Ongoing

Trial on Improving Inter-Generational Attachment for Children Undergoing Behaviour problems (TIGA -CUB)

TIGA-CUB is an NIHR Research for Patient Benefit-funded pragmatic, individually-randomised, controlled feasibility trial that aims to test the feasibility and acceptability of running a large scale RCT of manualised Child Psychotherapy vs. usual treatment for children with treatment resistant conduct disorders. The child psychotherapy manual was written by Child Psychotherapists at the Northern School of Child and Adolescent Psychotherapy (NSCAP).

The trial will recruit children (aged 5-11) and their primary carers presenting to Child and Adolescent Mental Health Services (CAMHS) who have had an unsuccessful first-line group or individual parenting programme or other structured parenting intervention. Primary carers will complete assessments at baseline (prior to randomisation) and again at 4 months. The trial aims to establish procedures for screening and recruitment, assess acceptability of randomisation to clinicians and primary carers, assess feasibility and best methods for data collection, assess data return rates, identify the most appropriate way to assess cost effectiveness and quality of life, establish feasibility of maintaining researcher blinding, and establish procedures for monitoring adherence to the treatment manual. Data will also inform sample size calculations for the main trial.

The trial commenced recruitment in September 2016, and will remain open for an eight month period, to recruit 60 participants (children and their primary carers) from Trusts in Yorkshire and the West Midlands. Trial results are anticipated by January 2018.

Collaborators

Chief Investigator, Dr Elizabeth Edginton,Leeds and York Partnerships NHS Foundation Trust Trial Manager, Sadie Reed, Leeds Institute of Clinical Trials Research, University of Leeds