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

A feasibility ‘trial within a cohort study’ (TWiCS) of the 'Incredible Years Toddler' parenting programme: a Born in Bradford’s Better Start cohort sub-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16150114
Enrollment
240
Registered
2023-05-12
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of parental distress resulting in child conduct and behavioural disorder Mental and Behavioural Disorders

Interventions

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

Sponsors

Bradford Teaching Hospitals NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 Have not withdrawn consent to the BiBBS cohort at the time of randomisation 3.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

Exclusion criteria

Exclusion criteria: Not currently enrolled in the BiBBS cohort study

Design outcomes

Primary

MeasureTime frame
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 t

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

England, United Kingdom

Contacts

Public ContactKate Mooney
kate.mooney@york.ac.uk+44 (0)1904 321312

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026