A randomized controlled trial of a proportionate universal parenting program delivery model (E-SEE Steps) to enhance child social-emotional wellbeing.

BACKGROUND

Evidence for parenting programs to improve wellbeing in children under three is inconclusive. We investigated the fidelity, impact, and cost-effectiveness of two parenting programs delivered within a longitudinal proportionate delivery model ('E-SEE Steps').

METHODS

Eligible parents with a child ≤ 8 weeks were recruited into a parallel two-arm, assessor blinded, randomized controlled, community-based, trial with embedded economic and process evaluations. Post-baseline randomization applied a 5:1 (intervention-to-control) ratio, stratified by primary (child social-emotional wellbeing (ASQ:SE-2)) and key secondary (maternal depression (PHQ-9)) outcome scores, sex, and site. All intervention parents received the Incredible Years® Baby Book (IY-B), and were offered the targeted Infant (IY-I)/Toddler (IY-T) program if eligible, based on ASQ:SE-2/PHQ-9 scores. Control families received usual services. Fidelity data were analysed descriptively. Primary analysis applied intention to treat. Effectiveness analysis fitted a marginal model to outcome scores. Cost-effectiveness analysis involved Incremental Cost-Effectiveness Ratios (ICERs).

RESULTS

The target sample (N = 606) was not achieved; 341 mothers were randomized (285:56), 322 (94%) were retained to study end. Of those eligible for the IY-I (n = 101), and IY-T (n = 101) programs, 51 and 21 respectively, attended. Eight (of 14) groups met the 80% self-reported fidelity criteria. No significant differences between arms were found for adjusted mean difference scores; ASQ:SE-2 (3.02, 95% CI: -0.03, 6.08, p = 0.052), PHQ-9 (-0.61; 95% CI: -1.34, 0.12, p = 0.1). E-SEE Steps had higher costs, but improved mothers' Health-related Quality of Life (0.031 Quality Adjusted Life Year (QALY) gain), ICER of £20,062 per QALY compared to control. Serious adverse events (n = 86) were unrelated to the intervention.

CONCLUSIONS

E-SEE Steps was not effective, but was borderline cost-effective. The model was delivered with varying fidelity, with lower-than-expected IY-T uptake. Changes to delivery systems and the individual programs may be needed prior to future evaluation.

TRIAL REGISTRATION

International Standard Randomized Controlled Trial Number: ISRCTN11079129.

Déclaration de conflit d'intérêts

All authors were supported by the grant, National Institute for Health Research (NIHR) Public Health Research (PHR) (ref 13/93/10). TB, SB, KP and GR were also supported by the NIHR Yorkshire and Humber Applied Research Collaboration (ARC-YH; Ref: NIHR200166, see https://www.arc-yh.nihr.ac.uk,); VB by the South West Peninsula ARC (PenARC, Ref: NIHR200167, see https://arc-swp.nihr.ac.uk). Public Health England supported research sites’ excess treatment costs (no award number). This above funding does not alter our adherence to PLOS ONE policies on sharing data and materials. In addition, TB is a voluntary Trustee for Children’s Early Intervention Trust (CEIT). Early Intervention Wales Training (EIWT) is owned by CEIT and offers training courses, including Incredible Years® (IY). Trustees do not benefit financially from trainings or CEIT/EIWT activities. ESEE study trainings were arranged via the IY developer in the U.S., not via EIWT.