Linking Primary Care to Community-Based Mental Health Resources via Family Navigation and Phone-Based Care Coordination.

Family navigation (FN) and phone-based care coordination may improve linkages from primary care to community-based mental health referrals, but research on their differential impact is limited. This mixed-methods study compared FN and phone-based care coordination in connecting families to mental health services from primary care. Families of children (56.3% male, mean age = 10.4 years, 85.4% Black) were sequentially assigned to either receive FN through a family-run organization or phone-based coordination via the child psychiatry access program (CPAP). Caregiver-reported children's mental health improved in both groups and both groups were satisfied with services. More families in the CPAP group had appointments made or completed (87%) than families in the FN group (71%) though the difference was not statistically significant. Future research with a larger sample that matches family needs and preferences (e.g., level and type of support) with navigation services would be beneficial.

Impact of pet dog or cat exposure during childhood on mental illness during adolescence: a cohort study.

BACKGROUND: In our prior study of 643 children, ages 4-11 years, children with pet dogs had lower anxiety scores than children without pet dogs. This follow-up study examines whether exposure to pet dogs or cats during childhood reduces the risk of adolescent mental health (MH) disorders. METHODS: Using a retrospective cohort study design, we merged our prior study database with electronic medical record (EMR) data to create an analytic database. Common MH diagnoses (anxiety, depression, ADHD) occurring from the time of prior study enrollment to 10/27/21 were identified using ICD-9 and ICD-10 codes. We used proportional hazards regression to compare time to MH diagnoses, between youths with and without pets. From 4/1/20 to 10/27/21, parents and youth in the prior study were interviewed about the amount of time the youth was exposed to a pet and how attached s/he was to the pet. Exposure included having a pet dog at baseline, cumulative exposure to a pet dog or cat during follow-up, and level of pet attachment. The main outcomes were anxiety diagnosis, any MH diagnosis, and MH diagnosis associated with a psychotropic prescription. RESULTS: EMR review identified 571 youths with mean age of 14 years (range 11-19), 53% were male, 58% had a pet dog at baseline. During follow-up (mean of 7.8 years), 191 children received a MH diagnosis: 99 were diagnosed with anxiety (52%), 61 with ADHD (32%), 21 with depression (11%), 10 with combined MH diagnoses (5%). After adjusting for significant confounders, having a pet dog at baseline was associated with lower risk of any MH diagnosis (HR = 0.74, p = .04) but not for anxiety or MH diagnosis with a psychotropic prescription. Among the 241 (42%) youths contacted for follow-up, parent-reported cumulative exposure to pet dogs was borderline negatively associated with occurrence of any MH diagnosis (HR = 0.74, p = .06). Cumulative exposure to the most attached pet (dog or cat) was negatively associated with anxiety diagnosis (HR = 0.57, p = .006) and any MH diagnosis (HR = 0.64, p = .013). CONCLUSION: Cumulative exposure to a highly attached pet dog or cat is associated with reduced risk of adolescent MH disorders.

Discovering Common Elements of Empirically Supported Self-Help Interventions for Depression in Primary Care: a Systematic Review.

BACKGROUND: Although the efficacy of self-help cognitive-behavioral therapy (CBT) for depression has been well established, its feasibility in primary care settings is limited because of time and resource constraints. The goal of this study was to identify common elements of empirically supported (i.e., proven effective in controlled research) self-help CBTs and frameworks for effective use in practice. METHODS: Randomized controlled trials (RCTs) for self-help CBTs for depression in primary care were systematically identified in Pubmed, PsycINFO, and CENTRAL. The distillation and matching model approach was used to abstract commonly used self-help techniques (practice elements). Study contexts associated with unique combinations of intervention elements were explored, including total human support dose (total face-to-face, telephone, and personalized email contact time recommended by the protocol), effective symptom domain (depression vs. general psychological distress), and severity of depression targeted by the study. Relative contribution to intervention success was estimated for individual elements and human support by conditional probability (CP, proportion of the number of times each element appeared in a successful intervention to the number of times it was used in the interventions identified by the review). RESULTS: Twenty-one interventions (12 successful) in 20 RCTs and 21 practice elements were identified. Cognitive restructuring, behavioral activation, and homework assignment were elements appearing in > 80% of successful interventions. The dose of human support was positively associated with the proportion of interventions that were successful in a significant linear fashion (CPs: interventions with no support, 0.20; 1-119 min of support, 0.60; 120 min of support, 0.83; p = 0.042). In addition, human support increased the probability of success for most of the extracted elements. Only social support activation, homework assignment, and interpersonal skills were highly successful (CPs ≥ 0.60) when minimal support was provided. DISCUSSION: These findings suggest that human support is an important component in creating an evidence-informed brief self-help program compatible with primary care settings.

The Mental Health Training Intervention for School Nurses and Other Health Providers in Schools.

School nurses encounter many students presenting with mental health needs. However, school nurses report that they need additional training and resources to be able to support student mental health. This study involved a multilevel, stakeholder-driven process to refine the Mental Health Training Intervention for Health Providers in Schools (MH-TIPS), an in-service training and implementation support system for school health providers, including school nurses, to increase their competence in addressing student mental health concerns. Findings highlighted the importance of mental health content including assessment, common factors of positive therapeutic mental health interactions, common elements of evidence-based mental health practice, and resource and referral mapping. Additionally, multifaceted ongoing professional development processes were indicated. Study findings indicate that, with recommended modifications, the MH-TIPS holds promise as a feasible, useful intervention to support school nurse practice and ultimately impact student mental health and educational outcomes.

What's known about implementing co-located paediatric integrated care: a scoping review.

Several studies have demonstrated clinical benefits of integrated care for a range of child and adolescent mental health outcomes. However, there is a significant gap between the evidence for efficacy of integrated care interventions vs their implementation in practice. While several studies have examined large-scale implementation of co-located integrated care for adults, much less is known for children. The goal of this scoping review was to understand how co-located mental health interventions targeting children and adolescents have been implemented and sustained. The literature was systematically searched for interventions targeting child and adolescent mental health that involved a mental health specialist co-located in a primary care setting. Studies reporting on the following implementation outcomes were included: acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration, and sustainability. This search identified 34 unique studies, including randomized controlled trials, observational studies, and survey/mixed method approaches. Components facilitating implementation of on-site integrated behavioural healthcare included interprofessional communication and collaboration at all stages of implementation; clear protocols to facilitate intervention delivery; and co-employment of integrated care providers by specialty clinics. Some studies found differences in service use by demographic factors, and others reported funding challenges affecting sustainability, warranting further study.

The study of effect moderation in youth suicide-prevention studies.

PURPOSE: Suicide is now the second leading cause of death among persons between the ages of adolescents and emerging adults and rates have increased despite more funding and broader implementation of youth suicide-prevention programs. A systematic review was conducted focusing on identifying youth suicide-prevention studies within the United States. This paper reports on the methods utilized for understanding possible moderators of suicide-prevention program outcomes. METHODS: We searched six databases from 1990 through August 2017 to identify studies of suicide-preventive interventions among those under age 26 years. Two independent team members screened search results and sequentially extracted information related to statistical methods of moderation analyses. RESULTS: 69 articles were included in the systematic review of which only 17 (24.6%) explored treatment effect heterogeneity using moderation analysis. The most commonly used analytic tool was regression with an interaction term. The moderators studied included demographic characteristics such as gender and ethnicity as well as individual characteristics such as traumatic stress exposure and multiple prior suicide attempts. CONCLUSIONS: With a greater emphasis from the federal government and funding agencies on precision prevention, understanding which prevention programs work for specific subgroups is essential. Only a small percentage of the reviewed articles assessed moderation effects. This is a substantial research gap driven by sample size or other limitations which have impeded the identification of intervention effect heterogeneity.

The role of organizational context in the implementation of a statewide initiative to integrate mental health services into pediatric primary care.

BACKGROUND: Although there is evidence that mental health services can be delivered in pediatric primary care with good outcomes, few changes in service delivery have been seen over the past decade. Practices face a number of barriers, making interventions that address determinants of change at multiple levels a promising solution. However, these interventions may need appropriate organizational contexts in place to be successfully implemented. PURPOSE: The objective of this study was to test whether organizational context (culture, climate, structures/processes, and technologies) influenced uptake of a complex intervention to implement mental health services in pediatric primary care. METHODOLOGY/APPROACH: We incorporated our research into the implementation and evaluation of Ohio Building Mental Wellness Wave 3, a learning collaborative with on-site trainings and technical assistance supporting key drivers of mental health care implementation. Simple linear regression was used to test the effects of organizational context and external or fixed organizational characteristics on program uptake. RESULTS: Culture, structure/processes, and technologies scores indicating a more positive organizational context for mental health at the project's start, as well as general cultural values that were more group/developmental, were positively associated with uptake. Patient-centered medical home certification and use of electronic medical records were also associated with greater uptake. Changes in context over the course of Building Mental Wellness did not influence uptake. CONCLUSION: Organizational culture, structures/processes, and technologies are important determinants of the uptake of activities to implement mental health services in pediatric primary care. Interventions may be able to change these aspects of context to make them more favorable to integration, but baseline characteristics more heavily influence the more proximal uptake of program activities. PRACTICE IMPLICATIONS: Pediatric primary care practices would benefit from assessing their organizational context and taking steps to address it prior to or in a phased approach with mental health service implementation.

Data Linkage Strategies to Advance Youth Suicide Prevention: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop.

BACKGROUND: Linking national, state, and community data systems to data from prevention programs could allow for longer-term assessment of outcomes and evaluation of interventions to prevent suicide. PURPOSE: To identify and describe data systems that can be linked to data from prevention studies to advance youth suicide prevention research. DATA SOURCES: A systematic review, an environmental scan, and a targeted search were conducted to identify prevention studies and potentially linkable external data systems with suicide outcomes from January 1990 through December 2015. STUDY SELECTION: Studies and data systems had to be U.S.-based and include persons aged 25 years or younger. Data systems also had to include data on suicide, suicide attempt, or suicidal ideation. DATA EXTRACTION: Information about participants, intervention type, suicide outcomes, primary analytic method used for linkage, statistical approach, analyses performed, and characteristics of data systems was abstracted by 2 reviewers. DATA SYNTHESIS: Of 47 studies (described in 59 articles) identified in the systematic review, only 6 were already linked to data systems. A total of 153 unique and potentially linkable data systems were identified, but only 66 were classified as "fairly accessible" and had data dictionaries available. Of the data systems identified, 19% were established primarily for research, 11% for clinical care or operations, 29% for administrative services (such as billing), and 52% for surveillance. About one third (37%) provided national data, 12% provided regional data, 63% provided state data, and 41% provided data below the state level (some provided coverage for >1 geographic unit). LIMITATION: Only U.S.-based studies published in English were included. CONCLUSION: There is untapped potential to evaluate and enhance suicide prevention efforts by linking suicide prevention data with existing data systems. However, sparse availability of data dictionaries and lack of adherence to standard data elements limit this potential. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Pediatric Use of Emergency Medical Services: The Role of Chronic Illnesses and Behavioral Health Problems.

OBJECTIVE: The increasing use of prehospital emergency medical services (EMS) and its contribution to rising emergency department use and healthcare costs point to the need for better understanding factors associated with EMS use to inform preventive interventions. Understanding patient factors associated with pediatric use of EMS will inform pediatric-specific intervention. We examined pediatric patient demographic and health factors associated with one-time and repeat use of EMS. METHODS: We reviewed data from Baltimore City Fire Department EMS patient records over a 23-month period (2008-10) for patients under 21 years of age (n = 24,760). Repeat use was defined as involvement in more than one EMS incident during the observation period. Analyses compared demographics of EMS users to the city population and demographics and health problems of repeat and one-time EMS users. Health comparisons were conducted at the patient and incident levels of analysis. RESULTS: Repeat users (n = 1,931) accounted for 9.0% of pediatric users and 20.8% of pediatric incidents, and were over-represented among the 18-20 year age group and among females. While trauma accounted for approximately one-quarter of incidents, repeat versus one-time users had a lower proportion of trauma-related incidents (7.2% vs. 26.7%) and higher proportion of medical-related incidents (92.6% vs. 71.4%), including higher proportions of incidents related to asthma, seizures, and obstetric/gynecologic issues. In patient-level analysis, based on provider or patient reports, greater proportions of repeat compared to one-time users had asthma, behavioral health problems (mental, conduct and substance use problems), seizures, and diabetes. CONCLUSIONS: Chronic somatic conditions and behavioral health problems appear to contribute to a large proportion of the repeat pediatric use of this EMS system. Interventions may be needed to engage repeat users in primary care and behavioral health services, to train EMS providers on the recognition and management of behavioral health emergencies, and to improve family care and self-management of pediatric asthma and other chronic conditions.

Using vignettes to assess contributions to the work of addressing child mental health problems in primary care.

BACKGROUND: To further efforts to integrate mental health and primary care, this study develops a novel approach to quantifying the amount and sources of work involved in shifting care for common mental health problems to pediatric primary care providers. METHODS: Email/web-based survey of a convenience sample (n = 58) of Maryland pediatricians (77% female, 58% at their site 10 or more years; 44% in private practice, 52 % urban, 48 % practicing with a co-located mental health provider). Participants were asked to review 11 vignettes, which described primary care management of child/youth mental health problems, and rate them on an integer-based ordinal scale for the overall amount of work involved compared to a 12th reference vignette describing an uncomplicated case of ADHD. Respondents were also asked to indicate factors (time, effort, stress) accounting for their ratings. Vignettes presented combinations of three diagnoses (ADHD, anxiety, and depression) and three factors (medical co-morbidity, psychiatric co-morbidity, and difficult families) reported to complicate mental health care. The reference case was pre-assigned a work value of 2. Estimates of the relationship of diagnosis and complicating factors with workload were obtained using linear regression, with random effects at the respondent level. RESULTS: The 58 pediatricians gave 593 vignette responses. Depression was associated with a 1.09 unit (about 50%) increase in work (95% CL .94, 1.25), while anxiety did not differ significantly from the reference case of uncomplicated ADHD (p = .28). Although all three complicating factors increased work ratings compared with the reference case, family complexity and psychiatric co-morbidity did so the most (.87 and 1.07 units, respectively, P < .001) while medical co-morbidity increased it the least (.44 units, p < .001). Factors most strongly associated with increased overall work were physician time, physician mental effort, and stress; those least strongly associated were staff time, physician physical effort, and malpractice risk. Pediatricians working with co-located mental health providers gave higher work ratings than did those without co-located staff. CONCLUSIONS: Both diagnosis and cross-diagnosis complicating factors contribute to the work involved in providing mental health services in primary care. Vignette studies may facilitate understanding which mental health services can be most readily incorporated into primary care as it is presently structured and help guide the design of training programs and other implementation strategies.

Grand challenges: Improving HIV treatment outcomes by integrating interventions for co-morbid mental illness.

In the fourth article of a five-part series providing a global perspective on integrating mental health, Sylvia Kaaya and colleagues discuss the importance of integrating mental health interventions into HIV prevention and treatment platforms.

Effect of General Practitioner Training in a Collaborative Child Mental Health Care Program on Children's Mental Health Outcomes in a Low-Resource Setting: A Cluster Randomized Trial.

Importance: Integrated care for children is rarely studied, especially in low- and middle-income countries, where generalists often provide mental health care. Objectives: To explore the effect of adding a child and youth component to an existing adult collaborative care program on mental health outcomes and receipt of care. Design, Setting, and Participants: This cluster randomized trial was conducted within an adult collaborative care program in Tehran, Iran. General practitioners (GPs), their 5- to 15-year-old patients, and patients' parents were included. Children and youths coming for routine medical visits who scored greater than the cutoff on the Strengths and Difficulties Questionnaire (SDQ) were followed up for 6 months. The study was conducted from May 2018 to October 2019, and analysis was conducted from March 2020 to August 2021. Interventions: GPs were randomized to either a 2.5-day training on managing common child mental health problems (intervention) or refresher training on identification and referral (control). Main Outcomes and Measures: Primary outcome was change in SDQ total problems score; secondary outcomes included discussion of psychosocial issues by the GPs and receipt of mental health care during the follow-up period. Results: Overall, 49 GPs cared for 389 children who scored greater than the cutoff on the SDQ (216 children in intervention group, 173 in control group). Patients' mean (SD) age was 8.9 (2.9) years (range, 5 to 15 years), and 182 (47%) were female patients. At 6 months, children in the intervention group had greater odds of receiving mental health care during the study (odds ratio [OR], 3.0; 95% CI, 1.1 to 7.7), parents were more likely to report that intervention GPs had discussed parent (OR, 2.1; 95% Cl, 1.1 to 3.8) and child (OR, 2.0; 95% Cl, 0.9 to 4.8) psychosocial issues, and intervention GPs were more likely to say they had provided counseling (OR, 1.8; 95% Cl, 1.02 to 3.3). However, there was no greater improvement in SDQ scores among children seen by intervention vs control GPs. Adjusted for clustering within GP, the variables used for balanced allocation (practice size, practice ownership, and study wave), and the other variables associated with change in SDQ scores over time, there was not a significant time-treatment interaction at either the 3- or 6-month follow-up points (linear combination of coefficients for intervention, 0.57 [95% CI, -1.07 to 2.22] and -0.08 [95%CI, -1.76 to 1.56], respectively). In a subgroup of GPs with practices composed of 50% or more children, children seen by intervention GPs improved to a significantly greater extent (-3.6 points; 95% CI, -6.7 to -0.46 points; effect size d = 0.66; 95% CI, 0.30 to 1.01) compared with those seen by control GPs. Conclusions and Relevance: In this cluster randomized trial, GP training on managing common child mental health problems did not demonstrate greater improvement in child SDQ scores. Child mental health training for GPs in collaborative care can improve children's access to mental health care, but prior experience working with children and their families may be required for GPs to use a brief training in a way that improves child outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT03144739.

Youth Mental Health Screening and Linkage to Care.

One Mind, in partnership with Meadows Mental Health Policy Institute, convened several virtual meetings of mental health researchers, clinicians, and other stakeholders in 2020 to identify first steps toward creating an initiative for early screening and linkage to care for youths (individuals in early adolescence through early adulthood, ages 10-24 years) with mental health difficulties, including serious mental illness, in the United States. This article synthesizes and builds on discussions from those meetings by outlining and recommending potential steps and considerations for the development and integration of a novel measurement-based screening process in youth-facing school and medical settings to increase early identification of mental health needs and linkage to evidence-based care. Meeting attendees agreed on an initiative incorporating a staged assessment process that includes a first-stage brief screener for several domains of psychopathology. Individuals who meet threshold criteria on the first-stage screener would then complete an interview, a second-stage in-depth screening, or both. Screening must be followed by recommendations and linkage to an appropriate level of evidence-based care based on acuity of symptoms endorsed during the staged assessment. Meeting attendees proposed steps and discussed additional considerations for creating the first nationwide initiative for screening and linkage to care, an initiative that could transform access of youths to mental health screening and care.

Rethinking the mental health treatment skills of primary care staff: a framework for training and research.

Health care reforms may offer several opportunities to build the mental health treatment capacity of primary care. Capitalizing on these opportunities requires identifying the types of clinical skills that the primary care team requires to deliver mental health care. This paper proposes a framework that describes mental health skills for primary care receptionists, medical assistants, nurses, nurse practitioners, and physicians. These skills are organized on three levels: cross-cutting skills to build therapeutic alliance; broad-based, brief interventions for major clusters of mental health symptoms; and evidence-based interventions for diagnosis specific disorders. This framework is intended to help inform future mental health training in primary care and catalyze research that examines the impact of such training.

Technology-assisted task-sharing to bridge the treatment gap for childhood developmental disorders in rural Pakistan: an implementation science case study.

BACKGROUND: As in many low-income countries, the treatment gap for developmental disorders in Pakistan is nearly 100%. The World Health Organization (WHO) has developed the mental Health Gap Intervention guide (mhGAP-IG) to train non-specialists in the delivery of evidence-based mental health interventions in low-resource settings. However, a key challenge to scale-up of non-specialist-delivered interventions is designing training programs that promote fidelity at scale in low-resource settings. In this case study, we report the experience of using a tablet device-based application to train non-specialist, female family volunteers in leading a group parent skills training program, culturally adapted from the mhGAP-IG, with fidelity at scale in rural community settings of Pakistan. METHODS: The implementation evaluation was conducted as a part of the mhGAP-IG implementation in the pilot sub-district of Gujar Khan. Family volunteers used a technology-assisted approach to deliver the parent skills training in 15 rural Union Councils (UCs). We used the Proctor and RE-AIM frameworks in a mixed-methods design to evaluate the volunteers' competency and fidelity to the intervention. The outcome was measured with the ENhancing Assessment of Common Therapeutic factors (ENACT), during training and program implementation. Data on other implementation outcomes including intervention dosage, acceptability, feasibility, appropriateness, and reach was collected from program trainers, family volunteers, and caregivers of children 6 months post-program implementation. Qualitative and quantitative data were analyzed using the framework and descriptive analysis, respectively. RESULTS: We trained 36 volunteers in delivering the program using technology. All volunteers were female with a mean age of 39 (± 4.38) years. The volunteers delivered the program to 270 caregivers in group sessions with good fidelity (scored 2.5 out of 4 on each domain of the fidelity measure). More than 85% of the caregivers attended 6 or more of 9 sessions. Quantitative analysis showed high levels of acceptability, feasibility, appropriateness, and reach of the program. Qualitative results indicated that the use of tablet device-based applications, and the cultural appropriateness of the adapted intervention content, contributed to the successful implementation of the program. However, barriers faced by family volunteers like community norms and family commitments potentially limited their mobility to deliver the program and impacted the program' reach. CONCLUSIONS: Technology can be used to train non-specialist family volunteers in delivering evidence-based intervention at scale with fidelity in low-resource settings of Pakistan. However, cultural and gender norms should be considered while involving females as volunteer lay health workers for the implementation of mental health programs in low-resource settings.

Application of the Spanish-Language Consultation and Relational Empathy (CARE) Measure to Assess Patient-Centered Care Among Latino Populations.

INTRODUCTION: Reliable and valid measures are needed to assess the patient-centeredness of clinical care among Latino populations. METHODS: We translated the Consultation and Relational Empathy (CARE) measure from English to Spanish and assessed its psychometric properties using data from 349 Latino parents/guardians visiting a pediatric clinic. Using confirmatory factor analysis, we examined the psychometric properties of the Spanish CARE measure. RESULTS: Internal reliability of the Spanish CARE measure was high (Omega coefficient = 0.95). Similar to the English-language CARE measure, factor analysis of the Spanish CARE measure yielded a single domain of patient-centeredness with high item loadings (factor loadings range from 0.79 to 0.96). CONCLUSION: This preliminary analysis supports the reliability and validity of the Spanish version of the CARE measure among Latinos in pediatric care settings. With further testing, the Spanish CARE measure may be a useful tool for tracking and improving the health care delivered to Latino populations.

Addressing Psychosocial Topics in Group Well-Child Care: A Multi-Method Study With Immigrant Latino Families.

OBJECTIVE: Group Well-Child Care (GWCC) has been described as providing an opportunity to enhance well-being for vulnerable families experiencing psychosocial challenges. We sought to explore benefits and challenges to the identification and management of psychosocial concerns in Group Well-Child Care (GWCC) with immigrant Latino families. METHODS: We conducted a case study of GWCC at an urban academic general pediatric clinic serving predominantly Limited English Proficiency Latino families, combining visit observations, interviews, and surveys with Spanish-speaking mothers participating in GWCC, and interviews with providers delivering GWCC. We used an adapted framework approach to qualitative data analysis. RESULTS: A total of 42 mothers and 9 providers participated in the study; a purposefully selected subset of 17 mothers was interviewed, all providers were interviewed. Mothers and providers identified both benefits and drawbacks to the structure and care processes in GWCC. The longer total visit time facilitated screening and education around psychosocial topics such as postpartum depression but made participation challenging for some families. Providers expressed concerns about the effects of shorter one-on-one time on rapport-building; most mothers did not express similar concerns. Mothers valued the opportunity to make social connections and to learn from the lived experiences of their peers. Discussions about psychosocial topics were seen as valuable but required careful navigation in the group setting, especially when fathers were present. CONCLUSIONS: Participants identified unique benefits and barriers to addressing psychosocial topics in GWCC. Future research should explore the effects of GWCC on psychosocial disclosures and examine ways to enhance benefits while addressing the challenges identified.

Ineligibility for and Refusal to Participate in Randomized Controlled Trials That Have Studied Impact on Suicide-Related Outcomes in the United States: A Meta-Analysis.

Objective: Ineligibility for and refusal to participate in randomized controlled trials (RCTs) can potentially lead to unrepresentative study samples and limited generalizability of findings. We examined the rates of exclusion and refusal in RCTs that have studied impact on suicide-related outcomes in the US.Data Sources: PubMed, the Cochrane Library, the Campbell Collaboration Library of Systematic Reviews, CINAHL, PsycINFO, and Education Resources Information Center were searched from January 1990 to May 2020 using the terms (suicide prevention) AND (clinical trial).Study Selection: Of 8,403 studies retrieved, 36 RCTs assessing effectiveness on suicide-related outcomes in youth (≤ 25 years old) conducted in the US were included.Data Extraction: Study-level data were extracted by 2 independent investigators for a random-effects meta-analysis and meta-regression.Results: The study participants (N = 13,264) had a mean (SD) age of 14.87 (1.58) years and were 50% male, 23% African American, and 24% Hispanic. The exclusion rate was 36.4%, while the refusal rate was 25.5%. The exclusion rate was significantly higher in the studies excluding individuals not exceeding specified cutoff points of suicide screening tools (51.2%; adjusted linear coefficient [ß] = 1.30, standard error [SE] = 0.15; P = .041) and individuals not meeting the age or school grade criterion (45.9%; ß = 1.37, SE = 0.13; P = .005).Conclusions: The rates of exclusion and refusal in youth prevention interventions studying impact on suicide-related outcomes were not as high compared to the rates found in other mental and behavioral interventions. While there was strong racial/ethnic group representation in RCTs examining youth suicide-related outcomes, suicide severity and age limited eligibility.

Efficacy and cost-effectiveness of task-shared care for people with severe mental disorders in Ethiopia (TaSCS): a single-blind, randomised, controlled, phase 3 non-inferiority trial.

BACKGROUND: There have been no trials of task-shared care (TSC) using WHO's mental health Gap Action Programme for people with severe mental disorders (psychosis or affective disorder) in low-income or middle-income countries. We aimed to evaluate the efficacy and cost-effectiveness of TSC compared with enhanced specialist mental health care in rural Ethiopia. METHODS: In this single-blind, phase 3, randomised, controlled, non-inferiority trial, participants had a confirmed diagnosis of a severe mental disorder, recruited from either the community or a local outpatient psychiatric clinic. The intervention was TSC, delivered by supervised, non-physician primary health care workers trained in the mental health Gap Action Programme and working with community health workers. The active comparison group was outpatient psychiatric nurse care augmented with community lay workers (PSY). Our primary endpoint was whether TSC would be non-inferior to PSY at 12 months for the primary outcome of clinical symptom severity using the Brief Psychiatric Rating Scale, Expanded version (BPRS-E; non-inferiority margin of 6 points). Randomisation was stratified by health facility using random permuted blocks. Independent clinicians allocated groups using sealed envelopes with concealment and outcome assessors and investigators were masked. We analysed the primary outcome in the modified intention-to-treat group and safety in the per-protocol group. This trial is registered with ClinicalTrials.gov, number NCT02308956. FINDINGS: We recruited participants between March 13, 2015 and May 21, 2016. We randomly assigned 329 participants (111 female and 218 male) who were aged 25-72 years and were predominantly of Gurage (198 [60%]), Silte (58 [18%]), and Mareko (53 [16%]) ethnicity. Five participants were found to be ineligible after randomisation, giving a modified intention-to-treat sample of 324. Of these, 12-month assessments were completed in 155 (98%) of 158 in the TSC group and in 158 (95%) of 166 in the PSY group. For the primary outcome, there was no evidence of inferiority of TSC compared with PSY. The mean BPRS-E score was 27·7 (SD 4·7) for TSC and 27·8 (SD 4·6) for PSY, with an adjusted mean difference of 0·06 (90% CI -0·80 to 0·89). Per-protocol analyses (n=291) were similar. There were 47 serious adverse events (18 in the TSC group, 29 in the PSY group), affecting 28 participants. These included 17 episodes of perpetrated violence and seven episodes of violent victimisation leading to injury, ten suicide attempts, six hospital admissions for physical health conditions, four psychiatric admissions, and three deaths (one in the TSC group, two in the PSY group). The incremental cost-effectiveness ratio for TSC indicated lower cost of -US$299·82 (95% CI -454·95 to -144·69) per unit increase in BPRS-E scores from a health care sector perspective at 12 months. INTERPRETATION: WHO's mental health Gap Action Programme for people with severe mental disorders is as cost-effective as existing specialist models of care and can be implemented effectively and safely by supervised non-specialists in resource-poor settings. FUNDING: US National Institute of Mental Health.