Recruiting

Observational Study

Sponsor:

Baylor College of Medicine

Code:

NCT03261076

Conditions

Specific Learning Disorder (MeSH Unique ID: D000067559)

Dyslexia (MeSH Unique ID: D004410)

Conduct Disorder (MeSH Unique ID: D019955)

Eligibility Criteria

Sex: Male

Age: 14 - 16

Healthy Volunteers: Not accepted

Interventions

Strategies Enhancing Reading in Older Underperf. Students

Study Details

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.

Conditions

Specific Learning Disorder (MeSH Unique ID: D000067559)

Dyslexia (MeSH Unique ID: D004410)

Conduct Disorder (MeSH Unique ID: D019955)

Study ID

NCT03261076

Start date

May 14, 2018

Status verified date

Feb, 2022

Completion date

Jun 30, 2022

Anticipated

Primary completion date

Jun 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 14 - 16

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

192 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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 measure

  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Sergey Kornilov, PhD

sergey.kornilov@bcm.edu

Locations

Burnett-Bayland Rehabilitation Center (BBRC)

Recruiting

Houston, Texas, United States, 77081

Contacts

More Information

Sponsor

Baylor College of Medicine

Last update posted

Mar 2, 2022

Last verified

Feb, 2022

Keywords

  • Specific Learning Disorder
  • Learning Disorders
  • Neurodevelopmental Disorders
  • Mental Disorders
  • Developmental Reading Disability
  • Reading Disorder
  • Conduct Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2022-03-02.