TABLE 2.
Outcomes at baseline, 6 and 12 months post-enrollment to the baby Ubuntu program, by arm.
| Outcome | Baseline measures | Outcomes at 6 months post-enrollment | Outcomes at 12 months post-enrollment | |||||||
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| Standard care (n = 63) mean (SD) | Baby Ubuntu (n = 63) mean (SD) | Standard care (n = 54) mean (SD) | Baby Ubuntu (n = 55) mean (SD) | Crude difference (95% CI)1 | Adjusted difference (95% CI)2 | Standard care (n = 52) mean (SD) | Baby Ubuntu (n = 49) mean (SD) | Crude difference (95% CI)1 | Adjusted difference (95% CI)2 | |
| PedsQL | ||||||||||
| Total score | 61.2 (19.1) | 64.8 (18.7) | 60.1 (18.1) | 58.2 (18.1) | −1.9 (−8.8, 5.0) | −5.4 (−11.4, 0.6) | 58.2 (21.8) | 61.5 (22.6) | 3.4 (−5.4, 12.1) | −0.7 (−8.9, 7.5) |
| Physical functioning | 65.2 (20.8) | 64.8 (21.5) | 64.8 (22.0) | 61.4 (25.0) | −3.3 (−12.3, 5.7) | −3.9 (−12.1, 4.3) | 64.0 (23.2) | 64.1 (27.5) | 0.1 (−9.9, 10.1) | −1.0 (−10.6, 8.6) |
| Emotional functioning | 53.8 (29.6) | 59.4 (27.9) | 53.8 (28.8) | 55.5 (28.1) | 1.7 (−9.2, 12.6) | −0.8 (−10.9, 9.3) | 51.4 (30.3) | 56.5 (31.4) | 5.1 (−7.1, 17.2) | 1.1 (−10.3, 12.5) |
| Social functioning | 59.9 (30.2) | 63/3 (28.6) | 56.0 (31.6) | 48.3 (30.3) | −7.8 (−19.6, 4.0) | −10.8 (−22.1, 0.5) | 52.2 (34.3) | 53.2 (32.7) | 1.0 (−12.2, 14.3) | −1.6 (−14.6, 11.5) |
| Cognitive functioning | 77.9 (23.3) | 79.0 (24.3) | 75.9 (23.9) | 71.9 (24.1) | −4.1 (−13.3, 5.1) | −5.7 (−14.0, 2.5) | 71.8 (25.1) | 78.8 (25.9) | 6.9 (−3.1, 17.0) | 4.8 (−5.2, 14.9) |
| Communication | 56.7 (27.4) | 55.8 (25.5) | 48.0 (19.6) | 51.2 (23.5) | 3.3 (−5.0, 11.5) | 2.3 (−5.7, 10.3) | 55.1 (22.1) | 59.9 (31.8) | 4.8 (−6.0, 15.6) | 3.0 (−7.6, 13.6) |
| Worry | 44.9 (26.5) | 51.9 (26.3) | 46.9 (26.0) | 44.4 (25.2) | −2.5 (−12.3, 7.3) | −7.0 (−16.0, 2.0) | 44.3 (27.9) | 51.9 (30.4) | 7.6 (−3.9, 19.1) | 2.1 (−8.9, 13.1) |
| Daily activities | 54.4 (35.1) | 62.8 (33.4) | 52.2 (31.6) | 51.4 (38.1) | −0.8 (−14.2,12.5) | −7.8 (−20.2, 4.6) | 50.5 (35.8) | 49.1 (38.0) | −1.3 (−15.8, 13.2) | −4.1 (−18.7, 10.5) |
| Family relationships | 70.7 (28.0) | 76.9 (29.3) | 74.0 (27.6) | 73.7 (29.5) | −0.3 (−11.2, 10.6) | −3.9 (−14.4, 6.6) | 69.5 (31.3) | 70.9 (32.0) | 1.4 (−11.0, 13.9) | −2.4 (−14.2, 9.5) |
| PEDI mobility score3 | 36.3 (5.9) | 35.3 (6.7) | 35.7 (7.7) | 37.2 (7.5) | 1.6 (−1.5, 4.6) | 1.5 (−1.3, 4.3) | 39.3 (6.8) | 39.7 (8.0) | 0.5 (−2.6, 3.5) | 0.4 (−2.3, 3.2) |
| Developmental quotients | ||||||||||
| Global DQ4 | 28.9 (18.5) | 31.3 (19.7) | 27.6 (19.7) | 31.7 (22.3) | 4.0 (−4.0, 12.0) | 3.0 (−4.5, 10.6) | 16.4 (13.9) | 20.4 (16.7) | 4.0 (−2.1, 10.1) | 2.4 (−2.3, 7.0) |
| Locomotor | 28.6 (23.0) | 29.8 (23.5) | 18.4 (20.4) | 21.6 (21.1) | 3.2 (−5.1, 11.5) | 3.4 (−3.4, 10.3) | 16.8 (15.1) | 18.6 (18.2) | 1.9 (−4.7, 8.5) | 1.8 (−3.8, 7.3) |
| Personal social | 33.2 (23.6) | 40.2 (27.5) | 25.9 (19.2) | 30.4 (24.7) | 4.5 (−4.2, 13.2) | 1.0 (−5.5, 7.5) | 20.4 (17.0) | 25.1 (19.9) | 4.7 (−2.6, 12.1) | 2.2 (−3.6, 8.1) |
| Speech and hearing | 36.7 (22.1) | 38.3 (23.7) | 23.2 (14.6) | 29.6 (17.0) | 6.4 (0.2, 12.7) | 6.1 (0.8, 11.4) | 18.9 (12.1) | 22.6 (14.0) | 3.8 (−1.4, 8.9) | 3.1 (−1.3, 7.4) |
| Eye and hand | 21.7 (20.2) | 23.9 (21.1) | 15.8 (18.8) | 21.4 (22.3) | 5.6 (−2.6, 13.7) | 5.2 (0.2, 10.2) | 12.6 (15.4) | 17.7 (18.8) | 5.2 (−1.6, 12.0) | 4.7 (−0.3, 9.7) |
| Performance | 21.4 (17.4) | 21.3 (16.0) | 15.4 (15.2) | 20.5 (20.0) | 5.1 (−1.9, 12.1) | 6.6 (0.9, 12.3) | 13.2 (14.6) | 16.6 (16.3) | 3.4 (−2.8, 9.5) | 4.8 (−0.1, 9.8) |
| Anthropometry5 | ||||||||||
| Weight-for-age z-score | −2.3 (1.5) | −2.5 (1.7) | −2.5 (1.8) | −2.6 (1.7) | −0.1 (−0.8, 0.6) | 0.0 (−0.5, 0.5) | −2.8 (1.5) | −3.4 (1.7) | −0.6 (−1.3, 0.0) | −0.5 (−1.0, 0.0) |
| Height-for-age z-score | −2.0 (1.6) | −2.4 (2.2) | −2.5 (1.8) | −2.9 (1.9) | −0.4 (−1.1, 0.3) | −0.3 (−0.9, 0.3) | −2.8 (1.5) | −3.2 (1.7) | −0.4 (−1.1, 0.2) | −0.3 (−0.9, 0.2) |
| HC-for-age z-score | −2.2 (2.0) | −2.2 (2.8) | −2.7 (2.5) | −2.5 (2.6) | 0.2 (−0.7, 1.2) | 0.3 (−0.4, 0.9) | −3.2 (2.3) | −3.0 (2.7) | 0.2 (−0.8, 1.2) | 0.1 (−0.5, 0.7) |
| MUAC-for-age z-score | −1.0 (1.4) | −1.1 (1.5) | −1.1 (1.4) | −1.0 (1.9) | 0.1 (−0.6, 0.8) | 0.3 (−0.2, 0.9) | −1.1 (1.2) | −1.6 (1.8) | −0.5 (−1.1, 0.1) | −0.4 (−0.9, 0.2) |
| Caregiver wellbeing | ||||||||||
| SRQ score6 | 7.0 (4.7) | 6.9 (4.7) | 7.3 (4.9) | 7.9 (5.2) | 0.6 (−1.4, 2.6) | 1.1 (−0.7, 3.0) | 8.5 (5.2) | 7.5 (4.9) | −1.0 (−3.0, 1.0) | −0.5 (−2.3, 1.3) |
| MIRI score7 | 77.3 (12.7) | 78.8 (13.6) | 80.5 (12.7) | 81.6 (12.0) | 1.1 (−4.1, 6.3) | −0.3 (−5.4, 4.7) | 82.2 (14.3) | 84.4 (12.7) | 2.2 (−3.3, 7.7) | 0.4 (−4.7, 5.5) |
| PSI score8 | 90.2 (28.0) | 90.9 (26.1) | 91.2 (26.4) | 87.6 (24.8) | −3.6 (−13.7, 6.4) | −6.8 (−15.9, 1.4) | 84.6 (29.2) | 91.7 (27.6) | 7.2 (−4.8, 19.1) | 2.8 (−7.3, 12.8) |
| HOME9 | ||||||||||
| Total score | 21.8 (4.5) | 20.0 (5.0) | 24.7 (4.8) | 22.2 (5.1) | −2.5 (−5.4, 0.5) | −1.2 (−3.7, 1.3) | ||||
| Responsivity | 5.8 (2.1) | 5.3 (2.6) | 7.0 (2.1) | 6.8 (2.2) | −0.1 (−1.4, 1.1) | −0.0 (−1.3, 1.2) | ||||
| Acceptance | 5.3 (1.1) | 5.5 (0.8) | 5.5 (0.9) | 5.5 (0.7) | 0.0 (−0.5, 0.5) | 0.0 (−0.5, 0.5) | ||||
| Organization | 3.6 (1.1) | 3.9 (1.1) | 4.6 (1.0) | 3.7 (1.3) | −0.9 (−1.6, −0.2) | −1.0 (−1.6, −0.4) | ||||
| Learning material | 2.8 (2.2) | 1.7 (1.6) | 2.6 (2.2) | 1.7 (1.3) | −0.9 (−1.9, 0.2) | −0.3 (−1.3, 0.7) | ||||
| Involvement | 2.9 (1.1) | 2.7 (1.2) | 3.3 (1.3) | 3.2 (1.2) | −0.1 (−0.9, 0.6) | 0.0 (−0.7, 0.7) | ||||
| Variety | 1.3 (1.4) | 0.9 (0.9) | 1.7 (1.0) | 1.3 (1.0) | −0.4 (−1.0, 0.2) | −0.3 (−0.9, 0.3) | ||||
PEDI, pediatric evaluation of disability inventory; HC, head circumference; MUAC, mid-upper arm circumference; SRQ, self-report questionnaire; MIRI, maternal-infant responsiveness index; PSI, parent stress index; HOME, home observation for the measurement of the environment. 1Baby Ubuntu vs. standard care (reference group). 2Adjusted for corresponding outcome assessed at baseline (before randomization). 3PEDI missing for 5 in standard care arm, 6 in Baby Ubuntu arm at 6 months and missing for 4 in standard care arm, 2 in Baby Ubuntu arm at 12 months. 4Griffiths sub-quotient scores missing for 3 in standard care arm, 2 in Baby Ubuntu arm at baseline and missing for 4 in standard care arm and 4 in Baby Ubuntu arm at 6 months. 5Anthropometry missing for 1 in Baby Ubuntu arm at 12 months, z-scores below −6 were imputed to have value −6. 6SRQ missing for 5 in standard care arm, 7 in Baby Ubuntu arm at 6 months and missing for 1 in standard care arm at 12 months. 7MIRI missing for 9 in standard care, 11 in Baby Ubuntu arm at 6 months and missing for 3 in standard care arm, 3 in Baby Ubuntu arm at 12 months. 8PSI missing for 5 in standard care arm, 2 in Baby Ubuntu arm at 6 months and missing for 4 in standard care arm, 7 in Baby Ubuntu arm at 12 months. 9HOME done for 27 at baseline and 24 at 12 months in standard care, done for 23 at baseline and 22 at 12 months in Baby Ubuntu arm, not done at 6 months.