Autism spectrum disorder affects more than 5 million children in south Asia. Although early interventions have been used for the treatment of children in high-income countries, no substantive trials ...have been done of the interventions adapted for use in low-income and middle-income countries (LMICs). We therefore assessed the feasibility and acceptability of the parent-mediated intervention for autism spectrum disorder in south Asia (PASS) in India and Pakistan.
A single-blind randomised trial of the comparison of 12 sessions of PASS (plus treatment as usual) with treatment as usual alone delivered by non-specialist health workers was done at two centres in Goa, India, and Rawalpindi, Pakistan. Children aged 2-9 years with autism spectrum disorder were randomly assigned (1:1) by use of probabilistic minimisation, controlling for treatment centre (Goa or Rawalpindi), age (<6 years or ≥6 years), and functional impairment (Vineland Adaptive Behaviour Scale Composite score <65 or ≥65). The primary outcome was quality of parent-child interaction on the Dyadic Communication Measure for Autism at 8 months. Analysis was by intention to treat. The study is registered with ISRCTN, number ISRCTN79675498.
From Jan 1 to July 30, 2013, 65 children were randomly allocated, 32 to the PASS group (15 in Goa and 17 in Rawalpindi) and 33 to the treatment-as-usual group (15 in Goa and 18 in Rawalpindi). 26 (81%) of 32 participants completed the intervention. After adjustment for minimisation factors and baseline outcome, the primary outcome showed a treatment effect in favour of PASS in parental synchrony (adjusted mean difference 0·25 95% CI 0·14 to 0·36; effect size 1·61 95% CI 0·90 to 2·32) and initiation of communication by the child with the parent (0·15 0·04 to 0·26; effect size 0·99 0·29 to 1·68), but time in mutual shared attention was reduced (-0·16 -0·26 to -0·05; effect size -0·70 -1·16 to -0·23).
Our results show the feasibility of adapting and task-shifting an intervention used in a high-income context to LMICs. The findings also replicate the positive primary outcome treatment effects of a parent-mediated communication-focused intervention in the original UK Preschool Autism Communication Trial, with one negative effect not reported previously.
Autism Speaks, USA.
Observational studies are suited to examining links between the routine hospital management of self-harm and future suicide and all-cause mortality due to their large scale. However, care must be ...taken when attempting to infer causal associations in non-experimental settings.
Data from the Multicentre Study of Self-Harm in England were used to examine associations between four types of hospital management (specialist psychosocial assessment, general hospital admission, psychiatric outpatient referral and psychiatric admission) following self-harm and risks of suicide and all-cause mortality in the subsequent 12 months. Missing data were handled by multiple imputation and propensity score (PS) methods were used to address observed differences between patients at baseline. Unadjusted, PS stratified and PS matched risk ratios (RRs) were calculated.
The PSs balanced the majority of baseline differences between treatment groups. Unadjusted RRs showed that all four treatment types were associated with either increased risks or no change in risks of suicide and all-cause mortality within a year. None of the four types of hospital management were associated with lowered risks of suicide or all-cause mortality following propensity score stratification (psychosocial assessment and medical admission) and propensity score matching (psychiatric outpatient referral and psychiatric admission), though there was no longer an increased risk among people admitted to a psychiatric bed. Individuals who self-cut were at an increased risk of death from any cause following psychosocial assessment and medical admission. Medical admission appeared to be associated with reduced risk of suicide in individuals already receiving outpatient or GP treatment for a psychiatric disorder.
More intensive forms of hospital management following self-harm appeared to be appropriately allocated to individuals with highest risks of suicide and all-cause mortality. PS adjustment appeared to attenuate only some of the observed increased risks, suggesting that either differences between treatment groups remained, or that some treatments had little impact on reducing subsequent suicide or all-cause mortality risk. These findings are in contrast to some previous studies that have suggested psychosocial assessment by a mental health specialist reduces risk of repeat self-harm. Future observational self-harm studies should consider increasing the number of potential confounding variables collected.
In mental health practice, both pharmacological and non-pharmacological treatments are aimed at improving neuropsychological symptoms, including cognitive and emotional impairments. However, at ...present there is no established neuropsychological test battery that comprehensively covers multiple affective domains relevant in a range of disorders. Our objective was to generate a standardized test battery, comprised of existing, adapted and novel tasks, to assess four core domains of affective cognition (emotion processing, motivation, impulsivity and social cognition) in order to facilitate and enhance treatment development and evaluation in a broad range of neuropsychiatric disorders. The battery was administered to 200 participants aged 18-50 years (50% female), 42 of whom were retested in order to assess reliability. An exploratory factor analysis identified 11 factors with eigenvalues greater than 1, which accounted for over 70% of the variance. Tasks showed moderate to excellent test-retest reliability and were not strongly correlated with demographic factors such as age or IQ. The EMOTICOM test battery is therefore a promising tool for the assessment of affective cognitive function in a range of contexts.
Suicidal thoughts, acts, plans and deaths are considerably more prevalent in people with non-affective psychosis, including schizophrenia, compared to the general population. Social isolation and ...interpersonal difficulties have been implicated in pathways which underpin suicidal experiences in people with severe mental health problems. However, the interactions between psychotic experiences, such as hallucinations and paranoia, suicidal experiences, and the presence, and indeed, absence of interpersonal relationships is poorly understood and insufficiently explored. The current study sought to contribute to this understanding.
An inductive thematic analysis was conducted on transcripts of 22, individual, semi-structured interviews with adult participants who had both non-affective psychosis and recent suicidal experiences. A purposive sampling strategy was used. Trustworthiness of the analysis was assured with researcher triangulation.
Participants relayed both positive and negative experiences of interpersonal relationships. A novel conceptual model is presented reflecting a highly complex interplay between a range of different suicidal experiences, psychosis, and aspects of interpersonal relationships. Three themes fed into this interplay, depicting dynamics between perceptions of i. not mattering and mattering, ii. becoming disconnected from other people, and iii. constraints versus freedom associated with sharing suicidal and psychotic experiences with others.
This study revealed a detailed insight into ways in which interpersonal relationships are perceived to interact with psychotic and suicidal experiences in ways that can be both beneficial and challenging. This is important from scientific and clinical perspectives for understanding the complex pathways involved in suicidal experiences.
ClinicalTrials.gov (NCT03114917), 14
April 2017. ISRCTN (reference ISRCTN17776666 .); 5
June 2017). Registration was recorded prior to participant recruitment commencing.
There is good evidence that psychological interventions improve patient well-being and independent living, but patients on acute mental health wards often do not have access to evidence-based ...psychological therapies which are strongly advised by NICE guidance for severe mental health problems. The overall aim of this programme of work is to increase patient access to psychological therapies on acute mental health inpatient wards. Stage one of the programme (which is complete) aimed to identify barriers and facilitators to delivering therapy in these settings through a large qualitative study. The key output of stage one was an intervention protocol that is designed to be delivered on acute wards to increase patient access to psychologically-informed care and therapy. Stage two of the programme aims to test the effects of the intervention on patient wellbeing and serious incidents on the ward (primary outcomes), patient social functioning and symptoms, staff burnout, ward atmosphere from staff and patient perspectives and cost effectiveness of the intervention (secondary outcomes).
The study is a single blind, pragmatic, cluster randomised controlled trial and will recruit thirty-four wards across England that will be randomised to receive the new intervention plus treatment as usual, or treatment as usual only. Primary and secondary outcomes will be assessed at baseline and 6-month and 9-month follow-ups, with serious incidents on the ward collected at an additional 3-month follow-up.
The key output will be a potentially effective and cost-effective ward-based psychological intervention that increases patient access to psychological therapy in inpatient settings, is feasible to deliver in inpatient settings and is acceptable to patients.
ClinicalTrials.gov Identifier: NCT03950388. Registered 15
May 2019. https://clinicaltrials.gov/ct2/show/NCT03950388.
Prior evidence shows that behaviours closely related to the intervention delivered for autism are amenable to change, but it is more difficult to generalise treatment effects beyond the intervention ...context. We test an early autism intervention designed to promote generalisation of therapy-acquired skills into home and school contexts to improve adaptive function and reduce symptoms. A detailed mechanism study will address the process of such generalisation. Objective 1 will be to test if the PACT-G intervention improves autism symptom outcome in the home and school context of the intervention as well as in the primary outcome research setting. Objective 2 will use the mechanism analysis to test for evidence of acquired skills from intervention generalizing across contexts and producing additive effects on primary outcome.
This is a three-site, two-parallel-group, randomised controlled trial of the experimental treatment plus treatment as usual (TAU) versus TAU alone. Children aged 2-11 years (n = 244 (122 intervention/122 TAU; ~ 82/site) meeting criteria for core autism will be eligible. The experimental intervention builds on a clinic-based Pre-school Autism Communication Treatment model (PACT), delivered with the primary caregiver, combined with additional theory- and evidence-based strategies designed to enhance the generalisation of effects into naturalistic home and education contexts. The control intervention will be TAU.
autism symptom outcome, researcher-assessed using a standardised protocol.
autism symptoms, child interaction with parent or teacher, language and reported functional outcomes in home and school settings. Outcomes measured at baseline and 12-month endpoint in all settings with interim interaction measurements (7 months) to test treatment effect mechanisms. Primary analysis will estimate between-group difference in primary outcome using analysis of covariance with test of homogeneity of effect across age group. Mechanism analysis will use regression models to test for mediation on primary outcome by parent-child and teaching staff-child social interaction.
This is an efficacy and mechanism trial of generalising evidence-based autism treatment into home and school settings. It will provide data on whether extending treatment across naturalistic contexts enhances overall effect and data on the mechanism in autism development of the generalisation of acquired developmental skills across contexts.
ISRCTN, ID: 25378536 . Prospectively registered on 9 March 2016.
Randomised controlled trials ('trials') are susceptible to poor participant recruitment and retention. Studies Within A Trial are the strongest methods for testing the effectiveness of strategies to ...improve recruitment and retention. However, relatively few of these have been conducted.
PROMoting THE Use of Studies Within A Trial aimed to facilitate at least 25 Studies Within A Trial evaluating recruitment or retention strategies. We share our experience of delivering the PROMoting THE Use of Studies Within A Trial programme, and the lessons learnt for undertaking randomised Studies Within A Trial.
A network of 10 Clinical Trials Units and 1 primary care research centre committed to conducting randomised controlled Studies Within A Trial of recruitment and/or retention strategies was established. Promising recruitment and retention strategies were identified from various sources including Cochrane systematic reviews, the Study Within A Trial Repository, and existing prioritisation exercises, which were reviewed by patient and public members to create an initial priority list of seven recruitment and eight retention interventions. Host trial teams could apply for funding and receive support from the PROMoting THE Use of Studies Within A Trial team to undertake Studies Within A Trial. We also tested the feasibility of undertaking co-ordinated Studies Within A Trial, across multiple host trials simultaneously.
Clinical trials unit-based trials recruiting or following up participants in any setting in the United Kingdom were eligible.
Clinical trials unit-based teams undertaking trials in any clinical context in the United Kingdom.
Funding of up to £5000 and support from the PROMoting THE Use of Studies Within A Trial team to design, implement and report Studies Within A Trial.
Number of host trials funded.
Forty-two Studies Within A Trial were funded (31 host trials), across 12 Clinical Trials Units. The mean cost of a Study Within A Trial was £3535. Twelve Studies Within A Trial tested the same strategy across multiple host trials using a co-ordinated Study Within A Trial design, and four used a factorial design. Two recruitment and five retention strategies were evaluated in more than one host trial. PROMoting THE Use of Studies Within A Trial will add 18% more Studies Within A Trial to the Cochrane systematic review of recruitment strategies, and 79% more Studies Within A Trial to the Cochrane review of retention strategies. For retention, we found that pre-notifying participants by card, letter or e-mail before sending questionnaires was effective, as was the use of pens, and sending personalised text messages to improve questionnaire response. We highlight key lessons learnt to guide others planning Studies Within A Trial, including involving patient and public involvement partners; prioritising and selecting strategies to evaluate and elements to consider when designing a Study Within A Trial; obtaining governance approvals; implementing Studies Within A Trial, including individual and co-ordinated Studies Within A Trials; and reporting Study Within A Trials.
The COVID-19 pandemic negatively impacted five Studies Within A Trial, being either delayed (
= 2) or prematurely terminated (
= 3).
PROMoting THE Use of Studies Within A Trial significantly increased the evidence base for recruitment and retention strategies. When provided with both funding and practical support, host trial teams successfully implemented Studies Within A Trial.
Future research should identify and target gaps in the evidence base, including widening Study Within A Trial uptake, undertaking more complex Studies Within A Trial and translating Study Within A Trial evidence into practice.
All Studies Within A Trial in the PROMoting THE Use of Studies Within A Trial programme had to be registered with the Northern Ireland Network for Trials Methodology Research Study Within A Trial Repository.
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 13/55/80) and is published in full in
; Vol. 28, No. 2. See the NIHR Funding and Awards website for further award information.
Suicide is a leading cause of death globally. Suicide deaths are elevated in those experiencing severe mental health problems, including schizophrenia. Psychological talking therapies are a ...potentially effective means of alleviating suicidal thoughts, plans, and attempts. However, talking therapies need to i) focus on suicidal experiences directly and explicitly, and ii) be based on testable psychological mechanisms. The Cognitive AppRoaches to coMbatting Suicidality (CARMS) project is a Randomised Controlled Trial (RCT) which aims to investigate both the efficacy and the underlying mechanisms of a psychological talking therapy for people who have been recently suicidal and have non-affective psychosis.
The CARMS trial is a two-armed single-blind RCT comparing a psychological talking therapy (Cognitive Behavioural Suicide Prevention for psychosis CBSPp) plus Treatment As Usual (TAU) with TAU alone. There are primary and secondary suicidality outcome variables, plus mechanistic, clinical, and health economic outcomes measured over time. The primary outcome is a measure of suicidal ideation at 6 months after baseline. The target sample size is 250, with approximately 125 randomised to each arm of the trial, and an assumption of up to 25% attrition. Hence, the overall recruitment target is up to 333. An intention to treat analysis will be used with primary stratification based on National Health Service (NHS) recruitment site and antidepressant prescription medication. Recruitment will be from NHS mental health services in the North West of England, UK. Participants must be 18 or over; be under the care of mental health services; have mental health problems which meet ICD-10 non-affective psychosis criteria; and have experienced self-reported suicidal thoughts, plans, and/or attempts in the 3 months prior to recruitment. Nested qualitative work will investigate the pathways to suicidality, experiences of the therapy, and identify potential implementation challenges beyond a trial setting as perceived by numerous stake-holders.
This trial has important implications for countering suicidal experiences for people with psychosis. It will provide definitive evidence about the efficacy of the CBSPp therapy; the psychological mechanisms which lead to suicidal experiences; and provide an understanding of what is required to implement the intervention into services should it be efficacious.
ClinicalTrials.gov (NCT03114917), 14th April 2017. ISRCTN (reference ISRCTN17776666 https://doi.org/10.1186/ISRCTN17776666); 5th June 2017). Registration was recorded prior to participant recruitment commencing.
Older people are the fastest-growing demographic group among prisoners in England and Wales and they have complex health and social care needs. Their care is frequently ad hoc and uncoordinated. No ...previous research has explored how to identify and appropriately address the needs of older adults in prison. We hypothesised that the Older prisoner Health and Social Care Assessment and Plan (OHSCAP) would significantly increase the proportion of met health and social care needs 3 months after prison entry, compared to treatment as usual (TAU).
The study was a parallel randomised controlled trial (RCT) recruiting male prisoners aged 50 and over from 10 prisons in northern England. Participants received the OHSCAP or TAU. A clinical trials unit used minimisation with a random element as the allocation procedure. Data analysis was conducted blind to allocation status. The intervention group had their needs assessed using the OHSCAP tool and care plans were devised; processes that lasted approximately 30 min in total per prisoner. TAU included the standard prison health assessment and care. The intention to treat principle was followed. The trial was registered with the UK Clinical Research Network Portfolio (ISRCTN ID: 11841493) and was closed on 30 November 2016.
Data were collected between 28 January 2014 and 06 April 2016. Two hundred and forty nine older prisoners were assigned TAU of which 32 transferred prison; 12 were released; 2 withdrew and 1 was deemed unsafe to interview. Two hundred and fifty three 3 prisoners were assigned the OHSCAP of which 33 transferred prison; 11 were released; 6 withdrew and 1 was deemed unsafe to interview. Consequently, data from 202 participants were analysed in each of the two groups. There were no significant differences in the number of unmet needs as measured by the Camberwell Assessment of Needs - Forensic Short Version (CANFOR-S). The mean number of unmet needs for the OHSCAP group at follow-up was 2.03 (SD = 2.07) and 2.06 (SD = 2.11) for the TAU group (mean difference = 0.088; 95% CI - 0.276 to 0.449, p = 0.621). No adverse events were reported.
The OHSCAP was fundamentally not implemented as planned, partly due to the national prison staffing crisis that ensued during the study period. Therefore, those receiving the OHSCAP did not experience improved outcomes compared to those who received TAU.
Current Controlled Trials: ISRCTN11841493 , 25/10/2012.
AVATAR therapy is a novel intervention targeting distressing auditory verbal hallucinations (henceforth 'voices'). A digital simulation (avatar) of the voice is created and used in a three-way ...dialogue between participant, avatar and therapist. To date, therapy has been delivered over 6 sessions, comprising an initial phase, focusing on standing up to a hostile avatar, and a second phase in which the avatar concedes and focus shifts to individualised treatment targets, including beliefs about voices. The first fully powered randomised trial found AVATAR therapy resulted in a rapid and substantial fall in voice frequency and associated distress that was superior to supportive counselling at 12 weeks. The main objective of this AVATAR2 trial is to test the efficacy of two forms of AVATAR therapy in reducing voice-related distress: AVATAR-brief (standardised focus on exposure, assertiveness and self-esteem) and AVATAR-extended (phase 1 mirroring AVATAR-brief augmented by a formulation-driven phase 2). Secondary objectives include the examination of additional voice, wellbeing and mood outcomes, the exploration of mediators and moderators of therapy response, and examining cost-effectiveness of both forms of therapy compared with usual treatment (TAU).
This multi-site parallel group randomised controlled trial will independently randomise 345 individuals to receive AVATAR-brief (6 sessions) plus TAU or AVATAR-extended (12 sessions) plus TAU or TAU alone (1:1:1 allocation). Participants will be people with a diagnosis of schizophrenia spectrum and other psychotic disorders who have heard distressing voices for more than 6 months. The primary outcome is the PSYRATS Auditory Hallucinations Distress dimension score at 16 and 28 weeks, conducted by blinded assessors. Statistical analysis will follow the intention-to-treat principle and data will be analysed using linear mixed models. Mediation and moderation analyses using contemporary causal inference methods will be conducted as secondary analyses. Service costs will be calculated, and cost-effectiveness assessed in terms of quality-adjusted life years accrued.
This study will clarify optimal therapy delivery, test efficacy in a multi-site study and enable the testing of the AVATAR software platform, therapy training and provision in NHS settings.
ISRCTN registry ISRCTN55682735 . Registered on 22 January 2020. The trial is funded by the Wellcome Trust (WT).
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