Self-harm in adolescents is common and repetition occurs in a high proportion of these cases. Scarce evidence exists for effectiveness of interventions to reduce self-harm. This pragmatic, multicentre, randomised, controlled trial of family therapy versus treatment as usual was done at 40 UK Child and Adolescent Mental Health Services (CAMHS) centres. We recruited young people aged 11-17 years who had self-harmed at least twice and presented to CAMHS after self-harm. Participants were randomly assigned (1:1) to receive manualised family therapy delivered by trained and supervised family therapists or treatment as usual by local CAMHS. Participants and therapists were aware of treatment allocation; researchers were masked. The primary outcome was hospital attendance for repetition of self-harm in the 18 months after group assignment. Primary and safety analyses were done in the intention-to-treat population. The trial is registered at the ISRCTN registry, number ISRCTN59793150. Between Nov 23, 2009, and Dec 31, 2013, 3554 young people were screened and 832 eligible young people consented to participation and were randomly assigned to receive family therapy (n=415) or treatment as usual (n=417). Primary outcome data were available for 795 (96%) participants. Numbers of hospital attendances for repeat self-harm events were not significantly different between the groups (118 [28%] in the family therapy group vs 103 [25%] in the treatment as usual group; hazard ratio 1·14 [95% CI 0·87-1·49] p=0·33). Similar numbers of adverse events occurred in both groups (787 in the family therapy group vs 847 in the treatment as usual group). For adolescents referred to CAMHS after self-harm, having self-harmed at least once before, our family therapy intervention conferred no benefits over treatment as usual in reducing subsequent hospital attendance for self-harm. Clinicians are therefore still unable to recommend a clear, evidence-based intervention to reduce repeated self-harm in adolescents. National Institute for Health Research Health Technology Assessment programme.

Dopamine is a key modulator of striatal function and learning and might improve motor recovery after stroke. Previous small trials of dopamine agonists after stroke provide equivocal evidence of effectiveness on improving motor recovery. We aimed to assess the safety and efficacy of co-careldopa plus routine occupational and physical therapy during early rehabilitation after stroke. This double-blind, multicentre, randomised controlled trial of co-careldopa versus placebo in addition to routine NHS occupational and physical therapy was done at 51 UK NHS acute inpatient stroke rehabilitation services. We recruited patients with new or recurrent clinically diagnosed ischaemic or haemorrhagic (excluding subarachnoid haemorrhage) stroke 5-42 days before randomisation, who were unable to walk 10 m or more, had a score of less than 7 points on the Rivermead Mobility Index, were expected to need rehabilitation, and were able to access rehabilitation after discharge from hospital. Participants were assigned (1:1) using stratified random blocks to receive 6 weeks of oral co-careldopa or matched placebo in addition to routine NHS physiotherapy and occupational therapy. The initial two doses of co-careldopa were 62·5 mg (50 mg of levodopa and 12·5 mg of carbidopa) and the remaining doses were 125 mg (100 mg of levodopa and 25 mg of carbidopa). Participants were required to take a single oral tablet 45-60 min before physiotherapy or occupational therapy session. The primary outcome was ability to walk independently, defined as a Rivermead Mobility Index score of 7 or more, at 8 weeks. Primary and safety analyses were done in the intention-to-treat population. The trial is registered on the ISRCTN registry, number ISRCTN99643613. Between May 30, 2011, and March 28, 2014, of 1574 patients found eligible, 593 (mean age 68·5 years) were randomly assigned to either the co-careldopa group (n=308) or to the placebo group (n=285), on an average 18 days after stroke onset. Primary outcome data were available for all 593 patients. We found no evidence that the ability to walk independently improved with co-careldopa (125 [41%] of 308 patients) compared with placebo (127 [45%] of 285 patients; odds ratio 0·78 [95% CI 0·53-1·15]) at 8 weeks. Mortality at 12 months did not differ between the two groups (22 [7%] vs 17 [6%]). Serious adverse events were largely similar between groups. Vomiting during therapy sessions, after taking the study drug, was the most frequent adverse event and was more frequent in the co-careldopa group than the placebo group (19 [6·2%] vs 9 [3·2%]). Co-careldopa in addition to routine occupational and physical therapy does not seem to improve walking after stroke. Further research might identify subgroups of patients with stroke who could benefit from dopaminergic therapy at different doses or times after stroke with more intensive motor therapy. Medical Research Council.

Purpose Traditionally, researchers have relied on eliciting preferences through face-to-face interviews. Recently, there has been a shift towards using internet-based methods. Different methods of data collection may be a source of variation in the results. In this study, we compare the preferences for the Adult Social Care Outcomes Toolkit (ASCOT) service user measure elicited using best–worst scaling (BWS) via a face-to-face interview and an online survey. Methods Data were collected from a representative sample of the general population in England. The respondents (face-to-face: n = 500; online: n = 1001) completed a survey, which included the BWS experiment involving the ASCOT measure. Each respondent received eight best–worst scenarios and made four choices (best, second best, worst, second worst) in each scenario. Multinomial logit regressions were undertaken to analyse the data taking into account differences in the characteristics of the two samples and the repeated nature of the data. Results We initially found a number of small significant differences in preferences between the two methods across all ASCOT domains. These differences were substantially reduced—from 15 to 5 out of 30 coefficients being different at the 5% level—and remained small in value after controlling for differences in observable and unobservable characteristics of the two samples. Conclusions This comparison demonstrates that face-to-face and internet surveys may lead to fairly similar preferences for social care-related quality of life when differences in sample characteristics are controlled for. With or without a constant sampling frame, studies should carefully design the BWS exercise and provide similar levels of clarification to participants in each survey to minimise the amount of error variance in the choice process.

There is increasing interest in assessing the effects of interventions on older people, people with long-term conditions and their informal carers for use in economic evaluation. The Adult Social Care Outcomes Toolkit for Carers (ASCOT-Carer) is a measure that specifically assesses the impact of social care services on informal carers. To date, the ASCOT-Carer has not been preference-weighted. To estimate preference-based index values for the English version of the ASCOT-Carer from the general population in England. The ASCOT-Carer consists of 7 domains, each reflecting aspects of social care-related quality of life in informal carers. Preferences for the ASCOT-Carer social care-related quality of life states were estimated using a best-worst scaling exercise in an online survey. The survey was administered to a sample of the general adult population in England (n = 1000). Participants were asked to put themselves into the hypothetical state of being an informal carer and indicate which attribute they thought was the best (first and second) and worst (first and second) from a profile list of 7 attributes reflecting the 7 domains, each ranging at a different level (1-4). Multinomial logit regression was used to analyze the data and estimate preference weights for the ASCOT-Carer measure. The most valued aspect by English participants was the 'occupation' attribute at its highest level. Results further showed participants rated having no control over their daily life as the lowest attribute-level of all those presented. The position of the 7 attributes influenced participants' best and worst choices, and there was evidence of both scale and taste heterogeneity on preferences. This study has established a set of preference-based index values for the ASCOT-Carer in England derived from the best-worst scaling exercise that can be used for economic evaluation of interventions on older individuals and their informal carers.

This article presents alternative parental health spillover quantification methods in the context of a randomised controlled trial comparing family therapy with treatment as usual as an intervention for self-harming adolescents, and discusses the practical limitations of those methods.

Background: Self-harm in adolescents is common and repetition rates high. There is limited evidence of the effectiveness of interventions to reduce self-harm.Objectives: To assess the clinical effectiveness and cost-effectiveness of family therapy (FT) compared with treatment as usual (TAU).Design: A pragmatic, multicentre, individually randomised controlled trial of FT compared with TAU. Participants and therapists were aware of treatment allocation; researchers were blind to allocation.Setting: Child and Adolescent Mental Health Services (CAMHS) across three English regions.Participants: Young people aged 11–17 years who had self-harmed at least twice presenting to CAMHS following self-harm.Interventions: Eight hundred and thirty-two participants were randomised to manualised FT delivered by trained and supervised family therapists (n = 415) or to usual care offered by local CAMHS following self-harm (n = 417).Main outcome measures: Rates of repetition of self-harm leading to hospital attendance 18 months after randomisation.Results: Out of 832 young people, 212 (26.6%) experienced a primary outcome event: 118 out of 415 (28.4%) randomised to FT and 103 out of 417 (24.7%) randomised to TAU. There was no evidence of a statistically significant difference in repetition rates between groups (the hazard ratio for FT compared with TAU was 1.14, 95% confidence interval 0.87 to 1.49;p = 0.3349). FT was not found to be cost-effective when compared with TAU in the base case and most sensitivity analyses. FT was dominated (less effective and more expensive) in the complete case. However, when young people’s and caregivers’ quality-adjusted life-year gains were combined, FT incurred higher costs and resulted in better health outcomes than TAU within the National Institute for Health and Care Excellence cost-effectiveness range. Significant interactions with treatment, indicating moderation, were detected for the unemotional subscale on the young person-reported Inventory of Callous–Unemotional Traits (p = 0.0104) and the affective involvement subscale on the caregiver-reported McMaster Family Assessment Device (p = 0.0338). Caregivers and young people in the FT arm reported a range of significantly better outcomes on the Strengths and Difficulties Questionnaire. Self-reported suicidal ideation was significantly lower in the FT arm at 12 months but the same in both groups at 18 months. No significant unexpected adverse events or side effects were reported, with similar rates of expected adverse events across trial arms.Conclusions: For adolescents referred to CAMHS after self-harm, who have self-harmed at least once before, FT confers no benefits over TAU in reducing self-harm repetition rates. There is some evidence to support the effectiveness of FT in reducing self-harm when caregivers reported poor family functioning. When the young person themselves reported difficulty expressing emotion, FT did not seem as effective as TAU. There was no evidence that FT is cost-effective when only the health benefits to participants were considered but there was a suggestion that FT may be cost-effective if health benefits to caregivers are taken into account. FT had a significant, positive impact on general emotional and behavioural problems at 12 and 18 months.Limitations: There was significant loss to follow-up for secondary outcomes and health economic analyses; the primary outcome misses those who do not attend hospital following self-harm; and the numbers receiving formal FT in the TAU arm were higher than expected.Future work: Evaluation of interventions targeted at subgroups of those who self-harm, longer-term follow-up and methods for evaluating health benefits for family groups rather than for individuals.Trial registration: Current Controlled Trials ISRCTN59793150.Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 12. See the NIHR Journals Library website for further project information.