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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

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

Published in: Trials | Issue 1/2017

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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.

Trial registration

Current Controlled Trials, ID: ISRCTN86725795. Registered on 31 May 2016.  
Appendix
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Metadata
Title
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
Authors
Elizabeth Edginton
Rebecca Walwyn
Kayleigh Burton
Robert Cicero
Liz Graham
Sadie Reed
Sandy Tubeuf
Maureen Twiddy
Alex Wright-Hughes
Lynda Ellis
Dot Evans
Tom Hughes
Nick Midgley
Paul Wallis
David Cottrell
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2166-2

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