NCT04723277.

Study name	Efficacy of teacher‐delivered child mental healthcare in primary schools of India (TeaLeaF)
Methods	Study design: cluster‐RCT Country: India
Participants	Children in rural primary schools (class I‐IV) Inclusion criteria:  Schools: a. does not receive government aid (i.e. not subject to the rules and regulations of government or government‐aided schools; b. at least 3 full‐time classroom teachers on staff; c. annual student fees $180/11,500 Indian rupee (INR) or less. Teachers: a. employed at a participating school; b. primary teaching responsibility in the primary grade level; c. 18 years or older. Children: a. enrolled in class I‐IV; b. enrolled in the classroom of a participating teacher. Exclusion criteria: Schools: a. not located in the rural Darjeeling Himalayas (defined as the Mirik, Kurseong, and Darjeeling Sadar subdivisions of the Darjeeling District and outside the statutory towns of Darjeeling, Kurseon, and Mirik) Teachers: a. have been convicted and/or are under investigation for any child‐related misconduct or maltreatment Children: a. do not have a parent or guardian who can provide informed consent Stated purpose: to evaluate the efficacy of teacher‐delivered transdiagnostic mental healthcare for children in rural primary schools of India. Implementation process and context will also be examined.
Interventions	Intervention: Tealeaf: Mansik Swastha Tealeaf is a task‐shifting intervention in which teachers deliver transdiagnostic mental health care. Mental health challenges are understood through basic functional behaviour assessments, providing a framework for the analysis of observable behaviours. Teachers deliver care primarily through the incorporation of basic therapeutic interactions into classroom instruction time, supplemented by one‐on‐one interactions with the child and family. Control: Enhanced Usual Care (EUC) is a less intensive version of the Tealeaf intervention. The EUC service package has been designed to be the most intensive form of care that could be envisioned as viable in the study setting in the foreseeable future without a significant increase in resource investment.
Outcomes	Participants'outcomes of interest for this review Mental health symptoms (psychopathology) – Strengths and Difficulties Questionnaire Total Difficulties Score (SDQ) Economic outcomes Nil Time points: baseline, post‐intervention (8 months from baseline)
Starting date	1 January 2019
Contact information	Christina Cruz
Notes	Source of funding: not specified (only list of Sponsors and Collaborators) Prospective trial registration number: NCT04723277