NCT03630471: PRIDE

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

Completed NA Last updated 21 May 2019

What this trial tests

NA trial testing PRIDE 'Step 1' problem-solving intervention in Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) in 250 participants. Completed in 28 February 2019.

Timeline

20 August 2018

Primary endpoint
20 January 2019

28 February 2019

Quick facts

Lead sponsor	Sangath
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	250
Start date	20 August 2018
Primary completion	20 January 2019
Estimated completion	28 February 2019
Sites	1 location across India

Drugs / interventions tested

• PRIDE 'Step 1' problem-solving intervention
• Enhanced usual care

Conditions studied

• Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) — all drugs for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse) →

Sponsor

Sangath

Who can join

Adults 13 to 20, any sex, with Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Primary-level worker interventions for the care of people living with mental disorders and distress in low- and middle-income countries.
   van Ginneken N, Chin WY, Lim YC, Ussif A, et al · · 2021 · cited 89× · PMID 34352116 · DOI 10.1002/14651858.cd009149.pub3
2. Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial.
   Michelson D, Malik K, Parikh R, Weiss HA, et al · · 2020 · cited 69× · PMID 32585185 · DOI 10.1016/s2352-4642(20)30173-5
3. Effectiveness and costs associated with a lay counselor-delivered, brief problem-solving mental health intervention for adolescents in urban, low-income schools in India: 12-month outcomes of a randomized controlled trial.
   Malik K, Michelson D, Doyle AM, Weiss HA, et al · · 2021 · cited 18× · PMID 34582460 · DOI 10.1371/journal.pmed.1003778
4. 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 tria
   Parikh R, Michelson D, Malik K, Shinde S, et al · · 2019 · cited 14× · PMID 31533783 · DOI 10.1186/s13063-019-3573-3
5. Psychological interventions for psychosis in adolescents.
   Datta SS, Daruvala R, Kumar A. · · 2020 · cited 9× · PMID 32633858 · DOI 10.1002/14651858.cd009533.pub2