Testing the feasibility of applying a ‘trial within a cohort study’ (TWiCS) to evaluate a programme for parents of toddlers

INTERVENTION: This study will assess the feasibility of a Trial Within a Cohort Study (TWiCS) evaluation of the Incredible Years Toddler (IY‐T) programme using BiBBS cohort participants. Eligible participants in the BiBBS cohort will be individually randomised 1:1 to the intervention (n = 120) or control group (n = 120), using blocked randomisation with stratification by child age (1 year or 2 years at the time of randomisation) and ethnicity (White British, South Asian, or other). The si Xallocation sequences (one for each stratum) will be generated using Stata/SE v17.0 (for Windows 64‐bit x86‐64) or later, using the user‐written Stata command ralloc. Within Incredible Years Toddler (IY‐T), parents learn how to help their toddlers feel loved and secure, encourage social and emotional development, and establish strategies for developing routines, handling separation, and managing misbehaviour (The Incredible Years, 2013). Parents/carers receive three promotional contacts prior to the beginning of the group via assertive outreach, consisting of telephone contact and at least one home visit. The initial telephone contact introduces the parents to the project and Group Facilitators and aims to build the participants' confidence in attending. The home visits are intended to create a sense of rapport between the family and Group Facilitators and alleviate any barriers that families might have in accessing the group such as crèche, language difficulties or concerns about what the group might involve. For more detail on the content and delivery of the IY‐T intervention, please see the online information and materials here: https://incredibleyears.com/programs/. The IY‐T theory of change and logic model dev CONDITION: Prevention of parental distress resulting in child conduct and behavioural disorder ; Mental and Behavioural Disorders SECONDARY OUTCOME: There are no secondary outcome measures INCLUSION CRITERIA: Pregnant mothers are eligible for recruitment to BiBBS if they are living in the BSB area and are registered to give birth at Bradford Teaching Hospital NHS Foundation Trust (BTHFT) (see Dickerson et al., 2016 for further details). For this feasibility TWiCs of IY‐T, caregivers will be eligible if they: 1. Provided consent to BiBBS cohort study and agreed to be contacted for future research 2. Have not withdrawn consent to the BiBBS cohort at the time of randomisation 3. Are still living in the BSB area at the time of randomisation 4. Have one or more BIBBS child(ren) aged between 12 and 36 months at the time of randomisation 5. NHS tracing confirms that their child is still living with them, and is alive 6. Have not already received IY‐T in the BSB area for any of their children PRIMARY OUTCOME: ; The primary outcomes are feasibility outcome targets which will all be measured after recruitment and the intervention have completed. Please note that an ‘enrollee’ is referred and seen face to face in at least one pre‐course contact, a ‘participant’ is someone who attends at least 1 week of the groups, and a ‘completer’ is someone that attends at least 8 of the 13 group‐based sessions. A RAG rating/traffic light system has been applied to support the feasibility assessment of each objective: to be rated as green (achieved), amber (partly achieved) and red (not achieved). For an objective to be achieved and rated green, it must reach the percentage level specified above (e.g. 70% for contactable women, 50% for converting randomised participants into referrals). The levels at which we reach amber are equal to the green target, minus 20%. This is with the exception of the rate for contamination (outcome 2), where the rates are set on achieving less than 1% contamination. The outcomes are:; ; 1. Feasibility of randomisation pathways (intervention): Successfully contact 70% of participants who were randomised to the intervention; 2. Describe any incidences of contamination: Describe any incidences of contamination between the control and intervention allocations, and successfully create intervention and control participants with minimal contamination (<1% crossover across both groups); 3. Retention to intervention (referral consent): Convert 50% of contactable parents into referrals into Incredible Years; 4. Retention to intervention (enrolees): Convert at least 50% of the participants who accept the randomised referral into enrollees in Incredible Years; 5. Retention to intervention (participants): Convert at least 90% of the participants who enrol in Incredible Years into participants; 6. Retention to intervention (completers): Convert at least 60% of the participants who enrol in Incredible Years into completers in Incredible Years; ; All outcomes will be recorded up until the end of December 2023;