Scalable Transdiagnostic Early Assessment of Mental health (STREAM): Study Protocol

Introduction: Early childhood development forms the foundations for functioning later in life. Thus, the ability to accurately monitor developmental trajectories is critical. However, such monitoring is complicated by reliance on time-intensive assessments which often necessitate administration by skilled professionals. This difficulty is exacerbated in low-resource settings where such professionals are predominantly concentrated in urban and often private clinics, rendering them inaccessible to a large portion of the population. This geographic and economic inaccessibility contributes to a significant 'detection gap' where many children who might benefit from additional support remain undetected. The Scalable Transdiagnostic Early Assessment of Mental Health (STREAM) project aims to bridge this gap by developing an open-source, scalable, tablet-based mobile platform administered by non-specialist workers to assess motor, social, and cognitive developmental status. The ultimate goal is to deploy STREAM through public health initiatives, maximising opportunities for effective early interventions. Methods and analysis: Four thousand children aged 0-6 years from Malawi (n=2000) and India (n=2000) will be enrolled and assessed using the STREAM platform. STREAM integrates three established developmental assessment tools measuring motor, social, and cognitive functioning using gamified tasks, observation checklists, parent-report, and audio-video recordings. Domain scores for motor, social, and cognitive functioning will be developed and assessed for their validity and reliability. These domain scores will then be used to construct age-adjusted developmental reference curves. Ethics and dissemination: The STREAM project has received ethical approval from local ethics review boards at each study site, is carried out in accordance with Good Clinical Practice (GCP) standards, and adheres to ethical guidelines presented in the 6th (2008) Declaration of Helsinki. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was supported by the Medical Research Council's (MRC) Global Challenges Research Fund (GCRF), project reference MR/S036423/1. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Sangath Institutional Review Board gave ethical approval for this work. All India Institute of Medical Sciences Ethics Committee gave ethical approval for this work. Indian Council of Medical Research - Health Ministry Screening Committee gave ethical approval for this work. College of Medicine Research and Ethics Committee of University of Malawi gave ethical approval for this work. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Not applicable