Table 2.
Comparison of the two randomized treatment groups on symptom scores at key time points and comparison of change in scores over time. Lower score is better on all scales.
| Measure | Treatment Group | Baseline Mean (sd) | Mean Diff (sd) at Baseline p-value |
End of RUPP Main Study (24Weeks) Mean (sd) |
Mean Diff (sd) at 24 Weeks p-value |
End of Follow-Up Mean (sd) |
Mean Diff (sd) At Follow-up p-value |
Change BL to 24wk Mean Diff (sd) p-value ES d |
Change BL to FU Mean Diff (sd) p-value ES d |
|---|---|---|---|---|---|---|---|---|---|
| HSQ mean | MED | 4.41 (1.51) | 0.052 (1.58) p = 0.88 |
1.85 (1.32) | 0.57 (1.28) p = 0.0431 |
2.12 (1.87) | 0.28 (1.64) p = 0.43 |
0.52 (1.63) p = 0.14 d = 0.32 |
0.23 (1.86) p = 0.57 d = 0.12 |
| COMB | 4.35 (1.63) | 1.28 (1.26) | 1.84 (1.46) | ||||||
| HSQ Yeses | MED | 19.67 (3.05) | 0.59 (3.96) p = 0.47 |
12.00 (6.80) | 1.59 (6.89) p= 0.29 |
13.67 (7.04) | 0.98 (6.40) p = 0.48 |
1.00 (6.79) p = 0.50 d = 0.15 |
0.39 (6.85) P = 0.79 d = 0.06 |
| COMB | 19.08 (4.48) | 10.41 (6.96) | 12.69(5.91) | ||||||
| ABC I Irritability Subscale | MED | 29.86 (6.40) | 0.82 (6.32) p= 0.55 |
15.64 (8.47) | 4.58 (7.68) p = 0.0075 |
15.25 (3.36) | 1.15 (9.50) p = 0.58 |
3.76 (8.19) p = 0.038 d = 0.46 |
0.33 (9.93) p = 0.88 d = 0.03 |
| COMB | 29.04 (6.26) | 11.06 (7.07) | 14.10 (3.60) | ||||||
| ABC II Lethargy Subscale | MED | 18.42 (8.20) | 4.00 (8.88) p = 0.0413 |
6.81 (6.97) | 2.57 (5.95) p= 0.0645 |
7.39 (6.83) | 2.74 (5.93) p= 0.0365 |
−1.43 (7.17) p = 0.36 d = 0.20 |
−1.26 (8.00) p = 0.47 d = 0.16 |
| COMB | 14.41 (9.33) | 4.24 (5.11) | 4.65 (5.21) | ||||||
| ABC III Stereotypy Subscale | .MED | 10.50 (5.44) | 2.87 (5.25) p = 0.0139 |
6.58 (5.68) | 3.72 (4.55) p = 0.0010 |
5.61(5.31) | 1.55 (4.42) p = 0.14 |
0.85(3.96) −p = 0.33 d = 0.21 |
−1.32 (4.95) p = 0.22 d = 0.27 |
| COMB | 7.63 (5.14) | 2.86 (3.56) | 4.06 (3.67) | ||||||
| ABC IV Hyperactivity Subscale | MED | 36.08 (6.36) | 1.73 (8.10) p = 0.30 |
21.83 (10.96) | 6.46 (10.39) p = 0.0054 |
18.94 (11.42) | 1.57(11.63) p = 0.54 |
4.73(9.25) p = 0.02 d = 0.51 |
−0.16 (10.67) p = 0.95 d = 0.01 |
| COMB | 34.35 (9.13) | 15.37 (9.98) | 17.37(11.78) | ||||||
| ABC V Inappropriate Speech Subscal | MED | 5.83(3.90) | 0.03(3.69) p = 0.97 |
2.92 (3.44) | 0.49 (3.00) p = 0.46 |
3.22(3.36) | −0.05 (3.03) p = 0.94 |
0.46 (3.14) p = 0.51 d = 0.15 |
−0.08 (3.24) p = 0.91 d = 0.02 |
| COMB | 5.80(3.53) | 2.43 (2.64) | 3.27 (2.77) |
Note: ABC = Aberrant Behavior Checklist; MED = medication alone; COMB = medication + parent training in behavior management; Tx = treatment; sd = standard deviation; Diff = Difference; FU = follow up; BL = Baseline; wk = week; ES = effect size d.