Abstract
Social emotional development in infancy is a predictor of outcomes in later life, yet there is little evidence of effectiveness for parenting interventions designed to enhance social emotional wellbeing in infancy. An 18-month two-arm randomized controlled pilot trial evaluated the feasibility of a definitive trial of Incredible Years (IY) Infant and Toddler parent programs delivered in a proportionate universal model, called Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE) Steps. Intervention families received an IY Babies book (universal dose), followed by the IY Infant and/or the Toddler group-based programs, based on parent depression (PHQ-9) and/or child social emotional development (ASQ:SE-2) scores. Control parents received services as usual. Parents from two English local authorities with a child eight-weeks-old or younger participated, and were block randomized using a web-based system. Primary endpoints for the study were feasibility parameters relating to recruitment, retention, intervention fidelity and appropriateness of measures. 205 participants were randomized (152:53, intervention:control). Our target was 288 parents. Trial retention rate was higher than expected, with a completion rate of 88% (n = 181, 137:44) at follow-up 3; equating to 94% of 192 expected participants. Intervention uptake was lower than expected. Fidelity of delivery was acceptable and measures were deemed appropriate. A definitive trial is feasible with design amendments to include: introduction of a child screener for intervention eligibility; enhanced intervention material; revised sample size and random allocation ratio. Our internal pilot became an external pilot due to these changes.
Highlights
The lower than expected proportion of parents with depression symptoms in the sample reduced the number of parents eligible for the Incredible Years (IY)-I and IY-T program at follow-up 1 (FU1) and follow-up 2 (FU2). Because of this we reduced the threshold for eligibility to IY-I and IY-T from 5 to 4 for the pilot, this was designed as a temporary strategy to ensure that there were enough eligible participants to enable the piloting of group delivery processes
There were initial barriers around participant identification and recruitment, for example, participant identification began the week that commissioning for health visiting (HV) in England moved from the NHS to Local Authorities
Senior site management were fully committed to the trial, health visitors faced a lot of uncertainty and had limited capacity which may have led to reduced identification and recruitment
Summary
The study’s main aim was to establish if a definitive RCT of E-SEE STEPS is feasible. Progression criteria (see Table 1) were set in relation to: (a) recruitment; (b) retention; (c) intervention delivery; (d) intervention acceptability; and (e) intervention fidelity. The secondary objective was to gather data to inform a statistical power and sample size calculation for a main trial to answer the primary research question, i.e., “to what extent does the proportionate delivery model of IY (and each dose level) enhance child social emotional well-being at 20 months of age and adult well-being compared to services as usual?” Pilot data was required to estimate: (a) the variability in the primary outcome (ASQ:SE-2) of each arm at follow-up timepoints; (b) the correlation between the primary clinical outcome at different timepoints; (c) the pooled standard deviation (SD) of the primary outcome at follow-up timepoints; (d) the average group size attending IY-I and IY-T; (e) the prevalence of mild to severe parent depression at all timepoints; and (f) the prevalence of ASQ:SE-2 monitoring levels at all timepoints
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