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Reading Remediation and Outcomes in Detention (SERIOUS)

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ClinicalTrials.gov Identifier: NCT03261076
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
University of Houston
Harris County Juvenile Probation Department (HCJPD)
Connecticut Court Support Services Division (CSSD)
MindTrust Labs, LLC
Information provided by (Responsible Party):
Elena, Baylor College of Medicine

Brief Summary:
The current literature on academic skill difficulties, whether considered as part of the continuum of ability or as a specific learning disability (LD), indicates that these problems often coexist with conduct problems and juvenile delinquency, and are risk factors for initial law-breaking behavior and for its persistence. However, less is understood about how this relationship develops. It is these broad questions that this project seeks to address. First, what is the causal pathway? Does LD cause delinquency, delinquency cause LD, or are both caused by something else? And can big data analytics applied to statewide datasets of information about juvenile justice (JJ) involvement help to answer this question? Second, as it is known that learning to read and do math (and thus becoming more employable) increases the likelihood of desistance (i.e., not committing any more illegal acts), what are the necessary parts of an intervention designed to teach these skills? And what role might technology play in such an intervention? To answer these questions, we will implement a study that includes two components, (a) a big data component and (b) an intervention component. For (a), we will work with a large historical dataset from the Harris County Juvenile Probation Department. For (b), we will work, in total, with 192 (48 per year) delinquent youth with severe LD in residential placement. These individuals, in a nonconcurrent multiple baseline design, will be offered an educational therapy designed to address severe reading problems in juvenile detainees using a novel mixed media intervention in which the person-to-person intensive 1:1 component is completed while youth are in residential settings (24 sessions, delivered in 90 minute settings 3 times a week) and a "gamified" educational smartphone learning tool follow-up completed upon release (with appropriate network fidelity monitoring and participant reinforcement). The person-to-person component is developed specifically for juvenile offenders with severe LD, combining two well-established and highly-regarded intervention programs designed to systematically build students' repertoire of grapheme-phoneme correspondence rules as well as develop comprehensive reading skills, from beginning reading to proficiency.

Condition or disease Intervention/treatment Phase
Specific Learning Disorder (MeSH Unique ID: D000067559) Dyslexia (MeSH Unique ID: D004410) Conduct Disorder (MeSH Unique ID: D019955) Behavioral: Strategies Enhancing Reading in Older Underperf. Students Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This study uses a multiple baseline design, in which participants enter into the single-arm intervention at different times, yet have data collected at all time points. Approximately one third of participants will have their entry into the intervention shifted later by one week, and approximately another third will have their entry shifted by two weeks. This will happen on a rotating basis. All individuals will receive progress monitoring during the weeks that the other individuals are receiving intervention and/or assessments. The multiple baseline design allows for all individuals to receive the study intervention, and still provides a mechanism for monitoring change (or lack thereof) during non-intervention periods before and after intervention.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Severe LD in Juvenile Delinquents: Presentation, Course, and Remediation
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: SERIOUS Intervention
All youth will be juveniles in a residential facility for post-adjudicated youth. They will be recruited into the study as they are being placed in the facility post-adjudication, to ensure that they meet criteria and will be in the facility long enough to complete the program. All qualified youth will be invited to participate in the SERIOUS intervention; once a group of youth are recruited to complete the multiple baseline design and interventionists are free (from running interventions with other participants) to work with the youth, an intervention cycle will begin.
Behavioral: Strategies Enhancing Reading in Older Underperf. Students
Strategies for Enhancing Reading in Older Underperf. Students (SERIOUS) combines two scientific, research based intervention programs, each meeting specific need of youth in detention: (1) Stevenson Reading Program, manualized and uniquely suited to students with phonological awareness, attention, and memory difficulties that may impact reading; and (2) Dr. Sharon Vaughn's well-documented, validated program, explicitly designed for older, severely reading-impaired students. SERIOUS also includes: (3) metacognitive strategies for self-regulated learning, and (4) A gamified extension of the intervention on a SmartPhone, designed to reinforce word-level skills (e.g., decoding, automaticity, and vocabulary), and including features efficacious for learning.




Primary Outcome Measures :
  1. Change in Reading Skills from pre-intervention (baseline) to the week after intervention [ Time Frame: Assessment of change will take place at pre-intervention (baseline), the week before intervention, after four weeks of intervention, and the week after intervention. ]

    Reading skills will be measured as a composite of two subtests from the Kaufman Test of Educational Achievement, Third Edition (KTEA-3):

    1. Letter & Word Recognition
    2. Reading Comprehension

    This standard score will be obtained based on the sum of subtest standard scores according to published norms.


  2. Change in Decoding Skills from pre-intervention (baseline) to the week after intervention [ Time Frame: Assessment of change will take place at pre-intervention (baseline), the week before intervention, after four weeks of intervention, and the week after intervention. ]

    Decoding skills will be measured as a composite of two subtests from the Kaufman Test of Educational Achievement, Third Edition (KTEA-3):

    1. Letter & Word Recognition
    2. Nonsense Word Decoding

    This standard score will be obtained based on the sum of subtest standard scores according to published norms.


  3. Change in Reading Understanding from pre-intervention (baseline) to the week after intervention [ Time Frame: Assessment of change will take place at pre-intervention (baseline), the week before intervention, after four weeks of intervention, and the week after intervention. ]

    Reading understanding will be measured as a composite of two subtests from the Kaufman Test of Educational Achievement, Third Edition (KTEA-3):

    1. Reading Comprehension
    2. Reading Vocabulary

    This standard score will be obtained based on the sum of subtest standard scores according to published norms.


  4. Change in Comprehension from pre-intervention (baseline) to the week after intervention [ Time Frame: Assessment of change will take place at pre-intervention (baseline), the week before intervention, after four weeks of intervention, and the week after intervention. ]

    Comprehension will be measured as a composite of two subtests from the Kaufman Test of Educational Achievement, Third Edition (KTEA-3):

    1. Reading Comprehension
    2. Listening Comprehension

    This standard score will be obtained based on the sum of subtest standard scores according to published norms.


  5. Change in Reading Fluency from pre-intervention (baseline) to the week after intervention [ Time Frame: Assessment of change will take place at pre-intervention (baseline), the week before intervention, after four weeks of intervention, and the week after intervention. ]
    The Test of Reading Efficiency, Second Edition (TOWRE-2) will be used to measure an individual's ability to pronounce printed words and phonemically regular nonwords accurately and fluently. Standard scores will be obtained according to published norms.

  6. Change in Other Academic Skills from pre-intervention (baseline) to the week after intervention [ Time Frame: Assessment of change will take place at pre-intervention (baseline), the week before intervention, after four weeks of intervention, and the week after intervention. ]

    Other academic skills will be measured as a composite of remaining subtests from the Kaufman Test of Educational Achievement, Third Edition (KTEA-3) and Woodcock-Johnson-IV Tests of Academic Achievement (WJ-IV):

    1. KTEA-3 Math Concepts & Application
    2. KTEA-3 Math Fluency
    3. KTEA-3 Rapid Automatized Naming Letters
    4. KTEA-3 Spelling
    5. WJ-IV Science
    6. WJ-IV Social Studies
    7. WJ-IV Humanities

    This standard score will be obtained based on the z-score of the sum of subtest standard scores at pre-intervention.



Secondary Outcome Measures :
  1. Recidivism within 1 year post-intervention [ Time Frame: Within 1 year post-intervention ]
    Recidivism will be computed as a dichotomous variable (yes/no) indicating whether an individual committed an offense within 1 year after participating in the intervention.

  2. Number of days to recidivism within 1 year post-intervention [ Time Frame: Within 1 year post-intervention ]
    For individuals who recidivated within 1 year after participating in the intervention, the number of days until the first offense post-intervention will be computed.

  3. Detention within 1 year post-intervention [ Time Frame: Within 1 year post-intervention ]
    This secondary outcome will be computed as a dichotomous variable (yes/no) indicating whether an individual has been detained within 1 year after participating in the intervention.

  4. Number of days to detention within 1 year post-intervention [ Time Frame: Within 1 year post-intervention ]
    For individuals who were detained within 1 year after participating in the intervention, the number of days until the first detention post-intervention will be computed

  5. Adjudication within 1 year post-intervention [ Time Frame: Within 1 year post-intervention ]
    This secondary outcome will be computed as a dichotomous variable (yes/no) indicating whether an individual has been adjudicated within 1 year after participating in the intervention.

  6. Number of days to adjudication within 1 year post-intervention [ Time Frame: Within 1 year post-intervention ]
    For individuals who were adjudicated within 1 year after participating in the intervention, the number of days until the first adjudication post-intervention will be computed.


Other Outcome Measures:
  1. Changes in decoding skills as assessed by a SmartPhone App [ Time Frame: Participants will use the SmartPhone App over a 14-week game-play period. Data will be collected during game play. ]
    A SmartPhone App will be used to assess changes in decoding skills over a 14-week game-play period. Specifically, changes in decoding skills will be measured by tracking the level participants reach in the SmartPhone game. Level is determined by word frequency (a proxy for difficulty).

  2. Changes in word reading automaticity as assessed by a SmartPhone App [ Time Frame: Participants will use the SmartPhone App over a 14-week game-play period. Data will be collected during game play. ]
    A SmartPhone App will be used to assess changes in word reading automaticity over a 14-week game-play period. Specifically, word reading automaticity will be measured by tracking the speed at which participants are able to make decisions regarding spellings and sounds of words presented during the SmartPhone game

  3. Changes in breadth of vocabulary as assessed by a SmartPhone App [ Time Frame: Participants will use the SmartPhone App over a 14-week game-play period. Data will be collected during game play. ]
    A SmartPhone App will be used to assess changes in breadth of vocabulary over a 14-week game-play period. Specifically, vocabulary will be measured by tracking the percent correct participants reach on vocabulary tasks in the SmartPhone game.



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Ages Eligible for Study:   14 Years to 16 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between ages 14 and 16
  • Conversational English ability (sufficient to benefit from the intervention program) based on the CASL-2 core score
  • Reading below the 3rd grade level on the KTEA-3 pseudoword decoding subtest and the TOWRE-2 phonemic decoding efficiency subtest
  • IQ at or above 70 on the KABC-II

Exclusion Criteria:

  • Hearing or vision problem that would preclude the use of visual and auditory materials
  • Developmental delay, autism spectrum disorder, or intellectual disability
  • Known genetic syndrome
  • Neurological disorder (e.g., epilepsy)
  • Current psychosis or suicidal ideation
  • Recent (within 6 months) traumatic brain injury

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): NCT03261076


Contacts
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Contact: Lesley A Hart, PhD 713-743-8600 lahart@central.uh.edu
Contact: Sergey Kornilov, PhD sergey.kornilov@bcm.edu

Locations
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United States, Texas
Burnett-Bayland Rehabilitation Center (BBRC) Recruiting
Houston, Texas, United States, 77081
Contact: Jennifer Hunley    713-222-4421    jennifer.hunley@hcjpd.hctx.net   
Contact: Raymond Livingston       raymond.livingston@hcjpd.hctx.net   
Sponsors and Collaborators
Baylor College of Medicine
University of Houston
Harris County Juvenile Probation Department (HCJPD)
Connecticut Court Support Services Division (CSSD)
MindTrust Labs, LLC
Investigators
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Principal Investigator: Elena L Grigorenko, PhD BCM

Additional Information:
Publications:
Archwamety, T. & Katsiyannis, A. Academic remediation, parole violations, and recidivism rates among delinquent youths. Remedial and Special Education 21, 161-170 (2000).
Walker, H. M. & Sprague, J. R. The path to school failure, delinquency, and violence: Causal factors and some potential solutions. Intervention in School and Clinic 35, 67-73 (1999).
Wexler, J., Pyle, N., Flower, A., Williams, J. L. & Cole, H. A synthesis of academic interventions for incarcerated adolescents. Review of Educational Research 84, 3-46 (2014).
U.S. Department of Education, O. o. E. T. Enhancing teaching and learning through educational data mining and learning analytics: An issue brief. (U.S. Department of Education, Washington, DC, 2012)
Baker, R. S. J. D. & Yacef, K. The state of educational data mining in 2009: A review and future visions. Journal of Educational Data Mining 1, 3-16 (2009).

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Responsible Party: Elena, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03261076     History of Changes
Other Study ID Numbers: H-40232
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
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 Elena, Baylor College of Medicine:
Specific Learning Disorder
Learning Disorders
Neurodevelopmental Disorders
Mental Disorders
Developmental Reading Disability
Reading Disorder
Conduct Disorder

Additional relevant MeSH terms:
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Dyslexia
Disease
Conduct Disorder
Learning Disorders
Specific Learning Disorder
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms