TIGA-CUB – manualised psychoanalytic child psychotherapy versus treatment as usual for children aged 5–11 years with treatment-resistant conduct disorders and their primary carers: study protocol for a randomised controlled feasibility trial

Edginton, Elizabeth; Walwyn, Rebecca; Burton, Kayleigh; Cicero, Robert; Graham, Liz; Reed, Sadie; Tubeuf, Sandy; Twiddy, Maureen; Wright-Hughes, Alex; Ellis, Lynda; Evans, Dot; Hughes, Tom; Midgley, Nick; Wallis, Paul; Cottrell, David

Abstract

Background: The National Institute for Health and Care Excellence (NICE) recommends evidence-based parenting
programmes as a first-line intervention for conduct disorders (CD) in children aged 5–11 years. As these are not
effective in 25–33% of cases, NICE has requested research into second-line interventions. Child and Adolescent
Psychotherapists (CAPTs) address highly complex problems where first-line treatments have failed and there have
been small-scale studies of Psychoanalytic Child Psychotherapy (PCP) for CD. A feasibility trial is needed to
determine whether a confirmatory trial of manualised PCP (mPCP) versus Treatment as Usual (TaU) for CD is
practicable or needs refinement. The aim of this paper is to publish the abridged protocol of this feasibility trial.
Methods and design: TIGA-CUB (Trial on improving Inter-Generational Attachment for Children Undergoing
Behaviour problems) is a two-arm, pragmatic, parallel-group, multicentre, individually randomised (1:1) controlled
feasibility trial (target n = 60) with blinded outcome assessment (at 4 and 8 months), which aims to develop an
optimum practicable protocol for a confirmatory, pragmatic, randomised controlled trial (RCT) (primary outcome:
child’s behaviour; secondary outcomes: parental reflective functioning and mental health, child and parent quality
of life), comparing mPCP and TaU as second-line treatments for children aged 5–11 years with treatment-resistant
CD and inter-generational attachment difficulties, and for their primary carers. Child-primary carer dyads will be
recruited following a referral to, or re-referral within, National Health Service (NHS) Child and Adolescent Mental
Health Services (CAMHS) after an unsuccessful first-line parenting intervention. PCP will be delivered by qualified
CAPTs working in routine NHS clinical practice, using a trial-specific PCP manual (a brief version of established PCP
clinical practice). Outcomes are: (1) feasibility of recruitment methods, (2) uptake and follow-up rates, (3) therapeutic
delivery, treatment retention and attendance, intervention adherence rates, (4) follow-up data collection, and
(5) statistical, health economics, process evaluation, and qualitative outcomes.
Discussion: TIGA-CUB will provide important information on the feasibility and potential challenges of undertaking
a confirmatory RCT to evaluate the effectiveness and cost-effectiveness of mPCP.

Citation

Edginton, E., Walwyn, R., Burton, K., Cicero, R., Graham, L., Reed, S., Tubeuf, S., Twiddy, M., Wright-Hughes, A., Ellis, L., Evans, D., Hughes, T., Midgley, N., Wallis, P., & Cottrell, D. (2017). TIGA-CUB – manualised psychoanalytic child psychotherapy versus treatment as usual for children aged 5–11 years with treatment-resistant conduct disorders and their primary carers: study protocol for a randomised controlled feasibility trial. Trials, 18(1), Article 431. https://doi.org/10.1186/s13063-017-2166-2

• Journal Article Type: Article
• Acceptance Date: Aug 30, 2017
• Online Publication Date: Sep 15, 2017
• Publication Date: Sep 15, 2017
• Deposit Date: Jan 5, 2018
• Publicly Available Date: Jan 15, 2018
• Journal: Trials
• Print ISSN: 1745-6215
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• Volume: 18
• Issue: 1
• Article Number: 431
• DOI: https://doi.org/10.1186/s13063-017-2166-2
• Keywords: Medicine (miscellaneous); Pharmacology (medical)
• Public URL: https://hull-repository.worktribe.com/output/499584
• Publisher URL: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2166-2
• Contract Date: Jan 5, 2018