Abstract
BackgroundThe 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 designTIGA-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.DiscussionTIGA-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 registrationCurrent Controlled Trials, ID: ISRCTN86725795. Registered on 31 May 2016.
Highlights
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
This paper describes the protocol for the feasibility trial evaluating manualised Psychoanalytic Child Psychotherapy compared with Treatment as Usual (TaU) within Child and Adolescent Mental Health Services (CAMHS)
If revisions are needed but are possible, the suggested revisions will be described in detail in the feasibility trial outputs
Summary
Design TIGA-CUB is a multicentre, two-arm, pragmatic, parallelgroup, individually randomised controlled feasibility trial. Therapeutic delivery: (1) proportion of dyads randomised to the intervention arm, proportion randomised to, and seen by, the allocated CAPT; proportion of dyads successfully completing the required number of mPCP sessions specified in the manual; number of those dyads where there was a mutually agreed earlier termination, including reasons for early termination; early (nonagreed) dropouts from the intervention, including reasons for early dropout; (2) methods developed for measuring dyad treatment attendance and CAPT adherence to the manual, including the number of mPCP sessions offered, attended, and missed, and evidence of the appropriate use of the clinical approach advocated in the intervention manual; (3) preliminary assessment of the acceptability of the intervention, including negative outcomes, serious adverse events (SAEs), and related and unexpected SAEs (RUSAEs) (all RUSAEs occurring from the date of consent up to 4 (8, where applicable) months post randomisation will be recorded, reviewed by the chief investigator, and reported to the Research Ethics Committee (REC) and the sponsor within 15 days; (4) mapping of the range of standard care (CAMHS/external) pathways across arms; and (5) number of patients where the standard care pathway is known. Members of the LAG will advise on promoting the trial and disseminating results, and will be involved in the interpretation of the qualitative results
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