Is it feasible to nest a Trial within a Cohort Study (TwiCS) to evaluate an early years parenting programme? A Born in Bradford?s Better Start study protocol

Evaluating the effectiveness of early years parenting interventions provides evidence to improve the development and wellbeing of children.

The study aims to use a Trial Within a Cohort Study (TwiCS) design, which randomly selects individuals participating in a cohort to be offered an intervention. The cohort is the Born in Bradford’s Better Start (BiBBS) cohort, an interventional birth cohort recruiting expectant parents in three areas of Bradford, UK. The intervention is the Incredible Years Toddler (IY-T) programme, a group-based parent education programme for parents of children aged 1-3 years (The Incredible Years, 2013). The study will assess the feasibility of TwiCS procedures, staged consent, and intervention take-up.

We will conduct a feasibility TwiCS to test study procedures. We aim to establish: (1) whether TwiCS methodology can be implemented to create control and intervention arms; (2) whether satisfactory rates of intervention uptake are achieved among participants allocated to the intervention; and (3) whether satisfactory rates of retention of participants in the intervention can be achieved.

Eligible participants in the BiBBS cohort will be individually randomised 1:1 to the intervention or control arms. BiBBS researchers will seek consent from participants randomised to the intervention to pass their contact details onto Incredible Years’ delivery agents.

Overall, this feasibility study will inform the utility of the TwiCs approach within an experimental birth cohort to evaluate interventions for infants, toddlers, and their families.