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 |
Primary outcomes | ||||||||
Negative parenting | 106 | 11.04 (10.27) | 1.41 (0.96) | 115 | 10.72 (11.62) | 2.31 (1.02) | 0.90 (−1.90 to 3.69), 0.52 | 1.52 (−1.58 to4.61),0.34 |
Supportive parenting | 106 | 26.04 (2.75) | 0.38 (0.27) | 115 | 25.82 (3.00) | 0.55 (0.28) | 0.17 (−0.61 to 0.94), 0.67 | 0.43 (−0.44 to 1.30), 0.33 |
Secondary outcomes | ||||||||
SF-12 | 110 | 0.67 (0.09) | 0.01 (0.01) | 121 | 0.68 (0.08) | 0.02 (0.07) | 0.01 (−0.01 to 0.02), 0.60 | 0.01 (−0.02 to 0.03), 0.69 |
Parenting Stress Index | 99 | 123.33 (21.49) | 5.88 (1.78) | 106 | 124.13 (22.39) | 5.08 (1.72) | −0.80 (−5.74 to 4.14), 0.75 | 2.88 (−2.78 to 8.54), 0.32 |
PedQL | 112 | 58.60 (8.90) | −0.20 (0.81) | 118 | 58.51 (7.87) | 1.30 (0.80) | 1.50 (−0.74 to 3.74), 0.19 | 1.10 (−1.37 to 3.56), 0.38 |
WEMWBS score | 113 | 40.61 (9.01) | 2.53 (0.81) | 121 | 39.54 (9.71) | 3.03 (0.83) | 0.49 (−1.82 to 2.80), 0.67 | 2.02 (−0.56 to 4.59), 0.13 |
PrePACS | ||||||||
Hscale (weekly) | 114 | 11.70 (6.68) | 2.57 (0.66) | 129 | 12.14 (6.84) | 3.43 (0.63) | 0.86 (−0.95 to 2.66), 0.35 | 1.61 (−0.46 to 3.67), 0.13 |
Hscale (typical) | 115 | 13.78 (7.02) | 2.62 (0.69) | 129 | 13.41 (7.49) | 2.58 (0.82) | −0.03 (−2.18 to 2.12), 0.98 | −0.06 (−2.29 to 2.18), 0.96 |
Cscale (weekly) | 116 | 16.09 (8.38) | 1.23 (0.83) | 128 | 16.07 (9.45) | 1.27 (1.01) | 0.03 (−2.57 to 2.64), 0.98 | 1.94 (−0.77 to 4.65), 0.16 |
Cscale (typical) | 116 | 16.58 (8.39) | 1.50 (0.79) | 127 | 16.07 (9.94) | 1.38 (0.88) | −0.12 (−2.47 to 2.24),0.92 | 1.29 (−1.27 to 3.84),0.32 |
Internalising (Freq) | 110 | 5.66 (3.43) | 0.26 (0.33) | 122 | 5.44 (3.19) | 0.40 (0.34) | 0.13 (−0.82 to 1.09), 0.78 | −0.08 (−1.16 to 1.00), 0.89 |
Internalising (reassure) | 110 | 5.46 (3.73) | 0.39 (0.42) | 126 | 5.18 (3.68) | 0.10 (0.40) | −0.29 (−1.43 to 0.85), 0.62 | −1.02 (−2.34 to 0.30), 0.13 |
5 min speech sample (warmth of opening statements) | 107 | 6.30 (1.38) | 0.29 (0.14) | 124 | 6.48 (1.30) | 0.30 (0.14) | 0.01 (−0.39 to 0.40), 0.97 | 0.14 (−0.30 to 0.58),0.54 |
5 min speech sample (% negative comments) | 105 | 0.43 (0.26) | 0.07 (0.03) | 117 | 0.41 (0.27) | 0.05 (0.03) | −0.01 (−0.10 to 0.07), 0.75 | 0.06 (−0.03 to 0.15), 0.21 |
Meal-time video | ||||||||
Proportion of negative interactions | 84 | 0.12 (0.16) | −0.02 (0.02) | 87 | 0.14 (0.15) | 0.03 (0.02) | 0.05 (−0.01to 0.11), 0.13 | 0.03 (−0.04 to 0.10), 0.41 |
Rate of negative interactions (length) | 84 | 0.49 (0.73) | −0.02 (0.10) | 87 | 0.52 (0.72) | 0.09 (0.10) | 0.11 (−0.19 to 0.40), 0.46 | 0.09 (−0.23 to 0.41), 0.59 |
Rate of positive interactions (length) | 84 | 3.65 (2.57) | −0.14 (0.46) | 87 | 3.13 (2.24) | 0.62 (0.46) | 0.75 (−0.53 to 2.04), 0.25 | 0.56 (−0.87 to 1.99), 0.44 |
Rate of negative interactions (involvement) | 72 | 0.68 (0.96) | −0.19 (0.19) | 73 | 0.72 (0.86) | −0.16 (0.19) | 0.03 (−0.50 to 0.57), 0.91 | 0.07 (−0.52 to 0.66), 0.82 |
Rate of positive interactions (involvement) | 72 | 4.99 (3.19) | 0.93 (1.01) | 73 | 4.66 (2.87) | 2.55 (1.01) | 1.62 (−1.21 to 4.45), 0.26 | 1.16 (−1.98 to 4.29), 0.47 |
*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 that 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: negative parenting, control group, n=128, intervention group n=62; supportive parenting, control group n=128, intervention group n=62; SF-12, control group n=134, intervention group n=62; Parenting Stress Index, control group n=120, intervention group n=56; PedQL, control group n=133, intervention group n=68; WEMWBS score, control group n=136, intervention group n=64; Hscale (weekly), control group, n=140, intervention group n=68; Hscale (typical), control group, n=141, intervention group n=68; Cscale (weekly), control group n=142, intervention group n=68; Cscale (typical), control group n=142, intervention group n=67; internalising (Freq), control group n=133, intervention group n=65; internalising (reassure), control group n=138, intervention group n=66; 5-min speech sample (warmth of opening statements), control group n=129, intervention group n=69; 5-min speech sample (% negative comments), control group n=124, intervention group n=68; proportion of negative interactions, control group n=94, intervention group n=55; rate of negative interactions (length), control group n=94, intervention group n=55; rate of positive interactions (length), control group n=94, intervention group n=55; rate of negative interactions (involvement), control group n=78, intervention group n=48; rate of positive interactions (involvement), control group n=78, intervention group n=48.
FLNP, Family Links Nurturing Programme; PrePACS, preschool Parent Account of Child Symptoms; WEMWBS, Warwick-Edinburgh Mental Well-being Scale.