Title: Feasibility Study for a Trial on Improving Inter-generational Attachment for Children Undergoing Behaviour Problems (TIGA-CUB)
Funder: Department of Health and Social Care

Abstract: NICE recommends group or individual parent training programmes as first-line treatments for conduct disorders. These are effective for 66-75% of children, but little is known about what to do if they fail. NICE recommends research on second-line treatments [1,13,35]. Existing research suggests child psychotherapy, including parent work, might help - but the evidence base is limited [36]. We propose a feasibility study for a pragmatic, large-scale, multi-centre RCT to determine clinical and cost-effectiveness of manualised child psychotherapy versus TaU, the outcomes of which would be: Primary: reduction in child s disordered behaviour, measured with Child Behavior Checklist (primary carer). Secondary: remission of conduct disorder; child and primary carer mental health; parental reflective functioning; quality of life, resource use, lost productivity; child s school conduct, attendance, and performance; treatment attendance. These may also be mediators of impact of the intervention on the primary outcome. The objectives of the feasibility study are to: establish procedures for screening; assess acceptability of randomisation; estimate baseline, 4, and 8 month follow-up rates and data quality; assess feasibility of collecting data and maintaining research assistant blinding; identify best ways to assess quality of life and cost-effectiveness; establish procedures for assessing manual adherence; confirm variability and clustering of outcomes by clinician to inform sample size calculations. Study design: Two-arm, pragmatic, parallel-group, multi-centre, individually-randomised controlled feasibility study. Setting: 5 CAMHS in Bradford, Leeds, Manchester, Sheffield, and Wakefield. Target population: (i) children aged 5-11 (ii) presenting to CAMHS with a clinical conduct disorder (&ge;4 on Strengths and Difficulties Questionnaire (SDQ) [37] conduct sub-scale) (iii) and their primary carers (iv) previously unsuccessful parenting programme, defined as: first-line group or individual parenting programme attended for at least one session, conduct disorder persists, re-referred for further treatment. Initial Screening: Child referred with conduct disorder, screened against eligibility criteria, primary carer informed about study, consent obtained for researcher contact. Further Screening and Recruitment: Researcher visits, explains study, obtains consent from, and screens primary carer using Alcohol-Use Disorders Identification Test [38], Drug Abuse Screening Test [39], description of previous conduct treatment(s); eligibility confirmed. Baseline Data Collection: Primary carer completes: Child Behavior Checklist (CBCL) [40], General Health Questionnaire 12 [41], Parenting Stress Index [42], Beck Depression Inventory [43], Parental Reflective Functioning Questionnaire [44], EQ-5D; child completes EQ-5D-Y [45-48].Consent to contact teacher, who completes CBCL [49]. Randomisation: Child and primary carer dyads randomised 1:1 (stratified by CAMHS and gender) to (i) child psychotherapy or (ii) TaU. For child psychotherapy arm, randomisation to Child Psychotherapists within CAMHS to avoid confounding. Intervention: Manualised child psychotherapy provided by 10-15 qualified Child Psychotherapists or senior trainees: child and primary carer(s) each receive 12 x 50 minute, concurrent weekly sessions. Controls: TaU. Children and/or primary carer(s) receive one of a range of interventions, determined by CAMHS normal clinical practice. Follow-up: 4 months post-randomisation, researcher visits primary carer: primary carer completes SDQ, baseline measures, and resource usage questionnaire; child completes EQ-5D-Y; teacher completes CBCL; at 8 months, SDQ and above measures completed by primary carer; child completes EQ-5D-Y; teacher completes CBCL. Feasibility Outcomes: Screening, recruitment, follow-up rates, acceptability of questionnaires, data quality (including missing data), outcome variability and clustering, quality of life and resource use data, treatment adherence, previous conduct interventions, TaU characteristics. Sample size: 60 child-primary carer dyads (30 per arm) provide sufficient data to establish recruitment and retention strategies, estimate adherence, and inform sample size for definitive trial. Analysis: Qualitative and quantitative, primarily descriptive rather than formal hypothesis testing, including resource use data and process evaluation. Benefits: Determination of feasibility of definitive RCT, with potential to determine effectiveness of child psychotherapy as a second-line treatment for resistant conduct disorder.

Lay abstract: Five percent of 5-10 year olds have persistent, repetitive, aggressive, antisocial, or defiant age- inappropriate behaviours ( conduct disorders ). These can result in long-term, negative outcomes including unemployment, mental and physical health difficulties, addictions, and crime. Children with conduct disorders cost public services ten times more than children without. Whilst 66-75% of families benefit from first line parenting programmes, a substantial minority require further treatment. Our study will recruit children and primary carers (adults most involved in parenting) for whom parenting programmes have not been successful. We will randomly allocate them to an intervention comprising 12 sessions of child psychotherapy and 12 sessions of parent work, or to usual treatment. Primary carers and children will complete assessments at the beginning, middle, and end of study participation. Our research will show whether we can successfully recruit, deliver treatment, and collect data. If we can, we plan to run a large-scale, multi-centre trial to find out whether child psychotherapy is effective and cost-effective in treating children s conduct disorders in the NHS. Our intervention is based on a form of treatment already available in the NHS which we have shortened and written down in a handbook for child psychotherapists delivering the intervention. Clinical experience and research suggest that this might be suitable for children with hard to treat conduct disorders. These children often feel insecure and have problems relating to others ( attachment difficulties ), while their primary carers are more likely to have similar problems from when they were children ( inter-generational attachment difficulties ). These difficulties have been linked to problems in understanding connections between behaviour, thoughts, and feelings, and to adult mental health difficulties. Small research studies on this kind of treatment including children with conduct disorders have already been undertaken, but a large trial is needed. Our study is the first step towards this.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH