Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06017700
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-30
First Post:
2023-08-24
Brief Title:
School-based IPT-G for Adolescents With Depression in Nepal a Pilot Realist C-RCT
Sponsor:
Transcultural Psychosocial Organization Nepal
Organization:
Transcultural Psychosocial Organization Nepal
Study Overview
Official Title:
School-based Group Interpersonal Therapy for Adolescents With Depression in Nepal a Pilot Realist Cluster-randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAATHI-2
Brief Summary:
Globally a third of adolescents are at risk of depression with negative consequences for their health and development Most of the worlds adolescents live in low- and middle-income countries LMICs where access to treatment for depression is limited Psychological interventions are treatments that seek to change behaviours cognitions and feelings to improve mental health but few have been tested with adolescents in LMICs This study will use a cluster randomised controlled trial approach to test one such intervention interpersonal therapy IPT for adolescents in Chitwan district Nepal The current study will compare whether adolescents aged 13-18 with depression who receive group interpersonal therapy improve more than adolescents who receive information about local mental health services but no active intervention enhanced usual care Adolescents depressive symptoms will be assessed eight to ten weeks after IPT has finished using the Patient Health Questionnaire modified for adolescents PHQ-A We will also aim to assess the feasibility and acceptability of delivering group IPT in secondary schools in Chitwan Nepal In addition in this trial we aim to refine our hypotheses around why IPT works how and for whom and pilot the tools which will be used to answer these questions later in the full trial
Detailed Description:
Depression and anxiety are leading causes of disability adjusted life years among adolescents aged 10-19 and can lead to social and educational impairment substance misuse and suicide The treatment gap for adolescent mental disorders is large especially in low-and middle-income countries LMICs The WHO Mental Health Gap Action Programme outlines a role for psychological therapies in the treatment of child and adolescent emotional disorders such as depression and anxiety however there is an urgent need to adapt these for use in LMICs Between 2018 and 2020 our team including researchers and clinicians from TPO Nepal and Kings College London adapted IPT for adolescents with depression in Nepal Using an iterative mixed methods procedure we adapted the WHO group IPT manual for delivery by school nurses and lay people in government secondary schools We conducted an uncontrolled feasibility study of IPT with 62 adolescent boys and girls aged 13 to 19 in the mountainous district of Sindhupalchowk Adolescents attended 823 standard deviation 189 of group sessions Depression and functional impairment improved between baseline and follow-up at 8-10 weeks post IPT The Depression Self Rating Scale score decreased by 81 95 confidence interval 70-95 functional impairment decreased by 288 249-351
Building on this previous research we have designed a 4-stage 5-year programme of work The overall aim is to test the effectiveness and cost of scaling-up IPT in Nepal taking a realist evaluation approach where we will explore IPTs mechanisms of change and contextual factors that moderate its effects This involves using formative research to develop an intervention theory of change from which we formulate hypotheses about how intervention mechanisms might interact with context to produce outcomes context mechanism-outcome configurations CMOCs
According to this programme Stage 1 Formative Phase is already completed Currently we are applying for Stage 2 which is a pilot cluster randomized controlled trial CRCT-pilot of IPT for adolescent depression in Chitwan a district in the lowland region of Nepal As part of the current application we aim to 1 test the feasibility and acceptability of the trial protocols 2 pilot the qualitative and quantitative tools and 3 refine the theory of change hypotheses Building on it we will later apply for Stage 3 which will be a full cluster randomized controlled trial assessing the effectivenesscost-effectiveness of IPT CRCT-full and Stage 4 which will consist of testing the CMOs using quantitative data from the full trial
The study design is a parallel two-arm realist pilot cluster-randomised controlled trial The trial will be conducted in eight schools four intervention and four control We will assess participants in intervention and control arms at baseline week 0 after the second group session week 4 after the sixth group session week 8 at endline weeks 13-14 and at follow-up weeks 25-26 The acceptability of the intervention randomisation tools uptake utility of the intervention facilitators fidelity to the manual mental health outcomes and cost of design and delivery of the intervention will be assessed The intervention process data will be also collected This will include FGDs and interviews with adolescents and their parents facilitators nurses teachers and school principals to explore feasibility and acceptability of the intervention and study procedures
Building on this previous research we have designed a 4-stage 5-year programme of work The overall aim is to test the effectiveness and cost of scaling-up IPT in Nepal taking a realist evaluation approach where we will explore IPTs mechanisms of change and contextual factors that moderate its effects This involves using formative research to develop an intervention theory of change from which we formulate hypotheses about how intervention mechanisms might interact with context to produce outcomes context mechanism-outcome configurations CMOCs
According to this programme Stage 1 Formative Phase is already completed Currently we are applying for Stage 2 which is a pilot cluster randomized controlled trial CRCT-pilot of IPT for adolescent depression in Chitwan a district in the lowland region of Nepal As part of the current application we aim to 1 test the feasibility and acceptability of the trial protocols 2 pilot the qualitative and quantitative tools and 3 refine the theory of change hypotheses Building on it we will later apply for Stage 3 which will be a full cluster randomized controlled trial assessing the effectivenesscost-effectiveness of IPT CRCT-full and Stage 4 which will consist of testing the CMOs using quantitative data from the full trial
The study design is a parallel two-arm realist pilot cluster-randomised controlled trial The trial will be conducted in eight schools four intervention and four control We will assess participants in intervention and control arms at baseline week 0 after the second group session week 4 after the sixth group session week 8 at endline weeks 13-14 and at follow-up weeks 25-26 The acceptability of the intervention randomisation tools uptake utility of the intervention facilitators fidelity to the manual mental health outcomes and cost of design and delivery of the intervention will be assessed The intervention process data will be also collected This will include FGDs and interviews with adolescents and their parents facilitators nurses teachers and school principals to explore feasibility and acceptability of the intervention and study procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None