A randomised controlled trial of clinical and cost-effectiveness of the PASS Plus intervention for young children with autism spectrum disorder in New Delhi, India: Study protocol for the COMPASS trial. (preprint)

Background: Autism Spectrum Disorders (ASD) is a neurodevelopmental disability affecting at least 5 million children in South Asia. Majority of these children are without access to evidence-based care. The UK Pre-school Autism Communication Therapy (PACT) is the only intervention to have shown sustained impact on autism symptoms. It was systematically adapted for non-specialist community delivery in South Asia; as the 'Parent-mediated Autism Social Communication Intervention for non-Specialists (PASS) and extended ‘PASS Plus’ interventions. RCTs of both showed feasibility, acceptability and positive effect on parent and child dyadic outcomes. Methods: The Communication-centred Parent-mediated treatment for Autism Spectrum Disorder in South Asia (COMPASS) trial is now a scale-up two centre, two arm single (rater) blinded random allocation parallel group study of the PASS Plus intervention in addition to treatment as usual (TAU) compared to TAU alone, plus health economic evaluation – embedded in the India health system. 240 children (approximately 120 intervention/120 TAU) with ASD aged 2-9 years will be recruited from two tertiary care government hospitals in New Delhi, India. Accredited Social Health Activists will be one of the intervention delivery agents. Families will undertake up to 12 communication sessions over 8 months and will be offered the Plus modules which address coexisting problems. The trial’s primary endpoint is at 9 months from randomization, with follow-up at 15 months. The primary outcome is autism symptom severity; secondary outcomes include parent-child communication, child adaptation, quality of life and parental wellbeing. Primary analysis will follow intention-to-treat principles using linear mixed model regressions with group allocation and repeated measures as random effects. The primary cost-effectiveness analysis will use a societal perspective over the 15-month period of intervention and follow-up. Discussion: If clinically and cost effective, this programme will fill an important gap of scalable interventions delivered by non specialist health workers within the current care pathways for autistic children and their families in low resource contexts. The programme has been implemented through the COVID-19 pandemic when restrictions were in place; intervention delivery and evaluation processes have been adapted to address these conditions. Trial Registration: ISRCTN; ISRCTN21454676; Registered 22 June 2018; https://www.isrctn.com/ISRCTN21454676?q=21454676;

REACH-ASD: A UK randomised controlled trial of a new post-diagnostic psycho-education and acceptance and commitment therapy programme against treatment-as-usual for improving the mental health and adjustment of caregivers of children recently diagnosed with Autism Spectrum Disorder (preprint)

Background: Autism is a neurodevelopmental disability affecting over 1% of UK children. The period following a child’s autism diagnosis can present real challenges in adaptation for families. Twenty to fifty percent of caregivers show clinically significant levels of mental health need within the post-diagnostic period and on an ongoing basis. Best practice guidelines recommend timely post-diagnostic family support. Current provision is patchy, largely unevidenced, and a source of dissatisfaction for both families and professionals. There is a pressing need for an evidenced programme of post-diagnostic support focusing on caregiver mental health and adjustment, alongside autism psycho-education. This trial tests the clinical and cost effectiveness of a new brief manualised psychosocial intervention designed to address this gap. Methods: This is a multi-centre two-parallel-group single (researcher)-blinded randomised controlled trial of the Empower-Autism programme plus treatment-as-usual versus usual local post-diagnostic offer plus treatment-as-usual. Caregivers of children aged 2-15 years with a recent autism diagnosis will be recruited from North West England NHS or local authority centres. Randomization is individually by child, with one “index” caregiver per child, stratified by centre, using 2:1 randomisation ratio to assist recruitment and timely intervention. Empower-Autism is a group-based, manualised, post-diagnostic programme that combines autism psycho-education and psychotherapeutic components based on Acceptance and Commitment Therapy to support caregiver mental health, stress management and adjustment to their child’s diagnosis. The comparator is any usual local group-based post-diagnostic psycho-education offer. Receipt of services will be specified through health economic data. Primary outcome: caregiver mental health (General Health Questionnaire-30) at 52-week follow-up. Secondary outcomes: key caregiver measures (wellbeing, self-efficacy, adjustment, autism knowledge) at 12-, 26- and 52-week follow-up and family and child outcomes (wellbeing and functioning) at 52-week endpoint. Sample: N=380 (approximately 253 intervention/127 treatment-as-usual). Primary analysis will follow intention-to-treat principles using linear mixed models with random intercepts for group membership and repeated measures. Cost-effectiveness acceptability analyses will be over 52 weeks, with decision modelling to extrapolate to longer time periods. Discussion: If effective, this new approach will fill a key gap in the provision of evidence-based care pathways for autistic children and their families. Trial registration ISRCTN ID:45412843. https://www.isrctn.com/ISRCTNISRCTN45412843. Prospectively registered on 11 September 2019

Development of a staff support service in response to the Covid-19 crisis in Berkshire

This paper summarises reflections, learning and improvements from the experience of having developed a staff support service for frontline healthcare staff in response to the Covid-19 outbreak in Berkshire. [ABSTRACT FROM AUTHOR] Copyright of Clinical Psychology Forum is the property of British Psychological Society and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)