Clinical trial: Improving STEM Outcomes for Young Children With Language Learning Disabilities (NCT03438760)

Eligibility criteria:
Inclusion Criteria:

          -  Age between 4 and 7 years

          -  Not yet begun first grade

          -  Speaks English as their primary language

          -  Has SLI confirmed by 1) a standard score of 94 or lower on the Structured Photographic
             Expressive Language Test, 3rd edition (SPELT-III, Dawson, Stout, & Eyer, 2003) OR
             below a scaled score of 7 on the Diagnostic Evaluation of Language Variance™-Norm
             Referenced (DELV-NR, Seymour, Roeper, & de Villiers, 2005) syntax subtest; AND 2)
             performing below age-relevant cutoffs on the Dollaghan and Campbell (1998) Nonword
             Repetition Task OR enrollment on a clinical caseload.

          -  Nonverbal matrices t score of 35 or higher on the Developmental Abilities Scale

          -  Passes a pure-tone audiometric screening administered according to the standards of
             the American Speech-Language-Hearing Association (ASHA, 1997)

          -  Can produce simple sentences that contain a subject and a verb.

          -  Performs with less than 40% accuracy on expressive probes of complement clauses prior
             to study onset

          -  Performs with less than 40% accuracy on vocabulary definition probes prior to study
             onset

        Exclusion Criteria:

          -  Other diagnosed neurodevelopmental disorders (e.g., autism, Down syndrome) via parent
             report or significant sensory or motor impairments (e.g., severe vision impairment
             uncorrectable by glasses)

          -  Exposure to a language other than English at home or school more than 20% of the time.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 7 Years

Patient description (medical language): A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination.  The boy is going to a school for students with learning disabilities.  The patient was adopted, and his immunizations are up to date.  Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value      Normal Range     Patient Value
Glucose                    90-120 mg/dl     95 mg/dl
BUN (Blood Urea Nitrogen)  7-24 mg/dl       10 mg/dl
Creatinine                 0.7-1.4 mg/dl    0.8 mg/dl
Calcium                    8.5-10.5 mg/dl   9 mg/dl
Sodium                     134-143 mEq/L    135 mEq/L
Potassium                  3.5-4.5 mEq/L    3.7 mEq/L
Chloride                   95-108 mEq/L     98 mEq/L
CO2                        20-30 mEq/L      25 mEq/L
Blood pH                   7.38-7.42        7. 39

Patient description (patient's own words): My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range.

Does the patient match the trial criteria? Contradiction