Executive Function Intervention for High School Students With ASD
NCT ID: NCT03199937
Last Updated: 2020-04-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
68 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-07-11
Study Completion Date
2019-06-30
Brief Summary
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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.
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Detailed Description
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With half of the $3.2 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 2/3 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 (H1.1) 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 (H1.2).
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 (H2.1), and that activation will be positively correlated with behavioral/cognitive measures of EF (H2.2). 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 (H2.3).
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); DLPFC/ACC activation; and greater connectivity within and greater segregation between salience, attentional and default mode networks (neural) will all predict EF outcome and adaptive function. (H3.1).
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 (e.g. ADHD, anxiety). This training award will launch me toward Dr. Pugliese's 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 (H1.1) 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 (H1.2).
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 (H2.1), and that activation will be positively correlated with behavioral/cognitive measures of EF (H2.2). 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 (H2.3).
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); DLPFC/ACC activation; and greater connectivity within and greater segregation between salience, attentional and default mode networks (neural) will all predict EF outcome and adaptive function. (H3.1).
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 (e.g. ADHD, anxiety). This training award will launch me toward Dr. Pugliese's 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.
Conditions
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Autism Spectrum Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Assessor and observers will be blind to the treatment. Classroom observations will be conducted by "partially blind classroom observers." Though the observer will not be told which schools are assigned to which treatment condition, we found that in our last trial occasionally an observer saw treatment materials that suggested which treatment the school had been assigned to. We will make every effort to minimize this, but it may occasionally happen. The pre-post direct child assessments will also be conducted by treatment-blind assessors, as much as possible.
Study Groups
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Flexible Futures
Flexible Futures uses cognitive behavioral therapy (CBT) techniques to target flexibility and planning by teaching core skills through personal goals chosen by students during treatment. Flexible Futures focuses on key functions needed for college success, such as: intrinsic motivation, how to implement skills socially, how thoughts and feelings affect planning and flexibility, self-advocacy skills necessary to promote independence, application of flexibility and organization scripts and strategies in the service of a long-term goal, and management of time and priorities. Guided practice begins with concrete interventionist support, and moves to interventionist cueing, self-cueing, and finally automatic use of the skills without support. Generalization is maximized with school staff as interventionists, parent training, home and classroom extension activities, and role-playing use of strategies in novel situations. Motivation is developed using student choice and natural motivators.
Group Type
EXPERIMENTAL
Flexible Futures
Intervention Type
BEHAVIORAL
Flexible Futures is a novel and innovative cognitive-behavioral treatment that directly addresses executive function and self-regulation deficits in ASD. Flexible futures targets flexibility and planning through self-regulatory scripts that are consistently modeled and reinforced. Scripts compensate for the inner speech and organization/integration deficits in ASD, and are practiced repeatedly to achieve automaticity. Content focuses on key functions needed for college success, such as: intrinsic motivation, how to implement skills socially, self-advocacy skills application of flexibility and organization scripts and strategies in the service of a long-term goal, and management of time and priorities.
Waitlist control group
Current standard of care
Group Type
ACTIVE_COMPARATOR
Current standard of care
Intervention Type
OTHER
Flexible Futures will be compared to a social skills treatment as usual that capitalizes on current standard of care provided by local school districts.
Interventions
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Flexible Futures
Flexible Futures is a novel and innovative cognitive-behavioral treatment that directly addresses executive function and self-regulation deficits in ASD. Flexible futures targets flexibility and planning through self-regulatory scripts that are consistently modeled and reinforced. Scripts compensate for the inner speech and organization/integration deficits in ASD, and are practiced repeatedly to achieve automaticity. Content focuses on key functions needed for college success, such as: intrinsic motivation, how to implement skills socially, self-advocacy skills application of flexibility and organization scripts and strategies in the service of a long-term goal, and management of time and priorities.
Intervention Type
BEHAVIORAL
Current standard of care
Flexible Futures will be compared to a social skills treatment as usual that capitalizes on current standard of care provided by local school districts.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* College-track high school students
* Ages 14-22
* Verbal IQ estimate of ≥ 90 on the Wechsler Abbreviated Intelligence Scale-2
* Clinical diagnosis of ASD OR school classification of autism confirmed by clinical impressions and the Social Responsiveness Scale-Revised total score ≥ 65. If the research staff feels that clinical impressions indicate a diagnosis, but parent report is below threshold, the Autism Diagnostic Observation Schedule-2 will be completed.
* Ages 14-22
* Verbal IQ estimate of ≥ 90 on the Wechsler Abbreviated Intelligence Scale-2
* Clinical diagnosis of ASD OR school classification of autism confirmed by clinical impressions and the Social Responsiveness Scale-Revised total score ≥ 65. If the research staff feels that clinical impressions indicate a diagnosis, but parent report is below threshold, the Autism Diagnostic Observation Schedule-2 will be completed.
Exclusion Criteria
* Bipolar disorder, schizophrenia, or major depression that is currently preventing from participation in classroom activities
* MRI exclusion: contraindication (metal implant or medical device) for MRI
* MRI exclusion: contraindication (metal implant or medical device) for MRI
Minimum Eligible Age
14 Years
Maximum Eligible Age
22 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Georgetown University
OTHER
Sponsor Role
collaborator
Children's National Research Institute
OTHER
Sponsor Role
lead
Responsible Party
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Cara Pugliese
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Cara E Pugliese, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Locations
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Children's Research Institute
Washington D.C., District of Columbia, United States
Site Status
Countries
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United States
References
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Pugliese CE, White SW. Brief report: problem solving therapy in college students with autism spectrum disorders: feasibility and preliminary efficacy. J Autism Dev Disord. 2014 Mar;44(3):719-29. doi: 10.1007/s10803-013-1914-8.
Reference Type
BACKGROUND
Pennington BF, Ozonoff S. Executive functions and developmental psychopathology. J Child Psychol Psychiatry. 1996 Jan;37(1):51-87. doi: 10.1111/j.1469-7610.1996.tb01380.x.
Reference Type
BACKGROUND
Frith U. Why we need cognitive explanations of autism. Q J Exp Psychol (Hove). 2012;65(11):2073-92. doi: 10.1080/17470218.2012.697178. Epub 2012 Aug 21.
Reference Type
BACKGROUND
Ganz ML. The lifetime distribution of the incremental societal costs of autism. Arch Pediatr Adolesc Med. 2007 Apr;161(4):343-9. doi: 10.1001/archpedi.161.4.343.
Reference Type
BACKGROUND
Interagency Autism Coordinating Committee. The 2011 Interagency Autism Coordinating Committee Strategic Plan for Autism Spectrum Disorder Research.; 2011.
Reference Type
BACKGROUND
Farley MA, McMahon WM, Fombonne E, Jenson WR, Miller J, Gardner M, Block H, Pingree CB, Ritvo ER, Ritvo RA, Coon H. Twenty-year outcome for individuals with autism and average or near-average cognitive abilities. Autism Res. 2009 Apr;2(2):109-18. doi: 10.1002/aur.69.
Reference Type
BACKGROUND
Gobbo K, Shmulsky S. Faculty Experience With College Students With Autism Spectrum Disorders: A Qualitative Study of Challenges and Solutions. Focus Autism Other Dev Disabl. 2013;29(1):13-22. doi:10.1177/1088357613504989.
Reference Type
BACKGROUND
Taylor JL, Mailick MR. A longitudinal examination of 10-year change in vocational and educational activities for adults with autism spectrum disorders. Dev Psychol. 2014 Mar;50(3):699-708. doi: 10.1037/a0034297. Epub 2013 Sep 2.
Reference Type
BACKGROUND
Hume K, Loftin R, Lantz J. Increasing independence in autism spectrum disorders: a review of three focused interventions. J Autism Dev Disord. 2009 Sep;39(9):1329-38. doi: 10.1007/s10803-009-0751-2. Epub 2009 May 9.
Reference Type
BACKGROUND
Hill EL. Executive dysfunction in autism. Trends Cogn Sci. 2004 Jan;8(1):26-32. doi: 10.1016/j.tics.2003.11.003.
Reference Type
BACKGROUND
Pugliese CE, Anthony L, Strang JF, Dudley K, Wallace GL, Kenworthy L. Increasing adaptive behavior skill deficits from childhood to adolescence in autism spectrum disorder: role of executive function. J Autism Dev Disord. 2015 Jun;45(6):1579-87. doi: 10.1007/s10803-014-2309-1.
Reference Type
BACKGROUND
Kenworthy L, Anthony LG, Naiman DQ, Cannon L, Wills MC, Luong-Tran C, Werner MA, Alexander KC, Strang J, Bal E, Sokoloff JL, Wallace GL. Randomized controlled effectiveness trial of executive function intervention for children on the autism spectrum. J Child Psychol Psychiatry. 2014 Apr;55(4):374-83. doi: 10.1111/jcpp.12161. Epub 2013 Nov 21.
Reference Type
BACKGROUND
Taylor JL, Dove D, Veenstra-VanderWeele J, et al. Comparative Effictiveness Review: Interventions for Adolescents and Young Adults With Autism. 2012;(65).
Reference Type
BACKGROUND
Dingfelder HE, Mandell DS. Bridging the research-to-practice gap in autism intervention: an application of diffusion of innovation theory. J Autism Dev Disord. 2011 May;41(5):597-609. doi: 10.1007/s10803-010-1081-0.
Reference Type
BACKGROUND
Kenworthy L, Black DO, Harrison B, della Rosa A, Wallace GL. Are executive control functions related to autism symptoms in high-functioning children? Child Neuropsychol. 2009 Sep;15(5):425-40. doi: 10.1080/09297040802646983.
Reference Type
BACKGROUND
Solomon M, Ozonoff SJ, Ursu S, Ravizza S, Cummings N, Ly S, Carter CS. The neural substrates of cognitive control deficits in autism spectrum disorders. Neuropsychologia. 2009 Oct;47(12):2515-26. doi: 10.1016/j.neuropsychologia.2009.04.019. Epub 2009 May 4.
Reference Type
BACKGROUND
Shafritz KM, Dichter GS, Baranek GT, Belger A. The neural circuitry mediating shifts in behavioral response and cognitive set in autism. Biol Psychiatry. 2008 May 15;63(10):974-80. doi: 10.1016/j.biopsych.2007.06.028. Epub 2007 Oct 4.
Reference Type
BACKGROUND
Vaidya CJ, Gordon EM. Phenotypic variability in resting-state functional connectivity: current status. Brain Connect. 2013;3(2):99-120. doi: 10.1089/brain.2012.0110.
Reference Type
BACKGROUND
Autism and Developmental Disabilities Monitoring Network Surveillance Year 2008 Principal Investigators; Centers for Disease Control and Prevention. Prevalence of autism spectrum disorders--Autism and Developmental Disabilities Monitoring Network, 14 sites, United States, 2008. MMWR Surveill Summ. 2012 Mar 30;61(3):1-19.
Reference Type
BACKGROUND
Cidav Z, Lawer L, Marcus SC, Mandell DS. Age-related variation in health service use and associated expenditures among children with autism. J Autism Dev Disord. 2013 Apr;43(4):924-31. doi: 10.1007/s10803-012-1637-2.
Reference Type
BACKGROUND
Shattuck PT, Narendorf SC, Cooper B, Sterzing PR, Wagner M, Taylor JL. Postsecondary education and employment among youth with an autism spectrum disorder. Pediatrics. 2012 Jun;129(6):1042-9. doi: 10.1542/peds.2011-2864. Epub 2012 May 14.
Reference Type
BACKGROUND
Taylor JL, Henninger NA. Frequency and correlates of service access among youth with autism transitioning to adulthood. J Autism Dev Disord. 2015 Jan;45(1):179-91. doi: 10.1007/s10803-014-2203-x.
Reference Type
BACKGROUND
Taylor JL, Henninger NA, Mailick MR. Longitudinal patterns of employment and postsecondary education for adults with autism and average-range IQ. Autism. 2015 Oct;19(7):785-93. doi: 10.1177/1362361315585643. Epub 2015 May 27.
Reference Type
BACKGROUND
Geurts HM, Verte S, Oosterlaan J, Roeyers H, Sergeant JA. How specific are executive functioning deficits in attention deficit hyperactivity disorder and autism? J Child Psychol Psychiatry. 2004 May;45(4):836-54. doi: 10.1111/j.1469-7610.2004.00276.x.
Reference Type
BACKGROUND
Hughes C, Russell J, Robbins TW. Evidence for executive dysfunction in autism. Neuropsychologia. 1994 Apr;32(4):477-92. doi: 10.1016/0028-3932(94)90092-2.
Reference Type
BACKGROUND
Ozonoff S, Pennington BF, Rogers SJ. Executive function deficits in high-functioning autistic individuals: relationship to theory of mind. J Child Psychol Psychiatry. 1991 Nov;32(7):1081-105. doi: 10.1111/j.1469-7610.1991.tb00351.x.
Reference Type
BACKGROUND
Ozonoff S, Jensen J. Brief report: specific executive function profiles in three neurodevelopmental disorders. J Autism Dev Disord. 1999 Apr;29(2):171-7. doi: 10.1023/a:1023052913110. No abstract available.
Reference Type
BACKGROUND
Kenworthy L, Yerys BE, Anthony LG, Wallace GL. Understanding executive control in autism spectrum disorders in the lab and in the real world. Neuropsychol Rev. 2008 Dec;18(4):320-38. doi: 10.1007/s11065-008-9077-7. Epub 2008 Oct 28.
Reference Type
BACKGROUND
Lopata C et al. ABAS-II Ratings and Correlates of Adaptive Behavior in Children with HFASDs. J Dev Phys Disabil. 2012;24:391-402.
Reference Type
BACKGROUND
Lawson RA, Papadakis AA, Higginson CI, Barnett JE, Wills MC, Strang JF, Wallace GL, Kenworthy L. Everyday executive function impairments predict comorbid psychopathology in autism spectrum and attention deficit hyperactivity disorders. Neuropsychology. 2015 May;29(3):445-53. doi: 10.1037/neu0000145. Epub 2014 Oct 13.
Reference Type
BACKGROUND
Lounds J, Seltzer MM, Greenberg JS, Shattuck PT. Transition and change in adolescents and young adults with autism: longitudinal effects on maternal well-being. Am J Ment Retard. 2007 Nov;112(6):401-17. doi: 10.1352/0895-8017(2007)112[401:TACIAA]2.0.CO;2.
Reference Type
BACKGROUND
Shattuck PT, Steinberg J, Yu J, Wei X, Cooper BP, Newman L, Roux AM. Disability Identification and Self-Efficacy among College Students on the Autism Spectrum. Autism Res Treat. 2014;2014:924182. doi: 10.1155/2014/924182. Epub 2014 Feb 23.
Reference Type
BACKGROUND
Weisz JR, Ugueto AM, Cheron DM, Herren J. Evidence-based youth psychotherapy in the mental health ecosystem. J Clin Child Adolesc Psychol. 2013;42(2):274-86. doi: 10.1080/15374416.2013.764824. Epub 2013 Feb 12.
Reference Type
BACKGROUND
Ylvisaker M, Jacobs HE, Feeney T. Positive supports for people who experience behavioral and cognitive disability after brain injury: a review. J Head Trauma Rehabil. 2003 Jan-Feb;18(1):7-32. doi: 10.1097/00001199-200301000-00005.
Reference Type
BACKGROUND
Oberman L, Pascual-Leone A. Changes in plasticity across the lifespan: cause of disease and target for intervention. Prog Brain Res. 2013;207:91-120. doi: 10.1016/B978-0-444-63327-9.00016-3.
Reference Type
BACKGROUND
Lee PS, Yerys BE, Della Rosa A, Foss-Feig J, Barnes KA, James JD, VanMeter J, Vaidya CJ, Gaillard WD, Kenworthy LE. Functional connectivity of the inferior frontal cortex changes with age in children with autism spectrum disorders: a fcMRI study of response inhibition. Cereb Cortex. 2009 Aug;19(8):1787-94. doi: 10.1093/cercor/bhn209. Epub 2008 Dec 9.
Reference Type
BACKGROUND
Huttenlocher PR. Morphometric study of human cerebral cortex development. Neuropsychologia. 1990;28(6):517-27. doi: 10.1016/0028-3932(90)90031-i.
Reference Type
BACKGROUND
Giedd JN, Blumenthal J, Jeffries NO, Castellanos FX, Liu H, Zijdenbos A, Paus T, Evans AC, Rapoport JL. Brain development during childhood and adolescence: a longitudinal MRI study. Nat Neurosci. 1999 Oct;2(10):861-3. doi: 10.1038/13158. No abstract available.
Reference Type
BACKGROUND
Gogtay N, Giedd JN, Lusk L, Hayashi KM, Greenstein D, Vaituzis AC, Nugent TF 3rd, Herman DH, Clasen LS, Toga AW, Rapoport JL, Thompson PM. Dynamic mapping of human cortical development during childhood through early adulthood. Proc Natl Acad Sci U S A. 2004 May 25;101(21):8174-9. doi: 10.1073/pnas.0402680101. Epub 2004 May 17.
Reference Type
BACKGROUND
Shonkoff JP. Protecting brains, not simply stimulating minds. Science. 2011 Aug 19;333(6045):982-3. doi: 10.1126/science.1206014.
Reference Type
BACKGROUND
Yerys BE, Antezana L, Weinblatt R, Jankowski KF, Strang J, Vaidya CJ, Schultz RT, Gaillard WD, Kenworthy L. Neural Correlates of Set-Shifting in Children With Autism. Autism Res. 2015 Aug;8(4):386-97. doi: 10.1002/aur.1454. Epub 2015 Jan 20.
Reference Type
BACKGROUND
Castellanos FX, Margulies DS, Kelly C, Uddin LQ, Ghaffari M, Kirsch A, Shaw D, Shehzad Z, Di Martino A, Biswal B, Sonuga-Barke EJ, Rotrosen J, Adler LA, Milham MP. Cingulate-precuneus interactions: a new locus of dysfunction in adult attention-deficit/hyperactivity disorder. Biol Psychiatry. 2008 Feb 1;63(3):332-7. doi: 10.1016/j.biopsych.2007.06.025. Epub 2007 Sep 21.
Reference Type
BACKGROUND
Assaf M, Jagannathan K, Calhoun VD, Miller L, Stevens MC, Sahl R, O'Boyle JG, Schultz RT, Pearlson GD. Abnormal functional connectivity of default mode sub-networks in autism spectrum disorder patients. Neuroimage. 2010 Oct 15;53(1):247-56. doi: 10.1016/j.neuroimage.2010.05.067. Epub 2010 Jun 2.
Reference Type
BACKGROUND
Doyle-Thomas KA, Lee W, Foster NE, Tryfon A, Ouimet T, Hyde KL, Evans AC, Lewis J, Zwaigenbaum L, Anagnostou E; NeuroDevNet ASD Imaging Group. Atypical functional brain connectivity during rest in autism spectrum disorders. Ann Neurol. 2015 May;77(5):866-76. doi: 10.1002/ana.24391. Epub 2015 Mar 27.
Reference Type
BACKGROUND
Eilam-Stock T, Xu P, Cao M, Gu X, Van Dam NT, Anagnostou E, Kolevzon A, Soorya L, Park Y, Siller M, He Y, Hof PR, Fan J. Abnormal autonomic and associated brain activities during rest in autism spectrum disorder. Brain. 2014 Jan;137(Pt 1):153-71. doi: 10.1093/brain/awt294.
Reference Type
BACKGROUND
Jung M, Kosaka H, Saito DN, Ishitobi M, Morita T, Inohara K, Asano M, Arai S, Munesue T, Tomoda A, Wada Y, Sadato N, Okazawa H, Iidaka T. Default mode network in young male adults with autism spectrum disorder: relationship with autism spectrum traits. Mol Autism. 2014 Jun 11;5:35. doi: 10.1186/2040-2392-5-35. eCollection 2014.
Reference Type
BACKGROUND
Monk CS, Peltier SJ, Wiggins JL, Weng SJ, Carrasco M, Risi S, Lord C. Abnormalities of intrinsic functional connectivity in autism spectrum disorders. Neuroimage. 2009 Aug 15;47(2):764-72. doi: 10.1016/j.neuroimage.2009.04.069. Epub 2009 May 3.
Reference Type
BACKGROUND
Yerys BE, Gordon EM, Abrams DN, Satterthwaite TD, Weinblatt R, Jankowski KF, Strang J, Kenworthy L, Gaillard WD, Vaidya CJ. Default mode network segregation and social deficits in autism spectrum disorder: Evidence from non-medicated children. Neuroimage Clin. 2015 Aug 18;9:223-32. doi: 10.1016/j.nicl.2015.07.018. eCollection 2015.
Reference Type
BACKGROUND
Kennedy DP, Redcay E, Courchesne E. Failing to deactivate: resting functional abnormalities in autism. Proc Natl Acad Sci U S A. 2006 May 23;103(21):8275-80. doi: 10.1073/pnas.0600674103. Epub 2006 May 15.
Reference Type
BACKGROUND
Dawson G, Jones EJ, Merkle K, Venema K, Lowy R, Faja S, Kamara D, Murias M, Greenson J, Winter J, Smith M, Rogers SJ, Webb SJ. Early behavioral intervention is associated with normalized brain activity in young children with autism. J Am Acad Child Adolesc Psychiatry. 2012 Nov;51(11):1150-9. doi: 10.1016/j.jaac.2012.08.018.
Reference Type
BACKGROUND
Gordon I, Vander Wyk BC, Bennett RH, Cordeaux C, Lucas MV, Eilbott JA, Zagoory-Sharon O, Leckman JF, Feldman R, Pelphrey KA. Oxytocin enhances brain function in children with autism. Proc Natl Acad Sci U S A. 2013 Dec 24;110(52):20953-8. doi: 10.1073/pnas.1312857110. Epub 2013 Dec 2.
Reference Type
BACKGROUND
Voos AC, Pelphrey KA, Tirrell J, Bolling DZ, Vander Wyk B, Kaiser MD, McPartland JC, Volkmar FR, Ventola P. Neural mechanisms of improvements in social motivation after pivotal response treatment: two case studies. J Autism Dev Disord. 2013 Jan;43(1):1-10. doi: 10.1007/s10803-012-1683-9.
Reference Type
BACKGROUND
Walker HM. Use of evidence-based interventions in schools: where we've been, where we are, and where we need to go. School Psych Rev. 2004;33:398-407.
Reference Type
BACKGROUND
Kasari C, Lawton K. New directions in behavioral treatment of autism spectrum disorders. Curr Opin Neurol. 2010 Apr;23(2):137-43. doi: 10.1097/WCO.0b013e32833775cd.
Reference Type
BACKGROUND
Pugliese CE, Anthony LG, Strang JF, Dudley K, Wallace GL, Naiman DQ, Kenworthy L. Longitudinal Examination of Adaptive Behavior in Autism Spectrum Disorders: Influence of Executive Function. J Autism Dev Disord. 2016 Feb;46(2):467-77. doi: 10.1007/s10803-015-2584-5.
Reference Type
BACKGROUND
J J, HA L, CK W. Subjective culture and social behavior. In: Adamopoulos J, Kashima Y, eds. Social Psychology and Cultural Context. Thousand Oaks, CA: Sage Publications; 1999:95-106.
Reference Type
BACKGROUND
Wallace GL, Silvers JA, Martin A, Kenworthy LE. Brief report: Further evidence for inner speech deficits in autism spectrum disorders. J Autism Dev Disord. 2009 Dec;39(12):1735-9. doi: 10.1007/s10803-009-0802-8. Epub 2009 Jun 30.
Reference Type
BACKGROUND
Wechsler D, Zhou X. Wechsler Abbreviated Scale of Intelligence II. NY, New York: The Psychological Corporation: Harcourt Brace & Company; 2011.
Reference Type
BACKGROUND
Lord C, Rutter M, DiLavore PC, Risi S, Gotham K, Bishop SL. Autism Diagnostic Observation Schedule, 2nd Ed. (ADOS-2). Torrance, CA: Western Psychological Services; 2012.
Reference Type
BACKGROUND
Rutter M, Bailey A, Berument SK, Le Couteur A, Lord C. Social Communication Questionnaire (SCQ) Manual. Los Angeles, CA: Western Psychological Services; 2003.
Reference Type
BACKGROUND
Gioia G, Isquith P, Guy S, Kenworthy L. BRIEF: Behavior Rating Inventory of Executive Function. Odessa: Psychological Assessment Resources; 2000.
Reference Type
BACKGROUND
Sparrow S, Cicchetti D, Balla DA. Vineland Adaptive Behavior Scales Second Edition:Survey Forms Manual. Minneapolis, MN: Pearson; 2005.
Reference Type
BACKGROUND
Abraha I, Montedori A. Modified intention to treat reporting in randomised controlled trials: systematic review. BMJ. 2010 Jun 14;340:c2697. doi: 10.1136/bmj.c2697.
Reference Type
BACKGROUND
Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.
Reference Type
BACKGROUND
Clopper CJ, Pearson ES. The Use of Confidence or Fiducial Limits Illustrated in the Case of the Binomial. Biometrika. 1934;26:404-413.
Reference Type
BACKGROUND
MATLAB Version 7.10.0. Natick, Massachusettes: The MathWorks Inc.; 2010.
Reference Type
BACKGROUND
IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corporation; 2013.
Reference Type
BACKGROUND
Bullmore E, Sporns O. Complex brain networks: graph theoretical analysis of structural and functional systems. Nat Rev Neurosci. 2009 Mar;10(3):186-98. doi: 10.1038/nrn2575. Epub 2009 Feb 4.
Reference Type
BACKGROUND
Rubinov M, Sporns O. Complex network measures of brain connectivity: uses and interpretations. Neuroimage. 2010 Sep;52(3):1059-69. doi: 10.1016/j.neuroimage.2009.10.003. Epub 2009 Oct 9.
Reference Type
BACKGROUND
Power JD, Cohen AL, Nelson SM, Wig GS, Barnes KA, Church JA, Vogel AC, Laumann TO, Miezin FM, Schlaggar BL, Petersen SE. Functional network organization of the human brain. Neuron. 2011 Nov 17;72(4):665-78. doi: 10.1016/j.neuron.2011.09.006.
Reference Type
BACKGROUND
Benjamini Y, Hochberg Y. Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing. J R Stat Soc. 1995;57(1):289-300.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
OAR Innovative Research Award
Identifier Type: OTHER
Identifier Source: secondary_id
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