Parent-mediated intervention in infants with an elevated likelihood for autism reduces dwell time during a gaze-following task.

Cognitive markers may in theory be more sensitive to the effects of intervention than overt behavioral measures. The current study tests the impact of the Intervention with the British Autism Study of Infant Siblings-Video Interaction for Promoting Positive Parenting (iBASIS-VIPP) on an eye-tracking measure of social attention: dwell time to the referred object in a gaze following task. The original two-site, two-arm, assessor-blinded randomized controlled trial (RCT) of this intervention to increase parental awareness, and responsiveness to their infant, was run with infants who have an elevated familial likelihood for autism (EL). Fifty-four EL infants (28 iBASIS-VIPP intervention, 26 no intervention) were enrolled, and the intervention took place between 9 months (baseline) and 15 months (endpoint), with gaze following behavior measured at 15 months. Secondary intention to treat (ITT) analysis showed that the intervention was associated with significantly reduced dwell time to the referent of another person's gaze (ß = -0.32, SE = 0.14, p = 0.03) at 15-month treatment endpoint. Given the established link between gaze following and language, the results are considered in the context of a previously reported, non-significant and transient trend toward lower language scores at the treatment endpoint (Green et al. (2015) The Lancet Psychiatry, 2(2), 133-140). Future intervention trials should aim to include experimental cognitive measures, alongside behavioral measures, to investigate mechanisms associated with intervention effects.

Single Center Neurosurgical Outcomes and Trends in Endoscopic Endonasal Resection of 297 Sellar/Suprasellar Tumors Stratified by Duration of Neurosurgical Career.

BACKGROUND/OBJECTIVE: Endoscopic endonasal transsphenoidal surgery (EETS) is a common treatment for sellar and suprasellar tumors. While endoscopic training has improved over the years and formal fellowship training is now broadly available, the operative nuances of EETS conjectures the existence a learning curve as a neurosurgeon matures with experience. We aim to evaluate operative outcomes of 3 different experience levels of neurosurgeons over time at a single institution. METHODS: We reviewed all adult patients who underwent EETS at Loyola University Medical Center by 3 early career, 1 midcareer, and 2 late career neurosurgeons from 2007 to 2023. A comparative assessment of patient demographics, tumor features, and surgical outcomes was done using metrics such as length of surgery, rates of gross total resection (GTR) and symptomatic improvement, new postoperative steroid dependence, and development of diabetes insipidus (DI). T-tests and χ2 were used to statistically evaluate the study cohorts. RESULTS: A total of 297 patients underwent EETS. One hundred three (35%) were operated on by an early career, 122 (41%) by a mid-career, and 72 (24%) by a late career neurosurgeon. Late-career surgeons had shorter operation times (144 vs. 180 minutes with early and mid-career, P = 0.029) and increased GTR rates (P = 0.008). There were no significant differences between the symptomatic improvement rates amongst various surgeon experience levels. Although not statistically significant, early-career neurosurgeons had lower rates of new postoperative steroid dependence. Patients of early career surgeons experienced significantly less DI (15% vs. 40%, P = 0.004). CONCLUSIONS: Late-career neurosurgeons had shorter operation lengths, achieved higher rates of GTR, and their patients experienced significantly higher rates of DI. Overall outcomes remained stable throughout the course of 16 years between different surgeon experience levels.

Mid-childhood autism sibling recurrence in infants with a family history of autism.

Autism sibling recurrence in prospective infant family history studies is ~20% at 3 years but systematic follow-up to mid-childhood is rare. In population and clinical cohorts autism is not recognized in some children until school-age or later. One hundred and fifty-nine infants with an older sibling with autism underwent research diagnostic assessments at 3 years and mid-childhood (6 to 12 years (mean 9)). We report the autism sibling recurrence rate in mid-childhood and compare developmental and behavioral profiles at mid-childhood and 3 years in those with earlier versus later recognized autism, and those who had, or had not, received a community autism diagnosis. The autism recurrence rate in this sample in mid-childhood was 37.1%, 95% CI [29.9%, 44.9%] and higher in boys than girls. Around half of those diagnosed with autism in mid-childhood had not received a diagnosis at 3 years. Later, diagnosis was more common in girls than boys. While some had sub-threshold symptoms at 3, in others late diagnosis followed a largely typical early presentation. Sibling recurrence based on community clinical diagnosis was 24.5%, 95% CI [18.4%, 31.9%]. Those who also had a community diagnosis tended to be older, have lower adaptive function and higher autism and inattention symptoms. Notwithstanding limitations of a single site study, modest sample size and limits to generalisability, autism sibling recurrence in family history infants may be higher in mid-childhood than in studies reporting diagnostic outcome at 3 years. Findings have implications for families and clinical services, and for prospective family history studies.

Identifying vulnerable mother-infant dyads: a psychometric evaluation of two observational coding systems using varying interaction periods.

Introduction: Clinical services require feasible assessments of parent-infant interaction in order to identify dyads requiring parenting intervention. We assessed the reliability and predictive validity of two observational tools and tested whether briefer forms could be identified which retain acceptable psychometric properties over short observation periods. Methods: A stratified high-risk community sample of 250 mother-infant dyads from The Wirral Child Health and Development Study completed 7-min play-based interaction at 6-8 months. Film-footage was independently coded by two trained raters using PIIOS and NICHD-SECCYD systems. Incremental predictive validity was assessed from 3, 5 and 7 min observation to attachment outcomes (Strange Situation; 14 months) and infant mental health (BITSEA; 14 and 30 months). Results: Excellent inter-rater reliability was evident at code and subscale level for each tool and observation period. Stability of within-rater agreement was optimal after 5 min observation. ROC analysis confirmed predictive (discriminant) validity (AUCs >0.70) to top decile age 2 mental health outcomes for PIIOS total score and a brief 3-item composite from NICHD-SECCYD (sensitivity, intrusiveness, positive regard; NICHD-3), but not to attachment outcomes. Logistic regression showed dyads rated at-risk for externalizing problems using NICHD-3 were also at significantly higher risk for insecurity at 14 months (OR = 2.7, p = 0.004). Conclusion: PIIOS total and NICHD-3 ratings from 5 min observation are both reliable and valid tools for use in clinical practice. Findings suggest NICHD-3 may have greater utility due to its comparative brevity to train and code, with suitability for use over a broader developmental time frame (3-24 months).

Patients at Greatest Risk of Missing Initial 1-Year Follow-Up After Pituitary Adenoma Resection.

OBJECTIVE: Routine evaluation and surveillance imaging after pituitary adenoma (PA) endoscopic endonasal transsphenoidal resection (EETS) is a neurosurgical practice to identify tumor recurrence. This study aims to identify social and clinical factors that may contribute to patients missing their initial 1-year follow-up appointment and provide guidance for targeted education to improve patient adherence with postoperative treatment plans, ultimately reducing unknown adenoma recurrence. METHODS: The authors performed a single-center retrospective review of patients who underwent EETS for PAs from 2007 to 2023. Patients were analyzed for sociodemographic factors, presenting symptoms, time to surgery, surgical outcomes, and adherence to postoperative follow-up visits at 1 year after surgery. RESULTS: A total of 256 patients with PAs treated by EETS met inclusion criteria; 218 (85%) of these patients attended 1-year follow-up, and 38 (15%) missed this visit. Twenty-nine (76%) individuals who missed their 1-year follow up were men (P = 0.006). Divorced/widowed/separated patients were 2 times more likely to miss their follow-up compared with their married counterparts (P = 0.008). Additional significant risk factors included older age, as the mean age for patients who missed their 1-year appointment was 60.1 years compared with 54.7 years (P = 0.028). Patients with visual field deficits at initial presentation were also less likely to follow-up at 1 year (P = 0.03). CONCLUSIONS: Risk factors of missed 1-year follow-up appointments after PA resection include male sex, divorced/widowed/separated marital status, older age, and the presence of visual deficits at initial presentation. Increased education efforts can be selectively aimed at these at-risk patient cohorts to improve patient compliance and reduce consequences of undetected tumor recurrence.

Generalisation of Social Communication Skills by Autistic Children During Play-Based Assessments Across Home, School and an Unfamiliar Research Setting.

We investigated autistic children's generalisation of social communication over time across three settings during a play-based assessment with different adults and explore the potential moderating effects on generalisation of age, nonverbal IQ and level of restricted and repetitive behaviours. The social communication abilities of 248 autistic children (2-11 years, 21% female, 22% single parent, 60% white) from three UK sites were assessed from 1984 video interactions in three contexts with three different interaction partners (parent/home, teaching assistant/school, researcher/clinic) at baseline, midpoint (+ 7m) and endpoint (+ 12m) within the Paediatric Autism Communication Trial-Generalised (PACT-G), a parent-mediated social communication intervention. Children's midpoint social communication at home generalised to school at midpoint and to clinic at endpoint. Generalisation was stronger from home to school and clinic than school to home and clinic. Generalisation was not moderated by age, nonverbal IQ or restricted and repetitive behaviour. Broader child development did not explain the pattern of results. The current study is the largest study to date to explore generalisation with autistic children and provides novel insight into their generalisation of social communication skills. Further research is needed to gain a more comprehensive understanding of facilitators of generalisation across settings and interaction partners in order to develop targeted strategies for interventions to enhance outcomes for young autistic children.

Editorial Perspective: The paradox of precision health in early development - building large samples to yield individual-level measures.

Precision health refers to the use of individualised biomarkers or predictive models to provide more tailored information about an individual's likely prognosis. For child psychiatry and psychology, we argue that this approach requires a focus on neurocognitive measures collected in early life and at large scale. However, the large sample sizes necessary to uncover individual-level predictors are currently rare in studies of neurodevelopmental conditions in early childhood. We recommend two strategies going forward: first, including neurocognitive measures in new national cohort studies, and second, synergising measures and data across currently funded longitudinal studies.

Understanding the Mechanisms of Cognitive Remediation on Recovery in People With Early Psychosis: A Mediation and Moderation Analysis.

BACKGROUND: To provide precision cognitive remediation therapy (CR) for schizophrenia, we need to understand whether the mechanism for improved functioning is via cognition improvements. This mechanism has not been rigorously tested for potential moderator effects. STUDY DESIGN: We used data (n = 377) from a randomized controlled trial using CIRCuiTS, a therapist-supported CR, with participants from first-episode psychosis services. We applied structured equation modeling to test whether: (1) CR hours explain the goal attainment functional outcome (GAS) at posttreatment, (2) global cognitive improvement mediates GAS, and if (3) total symptoms moderate the CR hours to cognitive improvement pathway, and/or negative symptoms moderate the cognition to functioning pathway, testing moderator effects via the mediator or directly on CR hours to functioning path. STUDY RESULTS: CR produced significant functioning benefit for each therapy hour (Coeff = 0.203, 95% CI 0.101-0.304, P < .001). The mediated path from CR hours to cognition and cognition to functioning was small and nonsignificant (Coeff = 0.014, 95% CI = -0.010, 0.037, P = .256). Total symptoms did not moderate the path to cognition (P = .211) or the direct path to outcome (P = .896). However, negative symptoms significantly moderated the effect of cognitive improvements on functioning (P = .015) with high negative symptoms reducing the functional gains of improved cognition. CONCLUSIONS: Although cognitive improvements were correlated with functioning benefit, they did not fully explain the positive effect of increased therapy hours on functioning, suggesting additional CR factors also contribute to therapy benefit. Negative symptoms interfere with the translation of cognitive improvements into functional gains so need consideration.

Association of difficulties in motor skills with longitudinal changes in social skills in children with autism spectrum disorder: findings from the ELENA French Cohort.

Developmental coordination disorder is a frequently co-occurring condition with autism spectrum disorder (ASD). Several cross-sectional studies have reported that children with difficulties in motor skills have a higher severity of ASD symptoms. This study aims to examine the association of difficulties in motor skills with longitudinal changes in social skills in children with ASD. Participants were drawn from the ELENA cohort, a French longitudinal cohort of children with ASD. Motor skills were assessed using the Movement Assessment Battery for Children at baseline, while social skills were measured using the Autism Diagnostic Observation Schedule (ADOS-2) and the Vineland Adaptive Behavior Scales (VABS-II) at both the baseline and a follow-up assessment conducted 3 years later. A composite score of social skills was created at baseline and at both time points. Linear regression models were performed to assess the association between difficulties in motor skills and changes in social skills, considering potential confounders such as IQ, age, and gender. The sample included 162 children with ASD. Children with difficulties in global motor skills (N = 114) showed less favorable trajectories in social skills compared to those without motor difficulties. The results were consistent when examining the ADOS-2 and the VABS-II separately. This study provides evidence for the negative impact of difficulties in motor skills on the longitudinal development of social skills in children with ASD. Interventions targeting motor difficulties may have broader benefits, extending beyond motor function to improve socialization.

No association between alexithymia and emotion recognition or theory of mind in a sample of adolescents enhanced for autistic traits.

LAY ABSTRACT: Alexithymia is a sub-clinical condition characterised by difficulties identifying and describing one's own emotions, which is found in many, but not all autistic people. The alexithymia hypothesis suggests that certain aspects of socio-cognitive functioning typically attributed to autism, namely difficulties in emotion recognition, might be better explained by often co-occurring alexithymia. It is important to understand what is specific to autism and what is due to other co-occurring characteristics to develop appropriate support for autistic people. However, most research on this topic has been conducted in adults, which limits our knowledge about the relevance of this theory to younger autistic populations. This study tested whether difficulties in emotion recognition and theory of mind traditionally associated with autism might be better explained by alexithymia in a sample of adolescents with and without a diagnosis of autism. Results found that difficulties in emotion recognition and theory of mind were both associated with autistic traits, and this was not accounted for by individual differences in levels of alexithymia. This research suggests that more work is needed to understand the applicability of the alexithymia hypothesis in younger populations, but that at least in adolescents and when using parent-report measures, alexithymia may not account for emotion recognition or theory of mind difficulties associated with autistic traits.

Cerebral arterial vasospasm complicating supratentorial meningioma resection: illustrative cases.

BACKGROUND: Cerebral arterial vasospasm is a rare complication after supratentorial meningioma resection. The pathophysiology of this condition may be similar to vasospasm after aneurysmal subarachnoid hemorrhage, and treatment options may be similar. OBSERVATIONS: The authors present two cases of cerebral vasospasm after supratentorial meningioma resection and perform a systematic literature review of similar cases. LESSONS: Cerebral arterial vasospasm after supratentorial meningioma resection may be associated with significant morbidity due to cerebral ischemia if not addressed in a timely manner. Treatment paradigms may be adopted from the management of arterial vasospasm associated with subarachnoid hemorrhage.

Experience and Reporting of Postnatal Depression Across Cultures: A Comparison Using Anchoring Vignettes of Mothers in the United Kingdom and India.

Postnatal mental health is often assessed using self-assessment questionnaires in epidemiologic research. Differences in response style, influenced by language, culture, and experience, may mean that the same response may not have the same meaning in different settings. These differences need to be identified and accounted for in cross-cultural comparisons. Here we describe the development and application of anchoring vignettes to investigate the cross-cultural functioning of the Edinburgh Postnatal Depression Scale (EPDS) in urban community samples in India (n = 549) and the United Kingdom (n = 828), alongside a UK calibration sample (n = 226). Participants completed the EPDS and anchoring vignettes when their children were 12-24 months old. In an unadjusted item-response theory model, UK mothers reported higher depressive symptoms than Indian mothers (d = 0.48, 95% confidence interval: 0.358, 0.599). Following adjustment for differences in response style, these positions were reversed (d = -0.25, 95% confidence interval: -0.391, -0.103). Response styles vary between India and the United Kingdom, indicating a need to take these differences into account when making cross-cultural comparisons. Anchoring vignettes offer a valid and feasible method for global data harmonization.

Mediation of 6-year mid-childhood follow-up outcomes after pre-school social communication (PACT) therapy for autistic children: randomised controlled trial.

BACKGROUND: There are very few mechanistic studies of the long-term impact of psychosocial interventions in childhood. The parent-mediated Paediatric Autism Communication Therapy (PACT) RCT showed sustained effects on autistic child outcomes from pre-school to mid-childhood. We investigated the mechanism by which the PACT intervention achieved these effects. METHODS: Of 152 children randomised to receive PACT or treatment as usual between 2 and 5 years of age, 121 (79.6%) were followed 5-6 years after the endpoint at a mean age of 10.5 years. Assessors, blind to the intervention group, measured Autism Diagnostic Observation Scale Calibrated Severity Score (ADOS CSS) for child autistic behaviours and Teacher Vineland (TVABS) for adaptive behaviour in school. Hypothesised mediators were child communication initiations with caregivers in a standard play observation (Dyadic Communication Measure for Autism, DCMA). Hypothesised moderators of mediation were baseline child non-verbal age equivalent scores (AE), communication and symbolic development (CSBS) and 'insistence on sameness' (IS). Structural equation modelling was used in a repeated measures mediation design. RESULTS: Good model fits were obtained. The treatment effect on child dyadic initiation with the caregiver was sustained through the follow-up period. Increased child initiation at treatment midpoint mediated the majority (73%) of the treatment effect on follow-up ADOS CSS. A combination of partial mediation from midpoint child initiations and the direct effect of treatment also contributed to a near-significant total effect on follow-up TVABS. No moderation of this mediation was found for AE, CSBS or IS. CONCLUSIONS: Early sustained increase in an autistic child's communication initiation with their caregiver is largely responsible for the long-term effects from PACT therapy on autistic and adaptive behaviour outcomes. This supports the theoretical logic model of PACT therapy but also illuminates fundamental causal processes of social and adaptive development in autism over time: early social engagement in autism can be improved and this can have long-term generalised outcome effects.

Evaluation of an adapted virtual training for master trainers of the WHO Caregiver Skills Training Program during the COVID-19 pandemic.

LAY ABSTRACT: The COVID-19 pandemic interrupted in-person professional activities. We developed and evaluated a remote training approach for master trainers of the Caregiver Skills Training Program. Master trainers support community practitioners, who in turn deliver the Caregiver Skills Training Program to caregivers of children with developmental delays or disabilities. The Caregiver Skills Training Program teaches caregivers how to use strategies to enhance learning and interactions during everyday play and home activities and routines with their child. The aim of this study was to evaluate the remote training of master trainers on Caregiver Skills Training Program. Twelve out of the 19 practitioners who enrolled in the training completed the study. The training consisted of a 5-day in-person session completed prior to the pandemic, followed by supporting participants' ability to identify Caregiver Skills Training Program strategies through coding of video recordings over 7 weekly meetings and group discussions and ended with participants independently coding a set of 10 videos for Caregiver Skills Training Program strategies. We found all but one participant was able to reliably identify Caregiver Skills Training Program strategies from video recordings despite a lack of ability to practice the Caregiver Skills Training Program strategies with children due to the pandemic. Taken together, our findings illustrate the feasibility and value of remote training approaches in implementing interventions.

Testing the social motivation theory of autism: the role of co-occurring anxiety.

BACKGROUND: The Social Motivation Theory proposes that social reward processing differences underlie autism. However, low social motivation has also been linked to higher anxiety. Given the co-occurrence between autism and anxiety, it is possible that anxiety drives the association between social motivation and autistic characteristics. This study tests the mechanisms underlying the association between social motivation and autistic traits. METHODS: Participants were 165 adolescents (71 male), aged 10-16 years, from the Mapping profiles of cognition, motivation and attention in childhood (C-MAPS) study, enriched for autistic traits (70 participants with an autism diagnosis, 37 male). Participants completed a battery of online experimental tasks, including a Choose-a-Movie social motivation task and social cognition measures (theory of mind; emotion recognition), alongside parent-reported child anxiety and autistic traits. RESULTS: Higher social motivation was significantly associated with lower autistic traits (ß = -.26, p < .001). Controlling for social cognition did not change the association between social motivation and autistic traits. Controlling for anxiety did significantly reduce the strength of the association (unstandardized coefficient change: p = .003), although social motivation remained associated with autistic traits (ß = -.16, p = .004). Post hoc analyses demonstrated differential sex-effects: The association between social motivation and autistic traits was significant only in the females (ß = -.38, p < .001), as was the attenuation by anxiety (unstandardized coefficient change: p < .001). CONCLUSIONS: The association between social motivation and autistic traits could be partially attributed to co-occurring anxiety. Sex-specific effects found in females may be due to environmental factors such as increased social demands in adolescent female relationships. Results are consistent with self-report by autistic individuals who do not identify as having reduced social motivation.

Three year outcomes in infants with a family history of autism and/or attention deficit hyperactivity disorder.

Background: Most research on early outcomes in infants with a family history (FH) of autism has focussed on categorically defined autism, although some have language and developmental delays. Less is known about outcomes in infants with a FH of attention deficit hyperactivity disorder (ADHD). Methods: Infants with and without a FH of autism and/or ADHD, due to a first-degree relative with either or both conditions, were recruited at 5 or 10 months. Three year outcomes were characterised using latent profile analysis (LPA) across measures of cognitive ability, adaptive functioning and autism, ADHD and anxiety traits (n = 131). We additionally ran an LPA using only autism and ADHD measures, and the broader LPA in an independent cohort (n = 139) and in both cohorts combined (n = 270). Results: A Low Developmental Level + High Behavioural Concerns class had elevated autism, ADHD and anxiety scores, low cognitive and adaptive function, and included all but one child with autism. A Low Developmental Level + Typical Behaviour class had average cognitive ability and typical behaviour but low adaptive function. A Typical Developmental Level + Some Behavioural Concerns class had average cognitive and adaptive function but slightly elevated behaviour scores. A High Developmental Level + Typical Behaviour class had above average cognitive ability and typical behaviour. All four LPAs identified classes characterised by combinations of either, or both, Low Development Level and elevated behaviour scores, as well as a typically developing class. No classes had elevated autism or ADHD traits in isolation. Conclusions: Some infants with a FH of autism or ADHD have atypical developmental and behavioural outcomes, but do not show strong autism or ADHD traits in isolation. The field needs to recalibrate aims and methods to embrace the broader transdiagnostic pattern of outcomes seen in these infants.

Screening for Attention Deficit Hyperactivity Disorder in Young Autistic Adults: The Diagnostic Accuracy of Three Commonly Used Questionnaires.

OBJECTIVE: Attention Deficit Hyperactivity Disorder (ADHD) is a common co-occurring condition in autistic individuals. ADHD is sometimes first recognised in young adulthood because ADHD symptoms may be misattributed to autism due to superficial overlap in presentation and diagnostic overshadowing. It should be investigated whether ADHD questionnaires are accurate in screening symptoms in young adults with autism. The current study examined this. METHODS: Participants were autistic young adults (N = 119) who took part in the Special Needs and Autism Project (SNAP), a population-based cohort. ADHD research diagnoses were obtained through the parent-informed Young Adult Psychiatric Assessment. Parents and young adults (self-report sample N = 71) completed ADHD questionnaires (Aberrant Behavior Checklist hyperactivity/non-compliance subscale, Conners Adult ADHD Rating Scales ADHD Index, and Strengths and Difficulties Questionnaire ADHD subscale). Receiver operating characteristic analyses were conducted to explore if the questionnaires discriminated ADHD cases from non-cases. To assess whether results varied by intellectual functioning, subgroup analyses were completed for those with an IQ ≥ 70 vs. <70. RESULTS: Weighted ADHD rates were high. Overall although the measures were performing at or close to adequate levels (area under the curve was 0.66 to 0.79 for parent-report and 0.70 to 0.65 for self-report), no single measure met adequate thresholds for sensitivity and specificity simultaneously. Tool performance was not different for those with an IQ ≥ 70 vs. <70. CONCLUSION: No single measure reported adequate performance for distinguishing ADHD from non-ADHD cases in this sample of young autistic adults. Use of current thresholds may lead to under-diagnosis.

Research Reviews: Advances in methods for evaluating child and adolescent mental health interventions.

BACKROUND: The evidence base for interventions for child mental health and neurodevelopment is weak and the current capacity for rigorous evaluation limited. We describe some of the challenges that make this field particularly difficult and expensive for evaluation studies. METHODS: We describe and review the use of novel study designs and analysis methodology for their potential to improve this situation. RESULTS: While several novel designs appeared ill-suited to our field, systematic review found others that offered potential but had yet to be widely adopted, some not at all. CONCLUSIONS: While funding is inevitably a constraint, we argue that improvements in the evidence base of both current and new treatments will only be achieved by the adoption of a number of these new technologies and study designs, the consistent application of rigorous constructive but demanding standards, and the engagement of the public, patients, clinical and research services to build a design, recruitment, and analysis infrastructure.

Satisfaction with cognitive remediation therapy: its effects on implementation and outcomes using the cognitive remediation satisfaction scale.

Cognitive Remediation (CR) improves cognition and functioning but is implemented in a variety of ways (independent, group and one-to-one). There is no information on whether service users find these implementation methods acceptable or if their satisfaction influences CR outcomes. We used mixed participatory methods, including focus groups, to co-develop a CR satisfaction scale. This was refined using three psychometric criteria (Cronbach's alpha, item discrimination, test-retest agreement) to select items. Factor analysis explored potential substructures. The refined measure was used in structural equation joint modelling to evaluate whether satisfaction with CR is affected by implementation method and treatment engagement or influences recovery outcome, using data from a randomised controlled trial. Four themes (therapy hours, therapist, treatment effects, computer use) generated a 31-item Cognitive Remediation Satisfaction scale (CRS) that reduced to 18 Likert items, 2 binary and 2 open-ended questions following psychometric assessment. CRS had good internal consistency (Alpha = 0.814), test-retest reliability (r= 0.763), and concurrent validity using the Working Alliance Inventory (r = 0.56). A 2-factor solution divided items into therapy engagement and therapy effects. Satisfaction was not related to implementation method but was significantly associated with CR engagement. Therapy hours were significantly associated with recovery, but there was no direct effect of satisfaction on outcome. Although satisfaction is important to therapy engagement, it has no direct effect on outcome. CR therapy hours directly affect outcome irrespective of which implementation model is used, so measuring satisfaction early might help to identify those who are likely to disengage. The study has mixed methods design.

Cognitive Remediation Works But How Should We Provide It? An Adaptive Randomized Controlled Trial of Delivery Methods Using a Patient Nominated Recovery Outcome in First-Episode Participants.

BACKGROUND AND HYPOTHESIS: Cognitive remediation (CR) benefits cognition and functioning in psychosis but we do not know the optimal level of therapist contact, so we evaluated the potential benefits of different CR modes. STUDY DESIGN: A multi-arm, multi-center, single-blinded, adaptive trial of therapist-supported CR. Participants from 11 NHS early intervention psychosis services were independently randomized to Independent, Group, One-to-One, or Treatment-as-usual (TAU). The primary outcome was functional recovery (Goal Attainment Scale [GAS]) at 15-weeks post randomization. Independent and TAU arms were closed after an interim analysis, and three informative contrasts tested (Group vs One-to-One, Independent vs TAU, Group + One-to-One vs TAU). Health economic analyses considered the cost per Quality Adjusted Life Year (QALY). All analyses used intention-to-treat principles. STUDY RESULTS: We analyzed 377 participants (65 Independent, 134 Group, 112 One-to-One, 66 TAU). GAS did not differ for Group vs One-to-One: Cohen's d: 0.07, -0.25 to 0.40 95% CI, P = .655; Independent vs TAU: Cohen's d: 0.07, -0.41 to 0.55 95% CI, P = .777. GAS and the cognitive score improved for Group + One-to-One vs TAU favoring CR (GAS: Cohen's d: 0.57, 0.19-0.96 95% CI, P = .003; Cognitive score: Cohens d: 0.28, 0.07-0.48 95% CI, P = .008). The QALY costs were £4306 for Group vs TAU and £3170 for One-to-One vs TAU. Adverse events did not differ between treatment methods and no serious adverse events were related to treatment. CONCLUSIONS: Both active therapist methods provided cost-effective treatment benefiting functional recovery in early psychosis and should be adopted within services. Some individuals benefited more than others so needs further investigation. TRIAL REGISTRATION: ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860Now closed.