Evaluating the Impact of Aevidum on Mental Health Knowledge, Attitudes, and Help-Seeking Behaviors in High School Students: A Mixed-Methods Study.

PURPOSE: To compare Aevidum's school mental health curriculum vs the curriculum plus Aevidum clubs in a mixed-methods study including pre/post surveys, a randomized clinical trial, and qualitative interviews. DESIGN: Concurrent mixed-methods: Aim 1) pre-post surveys evaluated curriculum only vs curriculum plus club schools separately regarding changes in knowledge, help-seeking, and school culture; Aim 2) randomized clinical trial compared curriculum only to curriculum plus club schools; Aim 3) qualitative school staff interviews enhanced understanding of school culture changes. SETTING: Curriculum delivered to 9th graders at ten Pennsylvania high schools; 5 schools randomized to start clubs. SUBJECTS: Students (surveys), staff (interviews). INTERVENTION: Aevidum curriculum plus/minus club. MEASURES: Aim 1, mixed effects linear and logistic regression models for longitudinal data were used to analyze survey items at each time point. Aim 2, the same regression models were used, except models included a fixed-effect for group and group by time interaction effect. Aim 3, interviews were transcribed; a codebook was developed followed by thematic analysis. RESULTS: Pre-survey 2557 respondents; 49% female, 86% non-Hispanic white. Post-survey 737 (29% response rate). Aim 1, pre-post (Likert responses, larger numbers favorable) demonstrated increased student knowledge to identify depression (4.26 [4.19-4.33] to 4.59 [4.47-4.71], P < .001) and help a friend access support (4.30 [4.21-4.38] to 4.56 [4.40-4.71], P = .001). Help-seeking increased for phone helplines (1.61 [1.57-1.66] to 1.78 [1.70-1.86], P < .001), crisis textlines (1.60 [1.55-1.64] to 1.78 [1.70-1.86], P < .001), internet/websites (1.80 [1.75-1.85] to 1.99 [1.90-2.08], P < .001), school counselors (P = .005) and teachers (.013). Aim 2, no significant differences in knowledge, help-seeking or culture between curriculum only vs curriculum plus club schools. Aim 3, staff (n = 17) interviews supported reduced stigma and increased mental health referrals. CONCLUSIONS: Aevidum's curriculum improved mental health knowledge and help-seeking; adding the club did not significantly change responses. Staff identified positive school culture impacts. Limitations include the lower post-survey response.

Evaluation of a stakeholder advisory board for an adolescent mental health randomized clinical trial.

INTRODUCTION: Community engagement in research is widely accepted as best practice, despite gaps in existing frameworks to evaluate its process, context, and impact on research. The Screening in High Schools to Identify, Evaluate, and Lower Depression (SHIELD) study evaluated the use of a school-based major depressive disorder screening tool in the identification of symptoms and treatment initiation among adolescents, and was developed, implemented, and disseminated in partnership with a Stakeholder Advisory Board (SAB). We summarize outcomes of the evaluation strategy applied through our partnership with the SAB and explore gaps in the available engagement evaluation tools for mixed stakeholder populations including youth. METHODS: SHIELD study SAB members (n = 13; adolescents, parents, mental health and primary care providers, and professionals from education and mental health organizations) advised on study design, implementation, and dissemination over a three-year period. Both SAB members and study team members (i.e., clinician researchers, project managers) were invited to quantitatively and qualitatively evaluate stakeholder engagement after each project year. At the conclusion of the study, SAB members and study team members were asked to evaluate the application of engagement principles in overall stakeholder engagement across the study period, using portions of the Research Engagement Survey Tool (REST). RESULTS: SAB members and study team members responded similarly when evaluating engagement process (i.e., valued on team, voice represented); means ranged from 3.9 to 4.8 out of 5 points across all three project years. Reported engagement within study-specific engagement activities (i.e., meetings, study newsletter) varied from year to year, with some discrepancy between SAB member and study team evaluations. Using REST, SAB members reported the alignment of their experience with key engagement principles the same or higher than study team members. Qualitative feedback at the conclusion of the study generally matched quantitative measures; adolescent SAB members, however, reported disengagement from stakeholder activities that was not accurately or effectively captured in evaluation strategies employed across the study period. CONCLUSIONS: Challenges exist in effectively engaging stakeholders and evaluating their engagement, particularly among heterogenous groups that include youth. Evaluation gaps should be addressed through the development of validated instruments that quantify the process, context, and impact of stakeholder engagement on study outcomes. Consideration should be given to collecting parallel feedback from stakeholders and study team members to fully understand the application and execution of engagement strategy.

We conducted a study (Screening in High Schools to Identify, Evaluate, and Lower Depression) to understand if an adolescent major depressive disorder screening tool delivered in the school setting aided in the identification of symptoms and treatment. We planned and conducted this study with the guidance of a stakeholders, including adolescents.At the end of each study year, we sent an evaluation survey to stakeholders to understand their experience, such as how appropriately the study included stakeholders and their perspectives. We also surveyed the team leading the study to understand their perspectives about stakeholder involvement. In general, both stakeholders and the study team reported feeling positive about stakeholder involvement; However, some stakeholders felt less involved as the study moved forward, and for some activities stakeholders and study team did not agree on how much the stakeholders were involved in study activities. Additionally, adolescent stakeholders reported low involvement in the study when completing the final evaluation, which, unfortunately, was not captured in the evaluations conducted in earlier study years.By evaluating the experiences of stakeholders, along with gathering perspectives of the study team, we were able to understand how well we involved stakeholders. However, additional questions remain unanswered, such as how best to involve adolescents as stakeholders, and how involving stakeholders impacted the results of our study. Evaluation tools to best understand these impacts are needed across the field of community-engaged research to answer these questions for future studies.

Leveraging Community-Engaged Research to Address Adolescent Depression with Pennsylvania Public Schools and Communities.

BACKGROUND: The prevalence of adolescent major depressive disorder increased from 8.3% in 2008 to 14.4% in 2018, and suicide is now the second leading cause of death among U.S. adolescents. OBJECTIVE: Describe the process of community-engaged research methods used to develop a randomized clinical trial (RCT) comparing the effectiveness of school-based universal depression screening on depression identification and treatment engagement, compared with standard symptom-based depression recognition. METHODS: We engaged stakeholders with personal or professional expertise and schools enrolled in the study. Qualitative methods aimed to elucidate barriers and opportunities during RCT development. RESULTS: Stakeholders were instrumental in all phases of RCT development. Qualitative feedback from participating schools, students, and parents informed RCT development and implementation. CONCLUSIONS: The inclusion of community-engaged research methods provided opportunities to collaboratively address barriers to RCT design and implementation with school communities. This dialogue was invaluable in establishing relationships to further address mental health and other controversial adolescent health topics in future research.

Dimensional structure of first episode psychosis.

AIM: Current diagnostic systems, DSM-5 and ICD-10, still adopt a categorical approach to classify psychotic disorders. The present study was aimed at investigating the structure of psychotic symptomatology in both affective and non-affective psychosis from a dimensional approach. METHODS: Participants with a first episode psychosis (FEP) were recruited from a cluster-randomized controlled trial (GET-UP PIANO TRIAL), offered to all Community Mental Health Centres (CMHCs) located across two northern Italian regions. After clinical stabilization, patients were assessed with a comprehensive set of psychopathological measures including the Positive and Negative Syndrome Scale, the Hamilton Depression Rating Scale and the Bech-Rafaelsen Mania Rating Scale. A two-step cluster analysis was performed. RESULTS: Overall, 257 FEP patients (male, n = 171, 66.5%; mean age = 24.96 ± 4.56) were included in the study. The cluster analysis revealed a robust four-cluster solution: delusional-persecutory (n = 82; 31.9%), depressed (n = 95; 37%), excited (n = 26; 10.1%) and negative-disorganized (n = 54; 21%), thus suggesting a quadripartite structure with both affective and non-affective dimensions. Among non-affective dimensions, negative and disorganization symptoms constituted a unique construct apart from positive symptoms. CONCLUSIONS: Symptom dimensions may represent a useful tool for dissecting the indistinct and non-specific psychopathology of FEP in order to better target specific interventions.

Prosody abilities in a large sample of affective and non-affective first episode psychosis patients.

OBJECTIVE: Prosody comprehension deficits have been reported in major psychoses. It is still not clear whether these deficits occur at early psychosis stages. The aims of our study were to investigate a) linguistic and emotional prosody comprehension abilities in First Episode Psychosis (FEP) patients compared to healthy controls (HC); b) performance differences between non-affective (FEP-NA) and affective (FEP-A) patients, and c) association between symptoms severity and prosodic features. METHODS: A total of 208 FEP (156 FEP-NA and 52 FEP-A) patients and 77 HC were enrolled and assessed with the Italian version of the "Protocole Montréal d'Evaluation de la Communication" to evaluate linguistic and emotional prosody comprehension. Clinical variables were assessed with a comprehensive set of standardized measures. RESULTS: FEP patients displayed significant linguistic and emotional prosody deficits compared to HC, with FEP-NA showing greater impairment than FEP-A. Also, significant correlations between symptom severity and prosodic features in FEP patients were found. CONCLUSIONS: Our results suggest that prosodic impairments occur at the onset of psychosis being more prominent in FEP-NA and in those with severe psychopathology. These findings further support the hypothesis that aprosodia is a core feature of psychosis.

Immune and metabolic alterations in first episode psychosis (FEP) patients.

The molecular underpinnings associated to first episode psychosis (FEP) remains to be elucidated, but compelling evidence supported an association of FEP with blood alterations in biomarkers related to immune system, growth factors and metabolism regulators. Many of these studies have not been already confirmed in larger samples or have not considered the FEP diagnostic subgroups. In order to identify biochemical signatures of FEP, the serum levels of the growth factors BDNF and VEGF, the immune regulators IL-1RA, IL-6, IL-10 and IL-17, RANTES/CCL5, MIP-1b/CCL4, IL-8 and the metabolic regulators C-peptide, ghrelin, GIP, GLP-1, glucagon, insulin, leptin, PAI-1, resistin and visfatin were analysed in 260 subjects collected in the GET UP project. The results indicated an increase of MIP-1b/CCL4, VEGF, IL-6 and PAI-1, while IL-17, ghrelin, glucagon and GLP-1 were decreased in the whole sample of FEP patients (p < 0.01 for all markers except for PAI-1 p < 0.05). No differences were evidenced for these markers among the diagnostic groups that constitute the FEP sample, whereas IL-8 is increased only in patients with a diagnosis of affective psychosis. The principal component analysis (PCA) and variable importance analysis (VIA) indicated that MIP-1b/CCL4, ghrelin, glucagon, VEGF and GLP-1 were the variables mostly altered in FEP patients. On the contrary, none of the analysed markers nor a combination of them can discriminate between FEP diagnostic subgroups. These data evidence a profile of immune and metabolic alterations in FEP patients, providing new information on the molecular mechanism associated to the psychosis onset for the development of preventive strategies and innovative treatment targets.

Family Burden, Emotional Distress and Service Satisfaction in First Episode Psychosis. Data from the GET UP Trial.

Background: Literature has documented the role of family in the outcome of chronic schizophrenia. In the light of this, family interventions (FIs) are becoming an integral component of treatment for psychosis. The First Episode of Psychosis (FEP) is the period when most of the changes in family atmosphere are observed; unfortunately, few studies on the relatives are available. Objective: To explore burden of care and emotional distress at baseline and at 9-month follow-up and the levels of service satisfaction at follow-up in the two groups of relatives (experimental treatment EXP vs. treatment as usual TAU) recruited in the cluster-randomized controlled GET UP PIANO trial. Methods: The experimental treatment was provided by routine public Community Mental Health Centers (Italian National Health Service) and consisted of Treatment as Usual plus evidence-based additional treatment (Cognitive Behavioral Therapy for psychosis for patients, Family Intervention for psychosis, and Case Management). TAU consisted of personalized outpatient psychopharmacological treatment, combined with non-specific supportive clinical management and informal support/educational sessions for families. The outcomes on relatives were assessed by the Involvement Evaluation Questionnaire (IEQ-EU), the General Health Questionnaire (GHQ-12), and the Verona Service Satisfaction Scale (VSSS-EU). Differences within and between groups were evaluated. Results: At baseline, 75 TAU and 185 EXP caregivers were assessed. In the experimental group 92% of relatives participated in at least 1 family session. At follow-up both groups experienced improvement in all IEQ and GHQ items, but caregivers belonging to the EXP arm experienced a significantly greater change in 10 IEQ items (mainly pertaining to the "Tension" dimension) and in GHQ items. Due to the low sample size, a significant effectiveness was only observed for 2 IEQ items and 1 GHQ-12 item. With respect to VSSS data at follow-up, caregivers in the EXP arm experienced significantly greater satisfaction in 8 items, almost all pertaining to the dimensions "Relatives' Involvement" and "Professionals' Skills and Behavior." Conclusions: The Family intervention for psychosis delivered in the GET UP PIANO trial reduced family burden of illness and improved emotional distress and satisfaction with services. These results should encourage to promote FIs on caregivers of first-episode psychosis patients.

Predictors and moderators of treatment outcome in patients receiving multi-element psychosocial intervention for early psychosis: results from the GET UP pragmatic cluster randomised controlled trial.

BackgroundThe GET UP multi-element psychosocial intervention proved to be superior to treatment as usual in improving outcomes in patients with first-episode psychosis (FEP). However, to guide treatment decisions, information on which patients may benefit more from the intervention is warranted.AimsTo identify patients' characteristics associated with (a) a better treatment response regardless of treatment type (non-specific predictors), and (b) a better response to the specific treatment provided (moderators).MethodSome demographic and clinical variables were selected a priori as potential predictors/moderators of outcomes at 9 months. Outcomes were analysed in mixed-effects random regression models. (Trial registration: ClinicalTrials.gov, NCT01436331)ResultsAnalyses were performed on 444 patients. Education, duration of untreated psychosis, premorbid adjustment and insight predicted outcomes regardless of treatment. Only age at first contact with the services proved to be a moderator of treatment outcome (patients aged ⩾35 years had greater improvement in psychopathology), thus suggesting that the intervention is beneficial to a broad array of patients with FEP.ConclusionsExcept for patients aged over 35 years, no specific subgroups benefit more from the multi-element psychosocial intervention, suggesting that this intervention should be recommended to all those with FEP seeking treatment in mental health services.

Classification of first-episode psychosis in a large cohort of patients using support vector machine and multiple kernel learning techniques.

First episode psychosis (FEP) patients are of particular interest for neuroimaging investigations because of the absence of confounding effects due to medications and chronicity. Nonetheless, imaging data are prone to heterogeneity because for example of age, gender or parameter setting differences. With this work, we wanted to take into account possible nuisance effects of age and gender differences across dataset, not correcting the data as a pre-processing step, but including the effect of nuisance covariates in the classification phase. To this aim, we developed a method which, based on multiple kernel learning (MKL), exploits the effect of these confounding variables with a subject-depending kernel weighting procedure. We applied this method to a dataset of cortical thickness obtained from structural magnetic resonance images (MRI) of 127 FEP patients and 127 healthy controls, who underwent either a 3Tesla (T) or a 1.5T MRI acquisition. We obtained good accuracies, notably better than those obtained with standard SVM or MKL methods, up to more than 80% for frontal and temporal areas. To our best knowledge, this is the largest classification study in FEP population, showing that fronto-temporal cortical thickness can be used as a potential marker to classify patients with psychosis.

Feasibility and Effectiveness of a Multi-Element Psychosocial Intervention for First-Episode Psychosis: Results From the Cluster-Randomized Controlled GET UP PIANO Trial in a Catchment Area of 10 Million Inhabitants.

Integrated multi-element psychosocial interventions have been suggested to improve the outcomes of first-episode psychosis (FEP) patients, but they have been studied primarily in experimental settings and in nonepidemiologically representative samples. Thus, we performed a cluster-randomized controlled trial, comparing an integrated multi-element psychosocial intervention, comprising cognitive behavioral therapy, family intervention, and case management, with treatment as usual (TAU) for FEP patients in 117 community mental health centers (CMHCs) in a large area of northern Italy (10 million inhabitants). The randomized units (clusters) were the CMHCs, and the units of observation the patients (and, when available, their family members). The primary hypotheses were that add-on multicomponent intervention: (1) results in greater improvements in symptoms, as assessed with positive and negative syndrome scale and (2) reduces in-hospital stay, based on days of hospitalization over the 9-month follow-up. Four hundred and forty-four FEP patients received the intervention or TAU and were assessed at baseline and 9 months. Based on the retention rates of patients (and families) in the experimental arm, multi-element psychosocial interventions can be implemented in routine mental health services. Regarding primary outcomes, patients in the experimental arm showed greater reductions in overall symptom severity, while no difference could be found for days of hospitalization. Among the secondary outcomes, greater improvements were detected in the experimental arm for global functioning, emotional well-being, and subjective burden of delusions. No difference could be found for service disengagement and subjective burden of auditory hallucinations. These findings support feasibility and effectiveness of early interventions for psychosis in generalist mental health services.

A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial.

BACKGROUND: Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in 'real-world' services. METHODS/DESIGN: The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers' patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrollment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms' severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible, but every effort will be made to preserve the independency of the raters. We expect that this study will generate evidence on the best treatments for FEP, and will identify barriers that may hinder its feasibility in 'real-world' clinical settings, patient/family conditions that may render this intervention ineffective or inappropriate, and clinical, psychological, environmental, and service organization predictors of treatment effectiveness, compliance, and service satisfaction.