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Executive Function Intervention for High School Students With ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03199937
Recruitment Status : Enrolling by invitation
First Posted : June 27, 2017
Last Update Posted : February 1, 2019
Sponsor:
Collaborator:
Georgetown University
Information provided by (Responsible Party):
Cara Pugliese, Children's Research Institute

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Flexible Futures Other: Current standard of care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Behavioral and Neural Outcomes of a New Executive Function Treatment for Transition-age Youth With ASD
Actual Study Start Date : July 11, 2015
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: 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.

Active Comparator: Waitlist control group
Current standard of care
Other: 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.




Primary Outcome Measures :
  1. Change in Behavior Rating Inventory of Executive Function (BRIEF)- Self-Report Form (Gioia, Isquith, Guy & Kenworthy, 2000). [ Time Frame: On average, 8 and 13 months ]

    This self-report measure has 55 items with seven clinical scales and three validity scales. It is normed for adolescents between 11 and 18 years of age. Items were developed to capture everyday behaviors associated with EF and tap seven domains: Inhibit, Self-Monitor, shift, Emotional Control, Task Completion, Working Memory, and Plan/Organize. The BRIEF is standardized with normative data expressed as T scores (mean=50; SD=10). Internal consistency is high, with index coefficients in the mid .90s to high .90s, while test-retest stability coefficients for the clinical scales ranged from .67-.79 within the standardization subsample. The individual scales and summary indexes were correlated in various clinical samples with other measures of attentional and behavioral functioning (Behavior Assessment Scales for Children, Child Behavior Checklist, ADHD-RS-IV, Conners 3), providing evidence of convergent and divergent validity.

    Safety Issue: No


  2. Change in Challenge Task (CT) scores [ Time Frame: On average, 8 and 13 months ]

    The Challenge Task is an unpublished, un-normed measure designed by the study staff to measure flexibility and planning in a social context with standardized tasks (Anthony & Kenworthy, 2012). It is a 20-minute play interview that challenges children to be flexible and planful in the context of three activities with an examiner. Specific challenges are posed, and the child's flexibility and planning are scored on a 3-point scale for each task. The scale has task-specific behavioral markers to guide. The CT yields average Flexibility and Planning scores (higher scores indicate greater impairment). Reliability observations will be completed with a second coder for 25% of the videotapes. Examiners in a previous trial achieved interrater agreement >90%, and we will maintain that same standard for the current project.

    Safety Issue: No


  3. Change in Wechsler Abbreviated Scale of Intelligence- Second Edition (WASI-II, Wechsler, 2011), block design subtest [ Time Frame: On average, 8 and 13 months ]

    The WASI-II is an estimate of intelligence, comprised of four subtests, which takes 30-45 minutes to administer. It is a well-standardized task with normative data for ages 6-90. Subtests include the Block Design subtest, the Similarities subtest, the Matrix Reasoning subtest, and the Vocabulary subtest. Performance on each subtest is represented as a T score (mean=50; SD=10), with higher scores indicating better performance. Overall IQ is calculated from a composite of all four subtests and is represented as a standard score (mean=100; SD=15). The entire WASI-2 will be completed at the Baseline Evaluation to identify full-scale IQ and verbal age (based on the vocabulary subtest). Subsequently, the Block Design subtest only will be completed at the Post-Treatment and Long-term Follow-up Evaluations.

    Safety Issue: No


  4. Change in Delis-Kaplan Executive Functioning System (DKEFS; Delis, Kaplan, and Kramer, 2001), Sorting subtest [ Time Frame: On average, 8 and 13 months ]

    The DKEFS is a standardized measure of executive functioning skills and in normed for ages eight through adulthood. The Sorting Subtest particularly measures flexibility. The DKEFS will be completed both at the Baseline and, the Post-Intervention Evaluation as measure of outcome. It takes approximately 10 minutes to administer, and although specific data were not available, the measure has been well documented across several neuropsychological studies to have evidence of reliability and validity.

    Safety Issue: No


  5. Change in Tower of London-Drexel (TOL-DX; Culbertson & Zillmer, 2000) scores [ Time Frame: On average, 8 and 13 months ]

    TOL-DX measures multiple EFs such as planning, inhibition, and working memory. It requires the subject to work step-by-step to copy a pattern of beads on pegs using the least number of moves possible. The total-moves score will be measured as an omnibus measure of EF. Results are reported as standard scores (M = 100; SD = 15).

    Safety Issue: No


  6. Change in Adaptive Behavior Assessment System—Second Edition (ABAS-2) [ Time Frame: On average, 8 and 13 months ]

    (ABAS-II; Harrison and Oakland 2003) is a measure of adaptive behavior with national standardization samples representative of the English speaking US population. The informant report adult form of the ABAS-2(Harrison and Oakland 2003) used in the present study was standardized on an age stratified sample and provided information in the areas of Conceptual (including Communication, Functional Academics, Self-Direction), Social (including not only Social but also Leisure), and Practical (including Community Use, Home Living, Health and Safety, Self-Care) Skills, all of which are presented as norm-referenced standard scores (M = 100; SD = 15) and were used as correlates of interest in the present study.

    Safety Issue: No


  7. Social Responsiveness Scale—Second Edition (SRS-2; Constantino and Gruber 2012) [ Time Frame: On average, 8 and 13 months ]

    The SRS-2 is a 65-item informant report of autistic traits rated on a 4-point Likert Scale (0-3 points). Higher scores indicate more autistic traits; T-scores ≥ 65 (i.e., 1.5 SDs ≥ the population mean of 50) suggest clinically significant autistic traits. The SRS-2 scoring is aligned with DSM-5 criteria for diagnosis of an ASD. The update includes the creation of two higher order indices that correspond to the two symptom domains of ASD: Social Communication and Interaction (SCI) and Restricted Interests and Repetitive Behavior (RRB). Informants provided a single SRS-2 rating for each child in this study. The SRS-2 will be completed at Baseline and Post-Intervention testing.

    Safety Issue: No


  8. Change in Behavior Rating Inventory of Executive Function, Second Edition (BRIEF-2)- Parent Form (Gioia, Isquith, Guy & Kenworthy, 2015). [ Time Frame: On average, 8 and 13 months ]
    This parent-report measure contains 63 items with nine clinical scales and three validity scales. It is normed for children ages 5-18. Items were developed to capture everyday behaviors associated with EF and tap nine domains including: Inhibit, Self-Monitor, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task-Monitor, and Organization of Materials. It is a standardized questionnaire with normative data and standardized scores expressed as T scores (mean=50; SD=10). Internal consistency is high, with index coefficients above .90, while test-retest stability coefficients for the clinical scales ranged from .67-.92 within the parent standardization subsample. The individual scales and summary indexes of the BRIEF-2 were correlated in various clinical samples with other measures of attentional and behavioral functioning (BASC, CBCL, ADHD-RS-IV, Conners 3), which collectively provided evidence of convergent and divergent validity. Safety Issue: No

  9. Flexibility and Planning Interference Scale [ Time Frame: On average, 8 and 13 months ]
    To meet the needs of the current study by addressing the issue of flexibility more specifically, we will modify the BRIEF to include 14 additional unpublished, unnormed "Flexibility" and "Interference" items. These items will assess how much flexibility impacts the child's and family's life. The items will use a 0-3 scale (0-No Interference, 1-Mildly interfering , 2-Moderately Interfering, 3- Severely Interfering) and will ask about behavior observed during the past two weeks (example: "How much do difficulties with flexibility interfere with or disrupt everyday activities (self-care, school, etc.?)") Safety Issue: No

  10. The Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP, Swanson, 1992) [ Time Frame: On average, 8 and 13 months ]

    The SKAMP is a teacher rating scale that takes 5 minutes to complete and assesses impairment from classroom behaviors associated with executive function in adolescents. Although our study uses a modified form of the SKAMP for which reliability and validity data are unavailable, previous community-based trials of the SKAMP showed evidence of high internal consistency, with reliabilities of .98 for overall SKAMP scores, .96 for Deportment (Behavior), and .95 for Attention. The SKAMP was found to be strongly correlated to both parent and teacher versions of the Swanson, Nolan, and Pelham-IV (SNAP-IV; r = .93 and .79 for Inattention and Hyperactivity/Impulsivity). Teachers rate the severity of 10 common behaviors on a 4-point scale, including 6 items related to attention and 4 items related to problematic behavior.

    Safety Issue: No


  11. Classroom Observations [ Time Frame: On average, 8 and 13 months ]

    To further assess functional improvement, at least two 15-minute classroom observations will be conducted by an intervention-blind research assistant (who has achieved reliability on coding criteria) for every study participant. They will occur randomly during the academic school day, but not during Flexible Futures small group sessions or Social Skills training. The following behaviors will be coded for children in this study: Reciprocity, Following Rules, Transitions, Gets Stuck, Negativity/Overwhelm, and Classroom Participation. During the classroom observations, the following behaviors will be coded for the teacher's behavior: Flexibility, Planning/Organizing, Provides Clear Instructions/ Expectations, Actively Uses Visual Support, References Classroom Rules, Maintains Positive Praise: Command/Correction ratio and Uses Reward System.

    Safety Issue: No


  12. Cognitive Flexibility Task [ Time Frame: On average, 8 and 13 months ]

    A task-based fMRI procedure will be used to detect pre-to-post treatment change. Participants will classify pairs of stimuli (objects and pictures) on the basis of how well they "go together" and respond with an appropriate button press. The specific task may change based on pilot results but will be similar to what is proposed.

    Safety Issue: No




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Ages Eligible for Study:   14 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199937


Locations
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United States, District of Columbia
Children's Research Institute
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's Research Institute
Georgetown University
Investigators
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Principal Investigator: Cara E Pugliese, Ph.D. Children's Research Institute

Publications:
Interagency Autism Coordinating Committee. The 2011 Interagency Autism Coordinating Committee Strategic Plan for Autism Spectrum Disorder Research.; 2011.
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.
Lopata C et al. ABAS-II Ratings and Correlates of Adaptive Behavior in Children with HFASDs. J Dev Phys Disabil. 2012;24:391-402.
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.
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.
Wechsler D, Zhou X. Wechsler Abbreviated Scale of Intelligence II. NY, New York: The Psychological Corporation: Harcourt Brace & Company; 2011.
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.
Rutter M, Bailey A, Berument SK, Le Couteur A, Lord C. Social Communication Questionnaire (SCQ) Manual. Los Angeles, CA: Western Psychological Services; 2003.
Gioia G, Isquith P, Guy S, Kenworthy L. BRIEF: Behavior Rating Inventory of Executive Function. Odessa: Psychological Assessment Resources; 2000.
Sparrow S, Cicchetti D, Balla DA. Vineland Adaptive Behavior Scales Second Edition:Survey Forms Manual. Minneapolis, MN: Pearson; 2005.
Clopper CJ, Pearson ES. The Use of Confidence or Fiducial Limits Illustrated in the Case of the Binomial. Biometrika. 1934;26:404-413.
MATLAB Version 7.10.0. Natick, Massachusettes: The MathWorks Inc.; 2010.
IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corporation; 2013.
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.

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Responsible Party: Cara Pugliese, Principal Investigator, Children's Research Institute
ClinicalTrials.gov Identifier: NCT03199937     History of Changes
Other Study ID Numbers: 1K23MH110612-01 ( U.S. NIH Grant/Contract )
OAR Innovative Research Award ( Other Identifier: Organization for Autism Research )
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cara Pugliese, Children's Research Institute:
Autism Spectrum Disorder
Executive Functioning
Intervention
Flexible
Unstuck
Transition
Behavior
High school
Problem Solving
Self-Control
Coping
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders