Table 1.
Participant demographics and clinical characteristics at baseline
| High‐dose group | Low‐dose group | Placebo‐to‐high‐dose control group | |||
|---|---|---|---|---|---|
| Demographics and clinical characteristics | (n = 50) | (n = 51) | (n = 50) | F or x 2 | P‐value |
| Age, years, mean (SD) | 4.8 (1.7) | 5.3 (2.5) | 5.6 (2.2) | 1.92 | 0.150 |
| Age group, 2–6 years, n (%) | 43 (86.0) | 39 (37.3) | 34 (26.0) | 4.55 | 0.104 |
| Sex, male, n (%) | 45 (90.0) | 39 (76.5) | 41 (82.0) | 3.27 | 0.195 |
| Height, cm, mean (SD) | 111.8 (12.9) | 114.1 (15.8) | 116.0 (13.2) | 1.11 | 0.334 |
| Weight, kg, mean (SD) | 21.9 (7.5) | 23.2 (10.0) | 24.8 (9.1) | 1.30 | 0.279 |
| Comorbid psychiatric and genetic disorders | |||||
| Intellectual disability, n (%) | 40 (80.0) | 44 (86.3) | 38 (76.0) | 1.75 | 0.419 |
| ADHD, n (%) | 7 (14.0) | 8 (15.7) | 9 (18.0) | 0.30 | 0.890 |
| Tourette disorder, n (%) | 1 (2.0) | 0.662* | |||
| Fragile X syndrome, n (%) | 1 (2.0) | 0.662* | |||
| History of psychotropic medication use | 11 (22.0) | 8 (15.7) | 9 (18.0) | 0.702* | |
| History of psychosocial intervention | 50 (100.0) | 49 (96.1) | 49 (98.0) | 0.773* | |
| Baseline K‐VABS‐II ABC score | 49.9 (10.0) | 50.8 (11.6) | 48.5 (10.6) | 0.59 | 0.554 |
| Baseline K‐VABS‐II Communication score | 52.7 (12.5) | 54.2 (13.8) | 52.4 (11.8) | 0.29 | 0.750 |
| Baseline K‐VABS‐II Daily Living Skills score | 59.3 (13.8) | 59.2 (13.4) | 57.0 (14.2) | 0.42 | 0.659 |
| Baseline K‐VABS‐II Socialization score | 50.1 (9.5) | 50.5 (10.8) | 47.8 (10.5) | 0.97 | 0.382 |
| Baseline K‐VABS‐II Motor Skills score | 67.5 (9.8) | 69.2 (12.6) | 66.9 (10.5) | 0.45 | 0.638 |
| Baseline K‐VABS‐II Maladaptive Behavior score | 20.4 (2.0) | 19.9 (2.6) | 21.0 (2.4) | 2.56 | 0.081 |
| Baseline CGI‐S score | 5.1 (0.9) | 5.0 (0.9) | 5.0 (1.0) | 0.31 | 0.735 |
| Baseline SRS‐2 total T‐score | 76.2 (9.2) | 75.2 (10.2) | 80.0 (10.7) | 3.18 | 0.045 |
| Baseline Aberrant Behavior Checklist–Irritability | 11.7 (6.9) | 11.1 (8.0) | 13.7 (9.6) | 1.43 | 0.242 |
| Baseline K‐PSI‐4‐SF Parental Distress | 35.7 (8.5) | 35.3 (7.3) | 36.8 (8.3) | 0.44 | 0.643 |
*
Using Fisher exact test.
ABC, Adaptive Behavior Composite; ADHD, attention‐deficit/hyperactivity disorder; CGI‐S, Clinical Global Impression‐Severity; K‐PSI‐4‐SF, Korean‐Parenting Stress Index‐4th Edition‐Short Form; K‐VABS‐II, Korean Vineland Adaptive Behavior Scales, 2nd Edition; SRS‐2, Social Responsiveness Scale, 2nd Edition.