Table 5 Summary of mixed model analysis of primary and secondary outcomes (changes from baseline): covariate adjusted analysis
Primary and secondary outcomes | Descriptive statistics | Mixed model analysis | ||||
|---|---|---|---|---|---|---|
Intervention arm | ETAU arm | Difference in mean (95% CI) | p-value | |||
n | Mean (SD) | n | Mean (SD) | |||
DD-CDAS—total disability score | 221 | − 7.34 (17.07) | 239 | − 4.50 (15.95) | − 2.74 (− 6.63,1.14) | 0.1662 |
DD-CDAS—understanding and communication | 221 | − 9.16 (23.72) | 239 | − 7.79 (21.48) | − 2.68 (− 7.55, 2.19) | 0.2797 |
DD-CDAS—getting around | 221 | − 5.63 (23.63) | 239 | − 2.91 (22.43) | − 3.01 (− 7.05, 1.03) | 0.1442 |
DD-CDAS—self-care | 221 | − 10.29 (21.96) | 239 | − 7.03 (21.50) | − 1.50 (− 5.68, 2.69) | 0.4826 |
DD-CDAS—getting along with people | 221 | − 7.04 (29.09) | 239 | − 2.91 (28.72) | − 4.33 (− 9.90, 1.23) | 0.1268 |
DD-CDAS—participation in society | 221 | − 3.83 (25.35) | 239 | − 0.45 (24.44) | − 1.47 (− 7.10, 4.16) | 0.6076 |
DD-CDAS—life activities | 221 | − 8.08 (24.30) | 239 | − 5.92 (23.01) | − 2.06 (− 6.83,2.71) | 0.3965 |
PedsQL total score | 221 | 7.17 (21.85) | 237 | 0.77 (20.96) | 5.35 (0.62, 10.09) | 0.0268 |
PedsQL—parent health related Quality of life | 221 | 7.08 (24.72) | 237 | 1.90 (22.97) | 4.70 (− 0.19, 9.58) | 0.0597 |
PedsQL—family functioning | 221 | 1.54 (27.29) | 237 | − 4.23 (25.93) | 3.90 (− 1.63, 9.43) | 0.1663 |
PedsQL—physical functioning | 221 | 12.50 (31.14) | 237 | 5.13 (28.64) | 6.21 (− 0.10, 12.52) | 0.0538 |
PedsQL—Emotional functioning | 221 | 10.29 (29.08) | 237 | 3.50 (30.44) | 6.43 (0.82, 12.05) | 0.0248 |
PedsQL—social functioning | 221 | 1.67 (33.69) | 237 | − 1.50 (33.50) | 3.63 (− 2.71, 9.98) | 0.2605 |
PedsQL—cognitive functioning | 221 | 1.72 (33.63) | 237 | − 0.84 (30.43) | 1.41 (− 3.84, 6.66) | 0.5967 |
PedsQL—communication | 221 | 4.07 (30.07) | 237 | − 5.50 (32.18) | 5.92 (− 0.09, 11.93) | 0.0536 |
PedsQL—worry | 221 | 18.43 (31.15) | 237 | 7.99 (31.91) | 6.76 (0.31, 13.21) | 0.0401 |
PedsQL—daily activities | 221 | 3.81 (36.08) | 237 | − 0.74 (39.50) | 3.29 (− 4.89, 11.47) | 0.4298 |
PedsQL—family relationship | 221 | 0.18 (29.73) | 237 | − 6.31 (28.22) | 3.99 (− 1.77, 9.75) | 0.1744 |
SDQ total socio emotional difficulties | 221 | − 0.50 (6.54) | 238 | 0.44 (6.69) | − 0.84 (− 2.25, 0.57) | 0.2431 |
SDQ—emotional symptoms | 221 | − 0.17 (2.99) | 238 | 0.11 (2.97) | − 0.40 (− 1.00, 0.19) | 0.1863 |
SDQ—conduct problems | 221 | 0.15 (2.12) | 238 | 0.36 (2.21) | − 0.13 (− 0.56, 0.30) | 0.5395 |
SDQ—hyperactivity symptoms | 221 | − 0.49 (2.74) | 238 | − 0.40 (2.61) | − 0.14 (− 0.55, 0.26) | 0.4853 |
SDQ—peer problems | 221 | 0.00 (2.34) | 238 | 0.37 (2.65) | − 0.17 (− 0.68, 0.33) | 0.4934 |
SDQ—pro social | 221 | 0.31 (2.82) | 238 | 0.27 (2.80) | − 0.11 (− 0.59, 0.36) | 0.6401 |
FES total scores | 221 | 1.41 (13.03) | 237 | 1.18 (11.69) | 0.41 (− 1.74, 2.57) | 0.7085 |
FES-service system | 221 | 5.50 (14.56) | 237 | 4.79 (13.48) | 0.47 (− 2.71, 3.65) | 0.7711 |
FES—community involvement | 221 | 193.00 (86.34) | 237 | 180.97 (85.25) | 13.09 (− 4.07, 30.25) | 0.1346 |
FES—attitude | 221 | 1.87 (10.22) | 237 | 1.50 (9.81) | 0.48 (− 1.04, 2.01) | 0.5351 |
FES—knowledge | 221 | 4.22 (11.47) | 237 | 3.19 (11.21) | 0.76 (− 1.69, 3.21) | 0.5426 |
FES—behaviour | 221 | 2.23 (11.14) | 237 | 1.95 (10.32) | 0.39 (− 1.78, 2.55) | 0.7258 |
ISE | 221 | − 0.33 (2.41) | 237 | − 0.04 (2.56) | − 0.20 (− 0.69, 0.29) | 0.4169 |