Outcomes at 3 months: by treatment as allocated and per protocol
| Control | Intervention | |||||||
|---|---|---|---|---|---|---|---|---|
| Outcomes | n* | Baseline score (SD) | Change at 9 months (SE) | n* | Baseline score (SD) | Change at 9 months (SE) | Effect size (95% CI), p value† analysis by treatment allocated | Effect size (95% CI), p value †‡ per protocol analysis |
| SF-12 | 115 | 0.66 (0.09) | 0.01 (0.01) | 125 | 0.68 (0.08) | 0.01 (0.01) | −0.01 (−0.02 to 0.02), 0.88 | −0.01 (−0.03 to 0.01), 0.38 |
| Parenting Stress Index | 108 | 123.12 (22.22) | 0.99 (1.65) | 103 | 124.55 (23.37) | 3.99 (1.69) | 3.00 (−1.66 to 7.66), 0.21 | −1.27 (−6.69 to 4.14), 0.64 |
| PedQL | 128 | 58.44 (9.06) | −0.48 (0.77) | 116 | 59.15 (7.13) | 0.21 (0.83) | 0.69 (−1.55 to 2.92), 0.55 | 1.31 (−1.28 to 3.89), 0.32 |
| WEMWBS score | 128 | 40.70 (9.45) | 0.85 (0.78) | 117 | 39.85 (9.88) | 2.26 (0.99) | 1.41 (−1.12 to 3.93), 0.27 | 1.11 (−1.60 to 3.82), 0.42 |
*Corresponds to number of children included in the analysis.
†The effect size is the difference between difference in control and intervention groups with a positive value indicating the intervention is superior to control and vice versa.
‡The per protocol analysis gives the results comparing outcomes for families that did not attend any FLNP session to outcomes for families that attended six or more sessions. Group numbers varied for measures: SF-12, control group n=145, intervention group n=63; Parenting Stress Index, control group n=125, intervention group n=57; PedQL, control group n=146, intervention group n=68; WEMWBS score, control group n=149, intervention group n=62.
FLNP, Family Links Nurturing Programme; WEMWBS, Warwick-Edinburgh Mental Well-being Scale.