Table 3.
Baseline, Week 11, and change in primary and secondary outcome measures
| Clinical Outcome | DCS (n=34) | Placebo (n=33) | ||||||
|---|---|---|---|---|---|---|---|---|
| Mean (SD) | Mean (SD) | |||||||
| Baseline | 11-week | Change | Baseline | 11-week | Change | Difference in Change Scores (95% CI) | P-value | |
| Primary outcome | ||||||||
| Social Responsiveness Scale (SRS) Parent Raw Scores | ||||||||
| Social awareness | 12.82 (3.43) | 12.15 (2.73) | -0.76 (2.60) | 13.82 (3.59) | 12.94 (2.67) | -1.00 (3.12) | 0.24 (-1.19 to 1.67) | .74 |
| Social cognition | 19.18 (5.37) | 17.21 (6.01) | -1.94 (4.41) | 20.88 (4.34) | 18.06 (4.24) | -2.68 (3.74) | 0.74 (-1.31 to 2.79) | .47 |
| Social communication | 34.94 (8.65) | 30.00 (8.55) | -4.91 (6.49) | 37.97 (7.84) | 32.03 (7.71) | -6.19 (8.40) | 1.28 (-2.45 to 5.02) | .49 |
| Social motivation | 16.06 (5.84) | 13.18 (5.01) | -2.76 (3.95) | 16.33 (5.34) | 13.39 (5.17) | -3.06 (4.40) | 0.31 (-1.78 to 2.40) | .54 |
| Autistic mannerisms | 19.44 (6.10) | 16.42 (6.03) | -2.82 (5.24) | 21.42 (6.27) | 17.65 (5.36) | -4.10 (6.38) | 1.28 (-1.63 to 4.19) | .38 |
| SRS Parent Total Score | 102.35 (25.09) | 88.67 (22.74) | -13.39 (16.81) | 110.33 (20.43) | 94.00 (19.31) | -17.00 (21.33) | 3.61 (-5.96 to 13.17) | .45 |
| Secondary outcomes | ||||||||
| VABS-II raw scores | ||||||||
| Communication | 152.56 (17.05) | 156.47 (17.85) | 3.63 (8.26) | 147.06 (22.18) | 154.58 (21.93) | 6.77 (11.15) | -3.15 (-8.08 to 1.79) | .21 |
| Daily living skills | 231.62 (26.08) | 239.56 (26.99) | 7.06 (14.72) | 229.67 (35.43) | 239.29 (35.76) | 8.45 (16.82) | -1.39 (-9.35 to 6.57) | .73 |
| Socialization | 113.26 (24.98) | 126.53 (27.54) | 12.34 (20.00) | 103.97 (22.14) | 117.35 (27.94) | 12.10 (22.28) | 0.25 (-10.41 to 10.91) | .96 |
| Motor skills | 141.21 (7.21) | 143.59 (5.42) | 2.22 (5.70) | 141.27 (9.50) | 142.19 (9.59) | 0.19 (3.81) | 2.03 (-0.41 to 4.46) | .10 |
| Maladaptive behavior | 16.65 (6.87) | 15.88 (7.12) | -0.59 (5.92) | 18.55 (7.42) | 16.42 (5.59) | -2.03 (5.91) | 1.44 (-1.54 to 4.42) | .34 |
| Total | 655.29 (59.88) | 682.03 (64.28) | 24.66 (37.56) | 640.52 (78.65) | 669.84 (83.74) | 25.48 (41.11) | -0.83 (-20.66 to 19.00) | .93 |
| ABC parent score | ||||||||
| Irritability | 11.06 (8.05) | 9.12 (6.63) | -1.55 (6.11) | 12.67 (8.96) | 11.06 (7.42) | -1.23 (6.09) | -0.32 (-3.37 to 2.73) | .83 |
| Social Withdrawal | 10.29 (8.30) | 8.06 (7.61) | -2.39 (4.71) | 10.39 (8.33) | 8.81 (6.41) | -1.71 (7.04) | -0.68 (-3.71 to 2.34) | .65 |
| Stereotypy | 4.94 (4.21) | 4.64 (4.89) | -0.33 (2.79) | 4.64 (4.32) | 4.32 (3.75) | -0.45 (4.60) | 0.12 (-1.81 to 2.04) | .90 |
| Hyperactivity | 18.82 (11.26) | 17.30 (12.23) | -1.55 (7.37) | 19.00 (9.18) | 16.87 (9.49) | -2.03 (9.39) | 0.49 (-3.72 to 4.69) | .82 |
| Inappropriate speech | 3.91 (3.04) | 3.24 (2.26) | -0.73 (2.59) | 4.36 (2.85) | 4.68 (3.29) | 0.35 (2.67) | -1.08 (-2.40 to 0.23) | .10 |
| TSSA parent | 53.74 (8.61) | 57.84 (9.11) | 3.88 (3.49) | 48.79 (8.91) | 54.34 (10.37) | 5.83 (9.70) | -1.95 (-6.87 to 2.97) | .43 |