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;Cottrell, David;et.al.
(2017) Trials — Vol. 18, n° 1, p. 16p (2017)

Files

TIGA.pdf
  • Open Access
  • Adobe PDF
  • 1.4 MB
Download

Details

Authors
  • Edginton, Elizabethorcid-logo
    Author
  • Walwyn, Rebecca
    Author
  • Burton, Kayleigh
    Author
  • Cicero, Robert
    Author
  • Tubeuf, Sandyorcid-logoUCLouvain
    Author
  • Cottrell, David
    Author
Show more
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.
Affiliations
  • Leeds Clinical Trials Research UnitUniversity of Leeds

Citations

  • APA
  • Chicago
  • FWB

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), 16p. https://doi.org/10.1186/s13063-017-2166-2 (Original work published 2017)