Adolescents’ Resilience and Treatment Needs for Mental Health in Indian Slums
- Conditions
- Childhood disorder of social functioning, unspecified,
- Registration Number
- CTRI/2022/02/040307
- Lead Sponsor
- The George Institute For Global Health
- Brief Summary
**Background:**
Adolescents are vulnerable to common mental disorders(CMDs) which are a leading cause of death and disability for this group, inIndia.There are around 250 million adolescents in India.Depression and self-harm account for a major share of the **burden of deathand disability in this age group.**A study from rural Indiafound that suicide rates amongst adolescents are amongst the highest in theworld (148/100,000 and 58/100,000 for females and males, respectively). Theintervention being tested involves an anti-stigma campaign and an electronicdecision support system (EDSS) platform that allows for identification,diagnosis and treatment of CMD by doctors.
**Aim and Hypotheses**
The study aims to test clinical effectiveness andimplementation strategies to identify and reduce depression and suicide riskamong adolescents living in urban slums. We hypothesise that:
1. a community-based anti-stigma campaignwill lead to significant improvements in community behaviours towardadolescents with common mental disorders; and
2. a mobile device-baseddecision support system will improve the treatment of adolescents at high riskof CMDs (which is defined as stress, depression and increased risk ofself-harm/suicide for this project) and lead to higher remission rates fromdepression and reduced suicide risk.
**Study Design**
There are two phasesto the study.
**(1)** ***Optimisationof anti-stigma and mhealth intervention:*** –
a. Anti-stigmacomponent: System level interventions that reduce stigma, and upskill primaryhealth care workers, including doctors to identify and treat people with mentaldisorders by providing training and decision support tools, will be used toimprove mental health of adolescents.
b. mHealthcomponent: SMART Mental Health intervention 17 will be adaptedfor adolescents (10-19 years) living in urban slums, in Vijayawada and Delhi,to determine whether this strategy will increase remission rates for adolescentswith depression, other significant emotional or medically unexplainedcomplaints, and increased risk of self-harm/ suicide. Previous experienceof using mHealth and task sharing between physicians and non-physician healthworkers (NPHWs), will be expanded to adolescents in slums. Community women volunteers would be chosen from the slumsand would have similar education level as Accredited Social Health Activists(ASHAs). They will be trained on basic knowledge about mental health, stigmaand care of individuals with stress, depression, increased suicide risk.
**(2)** ***Effectivenesstesting***– A cluster randomised trial with slum clusters as theunit of randomisation. The trial will test clinical effectiveness andimplementation strategies across two geographical locations - Delhi and AndhraPradesh in India. About 69600 adolescents from both sites will be screened todevelop two cohorts of adolescents: those who are at high risk of CMDs andthose at low risk. Both cohorts will provide data on the stigma reductionprogramme and facilitate understanding of the impact of the campaign on thoseat high risk of CMD versus those not at high risk. Data from the high-riskcohort will provide information on the effect of the mHealth programme over aperiod of 12 months. A detailed process and economic evaluation of the trialwill be conducted. For participants in the intervention arm, the mHealth systemwill capture health services usage using analytic data to assess interventionfidelity. This will be followed by data analyses and disseminationthrough public engagement meetings and policy symposia.
**Study Duration:** The total study duration is three years:
Phase 1 (intervention optimization and regulatoryapprovals) – 1-12 months
Phase 2 (cRCT and post-trial assessment) - 13-36 months
**Baseline Data collection:**
All individuals included in both the high-risk and arandomised cohort of low risk adolescents will have a detailed assessment byinterviewers where they will be asked questions about their socio-demographicand health characteristics, mental health awareness and experience ofstigma/discrimination by family,community, friends,peers etc, social support,stressors, treatment history, past history, alcohol and substance use, andinterpersonal violence
**Randomisation:**
Following baseline data collection, randomisation will be conducted at thelevel of the ward/block. Allocation of ward/block level in a 1:1 ratio tointervention or control will use a central allocation sequence and will bestratified by geographic region and number of wards/blocks. The wards/blocksselected under each intervention and control arms will be non-contiguous toavoid contamination. Random allocation forward/blocks will be performedusing SAS enterprise guide 7.1 or later version by PROC plan procedure.
**Interventions:**
The core components of the intervention will be:
(1) an anti-stigmacampaign to improve community behaviours toward adolescents with CMDs; and
(2) implementation ofthe mobile device-based decision support system to improve the treatment ofadolescents at high risk of CMDs and intended to lead to higher remission ratesfrom depression and reduced suicide risk.
**Outcomes:**
**Anti-stigma component (combinedhigh and low risk cohorts):**
**Primary:**
**1.** Changein mean behaviour scores at the end of the trial using the KAB scale
**Secondary**
1. Change in mean knowledge and attitude scores and changein stigma perceptions of adolescents as assessed by Barriers to Access to CareEvaluation- Treatment Stigma (BACE – TS) Subscale
2. Change from baseline in mean stigma scores across bothhigh and low risk cohorts
**2. mHealth component (high riskcohort)**
**Primary**
1. Proportion of high-risk achieving remission(defined as all of the following: PHQ-9 <5, and suicide risk score<2) at end of trial (12 months after randomisation).
**Secondary**
1. Standardised meandifference in PHQ-9 scores at end of trial
2. Proportion at high risk of CMDs(stress, depression and increased risk of suicide) who have visited a doctor atleast once between randomization and the end of the trial.
**Sample size considerations**
***Inthe combined high-risk and non-high-risk population:***Assuming aconservative ICC of 0.1 (0.01 in our pilot and 0.04 in similar studies) 6,15,20 % loss to follow-up and a 2-sided significance level of 0.05, 60 clustersand a mean cluster size of 66 per cluster (33 high-risk and 33 non-high-risk)will provide more than 90% power to detect a standardised mean difference of0.3 in mean behaviour scores between the intervention and control arms at 12months. Assuming baseline mean behaviour scores of 2 (SD 1) and a 20% improvementin the control arm based on pilot and published data,6 this corresponds to12-month behaviour scores of 1.6 (20% improvement) and 1.3 (35% improvement) inthe control and intervention arms respectively. This sample size also provides80% power to detect differences of effect size of 0.5 for subgroup analysesconsidering half of the numbers belong to the high risk and low risk groups.The individual samples for high-risk and low risk allows us to measure changesin the behavioural score separately across both these groups.
***For people with or at high riskof CMDs:*** Assuming a 50% remissionrate in the control arm at 12 months based on published data, and30 clusters per intervention arm, at least 27 subjects per cluster are neededto detect a 15% absolute improvement in the intervention arm (65% interventionvs 50% control) at 12 months with 90% power. This assumes a 2-sidedsignificance level of 0.05 and an intra-class correlation coefficient (ICC) of0.1 based on pilot dataand recent (unpublished) analyses. Forsecondary outcomes, this sample size will also provide 86% power to detect astandardised mean difference of 0.3 in PHQ-9 scores considering an ICC of 0.1.The hypothesised effect size is consistent to that published in a recent Indianstudy on provision of mental health services using lay health workers incommunity settings.
To account for up to 20% of participants lost tofollow-up, we will aim to enrol at least 33 participants per cluster for atotal sample size of 1980 adolescents (60 clusters × 33 adolescents). Weanticipate a prevalence of approximately 3% and will therefore aim to screenabout 1,100 adolescents in each cluster. Further assuming that 5% of eligibleadolescents will refuse to participate, we aim to screen 1,160 adolescents ineach cluster i.e. a total of 69,600 adolescents (60 clusters × 1,160adolescents). The sample has more than 80% power at 2α = 0.05 to assess sex disaggregatedestimates for both the primary outcomes, assuming equal proportion of male andfemale in the high-risk and low risk cohorts. Research suggests that amongadolescent’s depression is equally distributed in males and females.
**Data collection**
Assuming a prevalence of 3% of adolescents with CMDs(based on published and Andhra Pradesh data), we anticipate that around 34800adolescents per region will need to be screened to achieve the required samplesize. Both ‘high-risk’ and ‘low-risk’ cohorts will be re-interviewed at 3, 6,12 months. Outcome data will be collected by trained interviewers, blinded tointervention allocation. Blinding will be done by recruiting staff who will betrained to collect only this data and who has not been involved in any of theprevious phase of the study. Participants will be interviewed for approximatelyone hour in their house and the same questionnaires will be administered atfollow-up, including questions on mental health services use and quality oflife.
Quantitative data on stigma perceptions related to mentalhealth and depression/anxiety will be collected prior to the randomisation(Time 0) and then subsequently at 3, 6, 12 months of the intervention.
**Time - 0 month (pre-randomisation):** The names of those at high-risk will be shared withtrained interviewers who will then administer a detailed questionnaire thatwill enquire about sociodemographic characteristics, treatment history, pasthistory of any mental illness, family history of any mental illness, socialsupport from friends and families, stressful events experienced in the last oneyear, history of any comorbid major physical illnesses.
Time**– 3, 6, 12 months (intervention phase):** Data will be collected fromall high-risk and a random sample of low risk adolescents across all thewards/blocks by trained interviewers. Questionnaires will administer the PHQ9,KAB and BACE-TS at these time points.
**Process and Economic evaluation**
Processes will be monitored continuously throughout theintervention phase. A formal evaluation will be implemented using Michie’sbehaviour change theory as the over-arching framework to guide ourunderstanding of the intervention implementation and impact. This theoryassesses the capability, opportunity and motivation of adolescents, communitywomen volunteers/NPHWs and doctors to engage with the intervention. We willtake a case study approach in which a purposive sample of clusters will beselected. Qualitative data about the experiences of the community participants,UHC worker, doctors, and other key stakeholders will be gathered through focusgroups and in-depth interviews. For participants in the mHealth interventionarm, the mHealth system will capture health services usage analytic data toassess intervention fidelity. A mixed methods analysis will be conducted likethe approach taken in earlier trials and following MRC guidelines. Atrial-based and a modelled evaluation of long-term costs and outcomes will beconducted from a health system perspective.
**Data Analyses**
Suitable descriptive and analytic statistics will be conducted,and models will be developed to understand factors associated with the outcomevariables. Qualitative data will be analysed using appropriate techniques toidentify key concepts
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 69600
- All consenting adolescents in the age group of 10 – 19 years will be eligible for screening for CMDs to identify both a high risk and low risk cohort.
- Informed consent will be sought from all adult participants, and assent sought from minor participants following consent from their guardians.
- To be eligible for the high risk cohort participants must have at least one of the following: 1.High risk of depression based on a Patient Health Questionnaire-9 item (PHQ9) score ≥ 10 2.Positive response ( score ≥2) to the suicide risk question on the PHQ-9.
1.Participants with severe ill-health that would prevent regular follow-up 2.Adolescents or their guardians do not provide informed written consent 3.Participants who are temporary residents of the slums.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To change the mean behaviour scores at the end of the trial using the KAB scale 12 months 2. To assess the proportion of high risk achieving remission at end of trial 12 months
- Secondary Outcome Measures
Name Time Method 1.To change mean knowledge and attitude scores and change stigma perceptions of adolescents as assessed by BACE – TS Subscale 2.To change baseline mean stigma scores across both high and low risk cohorts
Trial Locations
- Locations (1)
George Institute For Global Health
🇮🇳Krishna, ANDHRA PRADESH, India
George Institute For Global Health🇮🇳Krishna, ANDHRA PRADESH, IndiaDr Pallab MaulikPrincipal investigator01141588091pmaulik@georgeinstitute.org.in