Clinical trial: Families of Youth With Developmental Disabilities: A Theory-Based Intervention (NCT03495440)

Eligibility criteria:
Inclusion Criteria:

          -  Participants in all conditions will include mothers, fathers, TD siblings between 11
             and 17 years old, and individuals with IDD of any age.

          -  Participants must be able to understand and respond to survey questions in English

          -  Parents must be cohabitating, with both participating children living in their home.

          -  Individual with IDD falls into one or more of the following categories: 1) meets
             criteria for an intellectual disability, which would mean a measured IQ of 70-75 or
             lower and a measured Adaptive Functioning score of 70-75 or lower, 2) meets criteria
             for an Autism Spectrum Disorder based on an evaluation using the ADOS-2, SCQ, and
             expert clinical judgment based on DSM-5 ASD criteria, or 3) has a medically verified
             genetic condition (e.g., Down syndrome, Fragile X syndrome, Williams syndrome,
             Angelman syndrome, others) that is generally considered to be a developmental
             disability, and shows cognitive or adaptive functioning deficits (70-75 or below)
             although not necessarily deficits in both categories as would be needed for an
             Intellectual Disability diagnosis.

        Exclusion Criteria:

          -  Siblings identified as typically developing will be excluded 1) with a score of 10 or
             higher on the SCQ-L, if a subsequent ADOS suggests that they have an ASD diagnosis, or
             2) with a WASI-II score of 75 or lower.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers



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? 1