CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled
Drug / intervention
PRIDE 'Step 1' problem-solving intervention +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03630471
NCT03630471N/ACompleted

The Effectiveness of a Low-intensity, Lay Counsellor-delivered, Problem-solving Intervention for Common Mental Health Problems in School-going Adolescents in New Delhi, India: the PRIDE Study Protocol for a Randomized Controlled Trial

Sangath·interventional·Posted Aug 14, 2018·Updated May 21, 2019

In Brief

A clinical study evaluating PRIDE 'Step 1' problem-solving intervention and Enhanced usual care for Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse). Completed, enrolled 250 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartAug 20, 2018
Primary CompletionJan 20, 2019
Study CompletionFeb 28, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 7.9 years ago

Interventions

PRIDE 'Step 1' problem-solving interventionbehavioral

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.

Enhanced usual carebehavioral

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.