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

Not Applicable

Completed

• Conditions: Prevention of parental distress resulting in child conduct and behavioural disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN16150114
• Lead Sponsor: Bradford Teaching Hospitals NHS Foundation Trust

Brief Summary

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38291514/ (added 31/01/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-12
• Study Completion: 2023-12-31
• Last Update Posted: 12 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

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 Have not withdrawn consent to the BiBBS cohort at the time of randomisation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

Not currently enrolled in the BiBBS cohort study

Study & Design

• Study Type: Interventional
• Study Design: Not specified