Table 2.
Screening Visit Inclusion/Exclusion Criteria
| Core Criteria | Measures | Inclusion Criteria | Rationale |
|---|---|---|---|
| Standardized age | Age | • 8 years of age | Age-based cohort that limits inclusion of individuals with precocious puberty |
| Clinical confirmation of prepubertal status | Pubertal Stage (PS) | • Breast/testicular volume = PS1 • Pubic hair = PS1 |
Baseline to compare longitudinal progression through the pubertal transition |
| Standardized body mass index (BMI) | BMI (kg/m2) | • BMI between the 15th and 85th percentiles | Limit confounding influence of adiposity on pubertal timing and trajectory |
| Standardized skeletal bone-age | Skeletal Maturity Index (bone-age) | • 90% Confidence Interval of sex and Chronologic age means1 | No evidence for precocious/delayed puberty; integrative measure of health and development during early life |
| Typical cognitive and behavioral development | Clinical Interview (K-SADS) | • No personal or family history of Axis I disorders • No significant neurologic or cognitive disorders • No current or past use of psychiatric medication |
No Symptoms of psychopathology |
| Clinical Interview (History) | • Normal pregnancy and delivery • Normal birthweight • Met all development milestones |
No evidence of early life issues related to development | |
| TIWRE2 | • IQ score ≥ 70 | Typical cognitive development |
1
Greulich and Pyle, 1959
2
Reynolds and Kamphaus, 2007