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72 active trials for Psychological Distress

Early Adolescent Skills for Emotions (EASE)-Pilot Cluster Randomized Controlled Trial (cRCT) in Public Schools of Rural Pakistan

Background: Emotional problems such as symptoms of depression, anxiety and psychosocial distress are the leading contributors to health burden among adolescents worldwide. There is an urgent need for evidence-based psychological interventions for young people, especially those living in adversity. WHO has developed Early Adolescent Skills for Emotions (EASE), a brief group psychological intervention delivered by non-specialist providers for young adolescents impaired by distress and exposed to adversity. We aim to evaluate the feasibility of delivering EASE for young adolescents living in public schools of rural Rawalpindi, Pakistan. Objectives: To evaluate the feasibility of delivering Early Adolescent Skills for Emotions (EASE) program to young adolescents and their caregivers in Rawalpindi, Pakistan to inform the design, including sample size estimation, for a full-scale adequately powered definitive cluster randomised controlled trial. Methods: A two arm, single blind, pilot cluster randomized controlled trial will be conducted with adolescents of both gender (aged 13-15 years) with high psychological distress, studying in grade 8 and 9th of middle and high public school in rural Rawalpindi. Schools will be the units of randomization. 8 public schools, stratified by gender, will be randomized into EASE plus Treatment as Usual (TAU) (n=4) and TAU alone (n=6). 60 young adolescents at-risk of psychosocial distress as assessed by Self-Reported-Pediatric Symptom Checklist (PSC), cut-off ?28 will be included in the study. No power calculations have been calculated for the present pilot trial; however, the sample will be adequate to inform the parameters of planned definitive cRCT. In the intervention arm, adolescents will receive 7-weekly group sessions and their caregivers will receive 3-weekly group sessions in public schools. Data on the number of outcomes will be collected at baseline, immediately and 3-months' post-intervention follow-up. The findings will inform the sample size required for a definitive trial. A detailed mixed-methods process evaluation will be conducted to identify areas of improvements prior to proceeding to a definitive cRCT. Discussion: The results of pilot trial will be used to inform the design of definitive cluster randomized controlled trial in government led scaled-up implementation of healthy school initiative in Rawalpindi district of Pakistan.

Start: February 2020
Validation of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) in Chile

The aim is to study the psychometric properties of the Spanish translation of the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), an instrument that measures psychological distress, in the Chilean population. To test internal consistency, test-retest stability, and discrimination, the CORE-OM is applied in three samples: a clinical sample (n=200) and two non-clinical samples (1. university students (n=400); and 2. general community (n=300)). Specific modalities of data collection are used for each sample. In the clinical sample, data is only collected at one time point. In the student and community samples, data is collected at two time points (i.e. baseline and retest). At baseline, participants are presented with the CORE-OM, the Outcome Questionnaire (OQ-45) and a set of sociodemographic and mental health service use items. After two weeks (i.e. retest) participants are presented with the CORE-OM plus an item about mental health service use in the last 30 days. Participants in the clinical sample complete the paper version of the questionnaire in the waiting room of the University Outpatient Clinic. The application modality in the non-clinical samples is mixed: students and general community participants complete paper or digital versions of the questionnaire in the classroom or community, respectively. The digital version of the questionnaire is in surveygizmo™ and can be accessed by clicking a Uniform Resource Locator (URL) embedded in an email/message, or by scanning a Quick Response (QR) code with a smartphone. Student and community participants are contacted via email after 2 weeks to respond the online retest questionnaire. The clinical sample is recruited at a University Outpatient Clinic in the Metropolitan Area of Santiago, which provides services to patients of low to medium income. Patients are approached by research assistants in the waiting area, before or after their psychotherapy/psychiatry session. Patients meeting inclusion criteria, and willing to participate, fill out an informed consent before responding the questionnaire. Questionnaire completion and responses to risk items are reviewed within 24 hours. Treating psychiatrists/psychologists are contacted via email when their patients respond "often" or "most of the time" to items signaling self-harm and thoughts of suicide (i.e. items 9, 16, 24 and 34 of the CORE-OM or item 8 of the OQ-45). The student sample is recruited in the classrooms of Pontificia Universidad Católica de Chile. A member of the research team presents the study and invites students to participate. Students agreeing to participate fill out an informed consent form before completing paper/digital versions of the questionnaire. Any student responding "often" or "most of the time" to items signaling self-harm and thoughts of suicide in the CORE-OM/OQ-45 receives an email from the Responsible Investigator with information about the University´s counseling services within 24 hours. The general community sample is recruited using a convenience sampling method (e.g. contacts of research team). As in the other samples, participants sign an informed consent before answering the questionnaire. Since the non-clinical samples serve to test stability, students/general community are asked to provide a valid email address in order to send them an email invitation after two weeks to complete the CORE-OM.

Start: January 2019