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
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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