Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial.

BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed to manage anxiety in adults with an autism diagnosis. However, their effectiveness and adverse effect profile in the autistic population are not well known. This trial aims to determine the effectiveness and cost-effectiveness of the SSRI sertraline in reducing symptoms of anxiety and improving quality of life in adults with a diagnosis of autism compared with placebo and to quantify any adverse effects. METHODS: STRATA is a two-parallel group, multi-centre, pragmatic, double-blind, randomised placebo-controlled trial with allocation at the level of the individual. It will be delivered through recruiting sites with autism services in 4 regional centres in the United Kingdom (UK) and 1 in Australia. Adults with an autism diagnosis and a Generalised Anxiety Disorder Assessment (GAD-7) score ≥ 10 at screening will be randomised 1:1 to either 25 mg sertraline or placebo, with subsequent flexible dose titration up to 200 mg. The primary outcome is GAD-7 scores at 16 weeks post-randomisation. Secondary outcomes include adverse effects, proportionate change in GAD-7 scores including 50% reduction, social anxiety, obsessive-compulsive symptoms, panic attacks, repetitive behaviours, meltdowns, depressive symptoms, composite depression and anxiety, functioning and disability and quality of life. Carer burden will be assessed in a linked carer sub-study. Outcome data will be collected using online/paper methods via video call, face-to-face or telephone according to participant preference at 16, 24 and 52 weeks post-randomisation, with brief safety checks and data collection at 1-2, 4, 8, 12 and 36 weeks. An economic evaluation to study the cost-effectiveness of sertraline vs placebo and a QuinteT Recruitment Intervention (QRI) to optimise recruitment and informed consent are embedded within the trial. Qualitative interviews at various times during the study will explore experiences of participating and taking the trial medication. DISCUSSION: Results from this study should help autistic adults and their clinicians make evidence-based decisions on the use of sertraline for managing anxiety in this population. TRIAL REGISTRATION: ISRCTN, ISRCTN15984604 . Registered on 08 February 2021. EudraCT 2019-004312-66. ANZCTR ACTRN12621000801819. Registered on 07 April 2021.

Individual placement and support focusing on employment and education for young people at clinical high risk of psychosis: A feasibility study.

OBJECTIVE: This study aimed to assess the feasibility of implementing Individual Placement and Support (IPS) with a focus on educational and employment goals, within a clinical service for the early detection of individuals at clinical high risk (CHR) of psychosis. METHOD: Between June 2019 and April 2021, participants were recruited and received up to 6 (± 2) months support. Primary outcome: Enrolled participants, attended sessions, and disengagement rates were analyzed to assess feasibility. SECONDARY OUTCOMES: Enrollment in mainstream education or/and employment, hours spent working or/and studying, salary, level of functioning, and self-efficacy at baseline and follow-up were compared. RESULTS: Thirty-one participants were recruited, 13 of whom were remotely recruited after the first COVID-19 lockdown. Dropout rates were relatively low (16.1%), and 26 participants (83.9%) completed the program. Each participant received on average nine sessions (M = 9.65; SD = 4.92). Secondary outcomes: At follow-up, 73.1% participants were employed, working on average more hours per week, t(25) = -2.725; p = .012, and were earning significantly more money, t(25) = -3.702; p = .001, compared to baseline. Gains in educational outcomes were less clear. Global Assessment of Functioning, t = 248.50; p = .001, and Social Occupational Functioning, t(25) = -3.273; p = .003, were significantly higher at 6-month follow-up compared to baseline. No differences were found in participants' self-efficacy. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Findings indicate that research procedures are appropriate and that IPS implementation within a CHR clinical team is feasible. Secondary outcomes also suggest that IPS may be a beneficial intervention for young people at CHR. A longer follow-up might be needed to assess its impact on educational outcomes. (PsycInfo Database Record (c) 2024 APA, all rights reserved).