPFC and anterior cingulate cortex ACC on set-shifting flexibility tasks and show global abnormalities in the default mode salience and attentional networks associated with EF problems in attending to important information and implementing goal-directed behavior In typical development greater segregation between and greater connectivity within these networks is associated with better cognitive and behavioral regulation Dr Pugliese aims to determine whether treatment change can be objectively measured in the brain using functional MRI fMRI This cutting edge methodology is critical to identifying processes of treatment change at the neural level consistent with the NIMH Research Domain Criteria framework and may yield findings that impact the large variety of psychiatric and developmental disorders linked to EF deficits Specifically this study aligns with NIMH K23 guidance soliciting proposals for the development of pilot studies of novel treatments eliciting mechanisms of change
AIM 1 Refine the Flexible Futures treatment manual and test acceptability feasibility and effectiveness in a school setting
Dr Pugliese will refine the Flexible Futures manual based on expert opinion and feedback from our in-clinic pilot via an iterative process and run a school-based trial comparing Flexible Futures to social skills treatment It is hypothesized that intervention acceptability feasibility and fidelity will reach an 80 benchmark H11 and students who receive Flexible Futures will show improved EF flexibility and planning abilities in laboratory school and home settings post-treatment and at 5-month follow up compared to students who receive treatment as usual H12
AIM 2 Identify neural correlates of treatment change using fMRI
Task-evoked and resting-state activation of prefrontal cortex networks will be assessed pre-post-intervention It is hypothesized that post-treatment students receiving Flexible Futures will display increased normalized DLPFC and ACC activation during a well-established set-shifting task compared to those receiving social skills training H21 and that activation will be positively correlated with behavioralcognitive measures of EF H22 It is also hypothesized that post-treatment students receiving Flexible Futures will display increased connectivity within and decreased connectivity across default mode salience and attentional networks compared to the control group H23
AIM 3 Identify biomarkers of later EF outcomes at the behavioral cognitive and neural level
Baseline data will be combined across participants to provide a comprehensive EF profile in transition-age youth and identify predictors of later EF and global outcomes It is hypothesized that baseline measures of EF behavioral cognitive DLPFCACC activation and greater connectivity within and greater segregation between salience attentional and default mode networks neural will all predict EF outcome and adaptive function H31
Significance Establishing the first effective school-based EF treatment for high-schoolers will provide critical and generalizable transition-related support and a model for treatment in other prevalent disorders with known EF deficits eg ADHD anxiety This training award will launch me toward Dr Puglieses ultimate career goals of 1 developing and implementing innovative interventions personalized for specific cognitive profiles 2 developing school-based treatments to overcome disparities in access to healthcare and 3 utilizing treatment studies as vehicles to identify biomarkers and provide insight into neural correlates of treatment change
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OAR Innovative Research Award | OTHER | Organization for Autism Research | None |