Table 2. Summary statistics and results from linear regression model analysis of primary and infants’ secondary outcomes (n=250).
| Primary and secondary outcomes | Visit | Intervention (n=125) | Treatment as usual (n=125) |
Difference in least squares mean (95% CI) | P value | Effect size | ||
|---|---|---|---|---|---|---|---|---|
| N | M (SD) | N | M (SD) | |||||
| Observation of Mother and Child Interaction (OMCI) | ||||||||
| OMCI Total Score | 12 months | 105 | 42.05 (8.65) | 101 | 29.74 (8.19) | 12.31 (9.99 to 14.62) | <0.0001 | 1.46 (1.19 to 1.74) |
| Mother’s behaviour | 12 months | 105 | 28.80 (5.43) | 101 | 20.16 (5.41) | 8.64 (7.15 to 10.13) | <0.0001 | 1.59 (1.32 to 1.87) |
| Child’s behaviour | 12 months | 105 | 13.25 (3.84) | 101 | 9.58 (3.50) | 3.66 (2.65 to 4.67) | <0.0001 | 1.00 (0.72 to 1.27) |
| Bayley’s Scales of Infant Development (BSID III)—raw scores | ||||||||
| Cognitive | 12 months | 104 | 50.12 (4.27) | 100 | 48.46 (5.56) | 1.66 (0.29 to 3.02) | 0.0178 | 0.34 (0.06 to 0.61) |
| Receptive language | 12 months | 104 | 14.50 (2.87) | 100 | 13.99 (2.57) | 0.51 (−0.24 to 1.26) | 0.1831 | 0.19 (-0.09 to 0.46) |
| Expressive Language | 12 months | 104 | 17.01 (2.96) | 100 | 16.41 (5.23) | 0.60 (−0.57 to 1.77) | 0.3123 | 0.15 (-0.14 to 0.43) |
| Fine motor | 12 months | 104 | 29.48 (1.49) | 100 | 29.26 (2.93) | 0.22 (-0.42 to 0.86) | 0.4964 | 0.10 (-0.19 to 0.39) |
| Gross motor | 12 months | 104 | 43.84 (3.34) | 100 | 43.92 (3.03) | −0.08 (-0.96 to 0.80) | 0.852 | −0.03 (-0.30 to 0.25) |
| Social emotional | 12 months | 104 | 75.96 (15.29) | 100 | 67.22 (12.22) | 8.74 (4.91 to 12.57) | <0.0001 | 0.64 (0.36 to 0.91) |
| Adaptive functioning | 12 months | 103 | 31.73 (7.06) | 100 | 28.81 (6.26) | 2.92 (1.07 to 4.77) | 0.0021 | 0.44 (0.16 to 0.72) |
| Adaptive functioning— community use | 12 months | 103 | 10.95 (7.04) | 100 | 9.54 (5.72) | 1.41 (-0.37 to 3.19) | 0.1189 | 0.22 (-0.06 to 0.50) |
| Adaptive functioning— Functional Pre-Academics | 12 months | 103 | 5.84 (1.78) | 100 | 4.77 (1.84) | 1.07 (0.57 to 1.58) | <0.0001 | 0.59 (0.32 to 0.87) |
| Adaptive functioning—home living | 12 months | 103 | 19.64 (11.16) | 100 | 16.50 (9.77) | 3.14 (0.23 to 6.05) | 0.0343 | 0.30 (0.02 to 0.58) |
| Adaptive functioning—health safety | 12 months | 103 | 26.26 (7.85) | 100 | 23.62 (7.43) | 2.64 (0.53 to 4.76) | 0.0147 | 0.35 (0.07 to 0.62) |
| Adaptive functioning—leisure | 12 months | 103 | 26.37 (6.34) | 100 | 23.93 (5.64) | 2.44 (0.78 to 4.10) | 0.0042 | 0.41 (0.13 to 0.68) |
| Adaptive functioning—self-care | 12 months | 103 | 32.19 (5.99) | 100 | 29.98 (4.99) | 2.21 (0.69 to 3.74) | 0.0047 | 0.40 (0.12 to 0.68) |
| Adaptive functioning—self direction | 12 months | 103 | 25.71 (6.55) | 100 | 23.31 (5.56) | 2.40 (0.71 to 4.08) | 0.0055 | 0.40 (0.12 to 0.67) |
| Adaptive functioning—social | 12 months | 103 | 30.00 (3.45) | 100 | 28.25 (3.48) | 1.75 (0.79 to 2.71) | 0.0004 | 0.51 (0.23 to 0.78) |
| Adaptive functioning—motor | 12 months | 103 | 46.12 (9.34) | 100 | 44.55 (8.15) | 1.57 (−0.86 to 4.00) | 0.205 | 0.18 (-0.10 to 0.46) |
| Home Inventory | ||||||||
| HOME total scores | 12 months | 105 | 38.06 (4.61) | 100 | 33.95 (5.65) | 4.11 (2.69 to 5.52) | <0.0001 | 0.80 (0.52 to 1.08) |
| Home responsivity | 12 months | 105 | 9.92 (1.41) | 100 | 8.70 (1.86) | 1.22 (0.77 to 1.68) | <0.00001 | 0.75 (0.47 to 1.03) |
| Home acceptance | 12 months | 105 | 6.77 (1.22) | 100 | 5.46 (1.95) | 1.31 (0.87 to 1.76) | <0.0001 | 0.83 (0.55 to 1.11) |
| Anthropometric measurements | ||||||||
| Weight of the child (in kg) | At birth | 95 | 2.28 (1.53) | 95 | 1.50 (1.79) | 0.78 (0.30 to 1.25) | 0.0015 | 0.47 (0.18 to 0.76) |
| HAZ | 12 months | 105 | −0.48 (1.76) | 101 | −0.45 (1.49) | −0.03 (−0.48 to 0.42) | 0.8956 | −0.02 (-0.29 to 0.26) |
| WAZ | 12 months | 105 | −0.45 (1.26) | 101 | −0.59 (1.37) | 0.14 (-0.22 to 0.50) | 0.4436 | 0.11 (-0.17 to 0.38) |
Effect size was calculated as Cohen’s d, based on the adjusted mean difference divided by the estimated pooled SD.
ASQ-3 comparisons with a total sample size of fewer than 80 participants across the two treatment groups were excluded because the small sample sizes limited the interpretability of the comparisons.
.HAZ, height-for-age z-score; M, mean; SD, standard deviation; TAU, Treatment as usual; WAZ, weight-for-age z-score.