Clinical trial: Pivotal Response Treatment for Individuals With Intellectual Disabilities (NCT01988623)

Eligibility criteria:
Inclusion Criteria for Individuals with Intellectual Disabilities:

          -  Participants will have an age range between 2 and 17.11 years of age inclusive

          -  Male or female

          -  Diagnosis of an intellectual disability based on the fourth edition of the Diagnostic
             and Statistical Manual of Mental Disorders (DSM-IV-TR), the 10th revision of the
             International Statistical Classification of Diseases and Related Health Problems
             (ICD-10), and an expert clinical evaluation

          -  have historical evidence of significant abnormal developmental milestones as
             determined by neurological history

          -  care provider that will reliably bring subject to study visits, and is trustworthy to
             provide accurate accounts of services provided to the subject

        Inclusion Criteria for Individuals with Speech Delay/Language Disorder:

          -  Participants will have an age range between 2 and 17.11 years of age inclusive

          -  Male or female

          -  Diagnosis of a speech delay based on the fourth edition of the Diagnostic and
             Statistical Manual of Mental Disorders (DSM-IV-TR), the 10th revision of the
             International Statistical Classification of Diseases and Related Health Problems
             (ICD-10), and an expert clinical evaluation

          -  Preschool Language scale (PLS) score of at least 1 standard deviations below age level
             (for children in the age range of 2-6.11)

          -  care provider that will reliably bring subject to study visits, and is trustworthy to
             provide accurate accounts of services provided to the subject

        Exclusion Criteria:

          -  medically unstable (such as having unstable seizures)

          -  primary diagnosis of Autism Spectrum Disorder (ASD) is exclusionary as determined by
             the investigators
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 17 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? Entailment