Table 2

Outcomes at 9 months: by treatment as allocated and per protocol

ControlIntervention
Outcomesn*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 allocatedEffect size (95% CI), p value †‡per protocol analysis
Primary outcomes
 Negative parenting10611.04 (10.27)1.41 (0.96)11510.72 (11.62)2.31 (1.02)0.90 (−1.90 to 3.69), 0.521.52 (−1.58 to4.61),0.34
 Supportive parenting10626.04 (2.75)0.38 (0.27)11525.82 (3.00)0.55 (0.28)0.17 (−0.61 to 0.94), 0.670.43 (−0.44 to 1.30), 0.33
Secondary outcomes
 SF-121100.67 (0.09)0.01 (0.01)1210.68 (0.08)0.02 (0.07)0.01 (−0.01 to 0.02), 0.600.01 (−0.02 to 0.03), 0.69
 Parenting Stress Index99123.33 (21.49)5.88 (1.78)106124.13 (22.39)5.08 (1.72)−0.80 (−5.74 to 4.14), 0.752.88 (−2.78 to 8.54), 0.32
 PedQL11258.60 (8.90)−0.20 (0.81)11858.51 (7.87)1.30 (0.80)1.50 (−0.74 to 3.74), 0.191.10 (−1.37 to 3.56), 0.38
 WEMWBS score11340.61 (9.01)2.53 (0.81)12139.54 (9.71)3.03 (0.83)0.49 (−1.82 to 2.80), 0.672.02 (−0.56 to 4.59), 0.13
PrePACS
 Hscale (weekly)11411.70 (6.68)2.57 (0.66)12912.14 (6.84)3.43 (0.63)0.86 (−0.95 to 2.66), 0.351.61 (−0.46 to 3.67), 0.13
 Hscale (typical)11513.78 (7.02)2.62 (0.69)12913.41 (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)11616.09 (8.38)1.23 (0.83)12816.07 (9.45)1.27 (1.01)0.03 (−2.57 to 2.64), 0.981.94 (−0.77 to 4.65), 0.16
 Cscale (typical)11616.58 (8.39)1.50 (0.79)12716.07 (9.94)1.38 (0.88)−0.12 (−2.47 to 2.24),0.921.29 (−1.27 to 3.84),0.32
 Internalising (Freq)1105.66 (3.43)0.26 (0.33)1225.44 (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)1105.46 (3.73)0.39 (0.42)1265.18 (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)1076.30 (1.38)0.29 (0.14)1246.48 (1.30)0.30 (0.14)0.01 (−0.39 to 0.40), 0.970.14 (−0.30 to 0.58),0.54
 5 min speech sample (% negative comments)1050.43 (0.26)0.07 (0.03)1170.41 (0.27)0.05 (0.03)−0.01 (−0.10 to 0.07), 0.750.06 (−0.03 to 0.15), 0.21
Meal-time video
 Proportion of negative interactions840.12 (0.16)−0.02 (0.02)870.14 (0.15)0.03 (0.02)0.05 (−0.01to 0.11), 0.130.03 (−0.04 to 0.10), 0.41
 Rate of negative interactions (length)840.49 (0.73)−0.02 (0.10)870.52 (0.72)0.09 (0.10)0.11 (−0.19 to 0.40), 0.460.09 (−0.23 to 0.41), 0.59
 Rate of positive interactions (length)843.65 (2.57)−0.14 (0.46)873.13 (2.24)0.62 (0.46)0.75 (−0.53 to 2.04), 0.250.56 (−0.87 to 1.99), 0.44
 Rate of negative interactions (involvement)720.68 (0.96)−0.19 (0.19)730.72 (0.86)−0.16 (0.19)0.03 (−0.50 to 0.57), 0.910.07 (−0.52 to 0.66), 0.82
 Rate of positive interactions (involvement)724.99 (3.19)0.93 (1.01)734.66 (2.87)2.55 (1.01)1.62 (−1.21 to 4.45), 0.261.16 (−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.