The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled treatment trial with an embedded stepped-wedge cluster randomized controlled recruitment trial
Authors: Parikh Rachana , Michelson Daniel , Malik Kanika , Shinde Sachin , Weiss Helen A. , Hoogendoorn Adriaan , Ruwaard Jeroen , Krishna Madhuri , Sharma Rhea , Bhat Bhargav , Sahu Rooplata , Mathur Sonal , Sudhir Paulomi , King Michael B , Cuijpers Pim , Chorpita Bruce , Fairburn Christopher G , Patel Vikram 
Published: December 2018

Abstract
Background
Conduct, anxiety and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention to improve mental health symptoms and recovery rates for school-going adolescents in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial.
Methods
We will conduct a two-arm individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated impact. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported impact of mental health difficulties, perceived stress, mental wellbeing and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. Parallel process evaluation, including estimations of the costs of delivering the interventions, will be conducted.
An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added impact of a classroom-based sensitization intervention over school-level recruitment sensitization activities on the primary outcome of referral rate (number of referred students as a proportion of the total sampling frame in each arm). Secondary outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms across the arms. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unbinding.
Discussion
Both trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for adolescents.
Trial registration: Both trials are registered prospectively with the National Institute of Health registry (www.clinicaltrials.gov, registration numbers NCT03633916 and NCT03630471)
Keywords: mental health, problem-solving, psychological treatment, stepped-wedge trial, adolescents, schools, randomized controlled trial, low- and middle-income countries, India.