NCT03003286|Completed
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Sponsor study identifier
interventional
148
1 country
1
Study Start
September 13, 2014
Actual (reported)Primary Completion
August 5, 2017
Actual (reported)Study Completion
August 5, 2017
Actual (reported)The purpose of this study is to determine whether a new treatment, Unstuck and On Target (UOT), works better, worse, or the same as the best treatment that is available now, Contingency Behavioral Management (CBM), for low income children with Autism Spectrum Disorder (ASD) or Attention Deficit Hyperactivity Disorder (ADHD).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 5, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 13, 2014
Actual (reported)November 21, 2016
Actual (reported)December 28, 2016
Actual (reported)August 5, 2017
Actual (reported)August 5, 2017
Actual (reported)Change in Classroom Observation total raw score at termination of intervention
15-20 minute classroom observation conducted by a treatment-blind research assistant for every study participant during the academic school day. The following behaviors are coded: Social reciprocity, Following Rules, Transitions, Gets Stuck, Negativity/Overwhelm, and Classroom Participation.
Baseline, 7-8 months
Change in Wechsler Abbreviated Scale of Intelligence--II Block Design- T-score at termination of intervention (post testing) and 1 year later (long-term follow-up)
Baseline, 7-8 months, 19-20 months
Change in Delis-Kaplan Executive Function System - Category Fluency and Switching Accuracy scaled scores at termination of intervention (post testing) and 1 year later (long-term follow-up)
Unstuck and on Target (UOT) provided in the classroom for students at Title 1 schools
Parents and Teachers Supporting Students (PATSS) provided in the classroom for students at Title 1 schools
Unstuck and on Target (UOT) is a novel and innovative cognitive-behavioral treatment that directly addresses executive functioning and self-regulation deficits in ASD and ADHD. UOT is the first contextually-based EF treatment that targets flexibility, goal-setting and planning through a cognitive-behavioral program centered on self-regulatory scripts that are consistently modeled and reinforced. Parents, teachers, and interventionists will be taught to model and support flexibility across settings. Children will also participate in a peer group intervention setting.
Children's Research Institude, Children's National Heath System
Washington D.C., District of Columbia, 20010, United States
American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 4th Edition, Text Revision. 2000.
Clopper CJ, Pearson, ES. The use of the confidence or fiducial limits illustrated in the case of the binomial. Biometrika 26(4): 404-413, 1934.
Delis DC, Kaplan E, Kramer JH. Delis Kaplan executive function system (D-KEFS). San Antonio, TX: The Psychological Corporation. 2001.
Gioia GA, Isquith PK, Kenworthy L, Barton RM. Profiles of everyday executive function in acquired and developmental disorders. Child Neuropsychol. 2002 Jun;8(2):121-37. doi: 10.1076/chin.8.2.121.8727.
Lauren Kenworthy, Ph.D.
Children's National Health Services
Laura Anthony, Ph.D.
University of Colorado, Denver
148 participants (actual enrollment reported by the registry).
First Submitted
November 21, 2016
First Posted
December 28, 2016
Study Start
September 13, 2014
Actual (reported)Baseline, 7-8 months,19-20 months
Change in Executive Function Challenge Task - Flexibility and Planning raw scores at termination of intervention (post testing) and 1 year later (long-term follow-up)
Baseline, 7-8 months, 19-20 months
Change in Flexibility Interference Questions Questionnaire total raw score at termination of intervention (post testing) and 1 year later (long-term follow-up)
Baseline, 7-8 months, 19-20 months
Change in Behavior Rating Inventory of Executive Function (BRIEF) - Parent Form - Shift, Plan/Organize, Emotional Control and Global Executive at termination of intervention (post testing) and 1 year later (long-term follow-up)Composite T-scores
Baseline, 7-8 months, 19-20 months
The Contingency Behavior Management (CBM) intervention was developed by the researchers and called Parents and Teachers Supporting Students (PATSS) as a current best practice intervention that was comparable in design to Unstuck and on Target. The goal is to improve child behavioral outcomes by training parents, teachers and interventionists in core principles of behavior management like social learning and behavioral change. Children were also included in small group sessions where they identify their own behavior goals and meaningful reinforcers.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Gioia GA, Isquith PK, Retzlaff PD, Espy KA. Confirmatory factor analysis of the Behavior Rating Inventory of Executive Function (BRIEF) in a clinical sample. Child Neuropsychol. 2002 Dec;8(4):249-57. doi: 10.1076/chin.8.4.249.13513.
Mather N, Wendling BJ. Woodcock-Johnson IV tests of achievement: Examiner manual standard and extended batteries. Rolling Meadows, IL: Houghton Mifflin Harcourt. 2014.
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.
Wells KC, Pelham WE, Kotkin RA, Hoza B, Abikoff HB, Abramowitz A, Arnold LE, Cantwell DP, Conners CK, Del Carmen R, Elliott G, Greenhill LL, Hechtman L, Hibbs E, Hinshaw SP, Jensen PS, March JS, Swanson JM, Schiller E. Psychosocial treatment strategies in the MTA study: rationale, methods, and critical issues in design and implementation. J Abnorm Child Psychol. 2000 Dec;28(6):483-505. doi: 10.1023/a:1005174913412.
Anthony LG, Kenworthy L, Verbalis A, Safer-Lichtenstein J, Hardy KK, Ratto AB, Pugliese C, Strang JF, Myrick Y, Seese S, Cannon L, Werner MA, Alexander K, Naiman DQ, Troxel M, Dahlman T, Anthony BJ, Mikulich-Gilbertson SK. Addressing Disparities: A Pragmatic Comparative Effectiveness Trial of School-Based Executive Functioning Interventions. Evid Based Pract Child Adolesc Ment Health. 2026 Feb 26:10.1080/23794925.2026.2633981. doi: 10.1080/23794925.2026.2633981. Online ahead of print.
Primary Completion
August 5, 2017
Actual (reported)Study Completion
August 5, 2017
Actual (reported)Last Updated
April 4, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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