The protocol article for TIGA-CUB (Trial on Improving Inter-Generational Attachment for Children Undergoing Behaviour problems) has been published in Trials and is available as an open access article free of charge at the following link: http://rdcu.be/vTEz
The results of this small scale feasibility trial will be published once they become available, and there is a plan to apply for funding for a large scale, confirmatory trial if the feasibility results are sufficient to meet the progression criteria.
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 and adolescent psychotherapy versus 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 has recruited 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 completed assessments at baseline (prior to randomisation) and again at 4 months. The trial aimed 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, remained open for an eight month period, and aimed to recruit up to 60 participants (children and their primary carers) from Trusts in Yorkshire and the West Midlands. Trial results are anticipated by January 2018.
Dr Elizabeth Edginton
Leeds and York Partnerships NHS Foundation Trust
Leeds Institute of Clinical Trials Research
University of Leeds
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