Table 4 Summary of mixed model analysis of primary and secondary outcomes (N = 540)
Measurements | Visit | 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 | Baseline | 270 | 56.13 (22.56) | 270 | 53.65 (23.08) | ||
6 months post-intervention | 221 | 47.65 (26.94) | 239 | 48.72 (26.37) | − 2.63 (− 6.50, 1.24) | 0.1820 | |
DD-CDAS—understanding and communication | Baseline | 270 | 59.15 (25.07) | 270 | 58.81 (24.16) | ||
6 months post-intervention | 221 | 49.21 (26.97) | 239 | 51.08 (27.87) | − 1.28 (− 6.53, 3.96) | 0.6304 | |
DD-CDAS—getting around | Baseline | 270 | 45.17 (42.32) | 270 | 43.56 (40.99) | ||
6 months post-intervention | 221 | 37.40 (43.10) | 239 | 39.64 (41.14) | − 2.66 (− 6.75, 1.44) | 0.2024 | |
DD-CDAS—self-care | Baseline | 270 | 65.97 (28.24) | 61.02 (29.28) | |||
6 months post-intervention | 221 | 54.58 (33.46) | 239 | 53.09 (32.77) | − 2.66 (− 6.74, 1.43) | 0.2020 | |
DD-CDAS—getting along with people | Baseline | 270 | 51.52 (28.85) | 270 | 49.11 (28.12) | ||
6 months post-intervention | 221 | 42.85 (30.23) | 239 | 46.07 (30.49) | − 3.60 (− 9.63, 2.42) | 0.2404 | |
DD-CDAS—participation in society | Baseline | 270 | 42.74 (21.84) | 270 | 39.27 (23.30) | ||
6 months post-intervention | 221 | 37.99 (24.18) | 239 | 38.06 (22.91) | − 1.70 (− 7.82, 4.42) | 0.5862 | |
DD-CDAS—life activities | Baseline | 270 | 72.21 (24.76) | 270 | 70.11 (23.99) | ||
6 months post-intervention | 221 | 63.90 (31.47) | 239 | 64.40 (30.16) | − 1.83 (− 6.33, 2.67) | 0.4245 | |
PedsQL total score | Baseline | 270 | 58.56 (17.37) | 270 | 60.66 (18.69) | ||
6 months post-intervention | 221 | 65.56 (23.25) | 237 | 62.17 (22.63) | 5.28 (0.44,10.11) | 0.0325 | |
PedsQL—parental health related quality of life | Baseline | 270 | 57.09 (20.37) | 270 | 57.90 (22.14) | ||
6 months post-intervention | 221 | 63.92 (24.70) | 237 | 60.58 (24.75) | 4.43 (− 0.53, 9.39) | 0.0797 | |
PedsQL—family functioning | Baseline | 270 | 71.63 (22.64) | 270 | 74.16 (20.26) | ||
6 months post-intervention | 221 | 72.68 (24.32) | 237 | 70.27 (25.04) | 3.88 (− 1.72, 9.48) | 0.1738 | |
PedsQL—physical functioning | Baseline | 270 | 48.61 (23.46) | 270 | 51.74 (25.14) | ||
6 months post-intervention | 221 | 61.39 (28.93) | 237 | 57.17 (29.46) | 5.73 (− 0.53, 12.00) | 0.0728 | |
PedsQL—emotional functioning | Baseline | 270 | 51.91 (26.79) | 270 | 51.97 (27.17) | ||
6 months post-intervention | 221 | 61.76 (26.12) | 237 | 56.08 (28.03) | 6.23 (0.52, 11.94) | 0.0325 | |
PedsQL—social functioning | Baseline | 270 | 65.93 (26.55) | 270 | 65.46 (26.86) | ||
6 months post-intervention | 221 | 67.79 (30.62) | 237 | 64.87 (30.18) | 3.10 (− 3.43, 9.63) | 0.3515 | |
PedsQL—cognitive functioning | Baseline | 270 | 65.37 (27.28) | 270 | 65.13 (27.64) | ||
6 months post-intervention | 221 | 66.04 (29.25) | 237 | 65.74 (29.88) | 1.24 (− 4.15, 6.63) | 0.6509 | |
PedsQ—communication total | Baseline | 270 | 66.44 (24.12) | 270 | 71.45 (23.48) | ||
6 months post-intervention | 221 | 70.72 (28.37) | 237 | 66.75 (28.20) | 5.85 (− 0.25, 11.95) | 0.0602 | |
PedsQL—worry | Baseline | 270 | 38.71 (22.16) | 270 | 43.60 (22.33) | ||
6 months post-intervention | 221 | 57.58 (28.66) | 237 | 52.85 (30.09) | 6.66 (0.00,13.33) | 0.0499 | |
PedsQL—daily activities | Baseline | 270 | 54.81 (31.15) | 270 | 55.80 (30.95) | ||
6 months post-intervention | 221 | 57.96 (33.65) | 237 | 56.01 (35.92) | 2.95 (− 5.61, 11.52) | 0.4984 | |
PedsQL—family relationship | Baseline | 270 | 81.72 (23.57) | 270 | 85.17 (20.92) | ||
6 months post-intervention | 221 | 81.52 (24.35) | 237 | 78.84 (26.59) | 4.04 (− 1.65, 9.73) | 0.1632 | |
SDQ total socio emotional difficulties | Baseline | 270 | 16.50 (5.56) | 270 | 16.50 (6.04) | ||
6 months post-intervention | 221 | 16.24 (6.13) | 238 | 16.98 (6.38) | − 0.79 (− 2.24, 0.66) | 0.2840 | |
SDQ—emotional symptoms | Baseline | 270 | 3.73 (2.44) | 270 | 3.94 (2.48) | ||
6 months post-intervention | 221 | 3.64 (2.41) | 238 | 4.04 (2.53) | − 0.36 (− 0.97, 0.25) | 0.2460 | |
SDQ—conduct problems | Baseline | 270 | 3.28 (1.99) | 270 | 3.23 (2.11) | ||
6 months post-intervention | 221 | 3.49 (1.86) | 238 | 3.61 (1.86) | − 0.13 (− 0.57, 0.30) | 0.5434 | |
SDQ—hyperactivity symptoms | Baseline | 270 | 5.22 (2.29) | 270 | 5.29 (2.25) | ||
6 months post-intervention | 4.77 (2.42) | 4.90 (2.36) | − 0.12 (− 0.54, 0.31) | 0.5965 | |||
SDQ—peer problems | Baseline | 4.27 (2.02) | 4.04 (2.21) | ||||
6 months post-intervention | 221 | 4.33 (2.03) | 238 | 4.43 (2.29) | − 0.19 (− 0.69, 0.31) | 0.4550 | |
SDQ—pro social | Baseline | 270 | 4.49 (2.94) | 270 | 4.96 (3.26) | ||
6 months post-intervention | 221 | 4.86 (3.09) | 238 | 5.20 (3.06) | − 0.12 (− 0.60, 0.37) | 0.6395 | |
FES total score | Baseline | 270 | 40.77 (11.07) | 270 | 39.74 (10.16) | ||
6 months post-intervention | 221 | 41.41 (9.78) | 237 | 40.89 (9.52) | 0.47 (− 1.70, 2.64) | 0.6701 | |
FES—service system | Baseline | 270 | 34.60 (12.37) | 270 | 34.24 (10.97) | ||
6 months post-intervention | 221 | 39.24 (11.59) | 237 | 38.72 (11.79) | 0.55 (− 2.64, 3.75) | 0.7344 | |
FES—community involvement | Baseline | 270 | 19.30 (7.48) | 270 | 18.87 (7.08) | ||
6 months post-intervention | 221 | 20.28 (8.21) | 237 | 19.48 (7.09) | 1.117 (− 2.20, 0.607) | 0.26 | |
FES—attitude | Baseline | 270 | 31.70 (9.31) | 270 | 30.86 (8.60) | ||
6 months post-intervention | 221 | 32.84 (8.73) | 237 | 32.23 (8.21) | 0.53 (− 0.99, 2.05) | 0.4936 | |
FES—knowledge | Baseline | 270 | 32.61 (10.24) | 270 | 32.32 (9.15) | ||
6 months post-intervention | 221 | 36.14 (10.73) | 237 | 35.45 (9.91) | 0.81 (− 1.63, 3.24) | 0.5160 | |
FES—behaviours | Baseline | 270 | 30.36 (9.76) | 270 | 29.66 (8.75) | ||
6 months post-intervention | 221 | 31.95 (8.78) | 237 | 31.42 (8.45) | 0.46 (− 1.72, 2.65) | 0.6768 | |
ISE | Baseline | 270 | 2.46 (2.03) | 270 | 2.51 (2.27) | ||
6 months post-intervention | 221 | 2.23 (2.05) | 237 | 2.42 (2.23) | − 0.21 (− 0.70, 0.28) | 0.3967 | |