Effectiveness of a Problem-solving Intervention for Common Adolescent Mental Health Problems in India

NCT03630471 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2019-05-21

No results posted yet for this study

Summary

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 difficulties and associated impact. Participants will receive either a brief problem-solving intervention delivered by lay counsellors (intervention), or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health difficulties 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 difficulties 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.

Conditions

  • Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)

Interventions

BEHAVIORAL

PRIDE 'Step 1' problem-solving intervention

The PRIDE problem-solving intervention is one component of the PRIDE stepped care treatment architecture which comprises two sequential treatments of incremental intensity. 'Step 1' is a brief, first-line treatment. It is grounded in stress-coping theory, with a technical focus on practical problem-solving to modify developmentally salient stressors. Step 1 has been designed as a 'low-intensity' intervention requiring fewer resources than conventional psychological treatments. This is achieved through a relatively brief delivery schedule (up to 5 x 20-30-minute sessions spread over approximately 3 weeks) and limited requirement for specialists. The delivery agents are lay counsellors receiving a combination of specialist and peer supervision. The counsellors offer guidance sessions to support the learning and implementation of problem-solving and complementary coping skills. Illustrated booklets are used to support learning of problem-solving concepts and skills practice at home.

BEHAVIORAL

Enhanced usual care

There is no established mental health service provision in the collaborating schools. The control arm participants will receive an enhancement of this 'usual care' (essentially, no care) by having access to the same illustrated booklets used in the Intervention arm, albeit without any counsellor contact.

Sponsors & Collaborators

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER
  • London School of Hygiene and Tropical Medicine

    collaborator OTHER
  • Sangath

    lead OTHER

Principal Investigators

  • Vikram Patel, PhD · Harvard Medical School (HMS and HSDM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-20
Primary Completion
2019-01-20
Completion
2019-02-28

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03630471 on ClinicalTrials.gov