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 trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial

Rachana Parikh, Daniel Michelson, Kanika Malik, Sachin Shinde, Helen A Weiss, Adriaan Hoogendoorn, Jeroen Ruwaard, Madhuri Krishna, Rhea Sharma, Bhargav Bhat, Rooplata Sahu, Sonal Mathur, Paulomi Sudhir, Michael King, Pim Cuijpers, Bruce F Chorpita, Christopher G Fairburn, Vikram Patel, Rachana Parikh, Daniel Michelson, Kanika Malik, Sachin Shinde, Helen A Weiss, Adriaan Hoogendoorn, Jeroen Ruwaard, Madhuri Krishna, Rhea Sharma, Bhargav Bhat, Rooplata Sahu, Sonal Mathur, Paulomi Sudhir, Michael King, Pim Cuijpers, Bruce F Chorpita, Christopher G Fairburn, Vikram Patel

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 for school-going adolescents with common mental health problems 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/design: 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 distress/impairment. 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 distress/impairment, 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. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions. 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 effect of a classroom-based sensitization intervention over and above school-level sensitization activities on the primary outcome of referral rate into the host trial. Other 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 among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding.

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 common adolescent mental health problems.

Trial registration: Both trials are registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration numbers NCT03633916 and NCT03630471 , registered on 16th August, 2018 and 14th August, 2018 respectively).

Keywords: Adolescents; India; Low- and middle-income countries; Mental health; Problem-solving; Psychological intervention; Randomized controlled trial; Schools; Stepped-wedge trial.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Illustration showing implementation of the control and intervention conditions in the embedded recruitment trial. The white boxes indicate the group of classes in the control condition and the colored boxes indicate the group of classes in the intervention condition. *0 = control condition; 1 = intervention condition
Fig. 2
Fig. 2
CONSORT flowchart for the embedded recruitment trial. The white boxes indicate the group of classes in the control condition and the colored boxes indicate the group of classes in the intervention condition
Fig. 3
Fig. 3
CONSORT flowchart for the host trial
Fig. 4
Fig. 4
SPIRIT figure for the embedded recruitment trial
Fig. 5
Fig. 5
SPIRIT figure for the host trial

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