Are government or non-governmental organization staff more effective in delivering frontline mental health services? Evidence from a cluster randomized controlled trial

Last registered on July 30, 2024
View Trial History

Pre-Trial

Trial Information

General Information

Title
Are government or non-governmental organization staff more effective in delivering frontline mental health services? Evidence from a cluster randomized controlled trial
RCT ID
AEARCTR-0013922
Initial registration date
July 01, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
July 08, 2024, 12:38 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Last updated
July 30, 2024, 7:34 AM EDT

Last updated is the most recent time when changes to the trial's registration were published.

Locations

Country
Ethiopia
Region
Tigray

Primary Investigator

Name
Melissa Hidrobo
Affiliation
IFPRI
Contact Primary Investigator

Other Primary Investigator(s)

PI Name
Jessica Leight
PI Affiliation
IFPRI
Contact Investigator
PI Name
Daniel Gilligan
PI Affiliation
IFPRI
Contact Investigator
PI Name
Negussie Deyessa
PI Affiliation
University of Rwanda
Contact Investigator
PI Name
Michael Mulford
PI Affiliation
World Vision
Contact Investigator
PI Name
Adiam Hailemicheal
PI Affiliation
World Bank
Contact Investigator
PI Name
Tigabu Getahun
PI Affiliation
EconInsight
Contact Investigator

Additional Trial Information

Status
On going
Start date
2024-01-15
End date
2025-12-31
Keywords
Health, Post-conflict
Additional Keywords
mental health, psychotherapy, randomized control trial, delivery platform
JEL code(s)
I1, H75
Secondary IDs
Large treatment gaps in mental health services exist, and to address the gap promising psychotherapy interventions delivered by non-specialists have been created and tested. However, questions remain as to how to scale-up these psychotherapy interventions, and in particular whether scaling-up through existing government health structures leads to similar results compared to non-governmental agencies. Using a randomized controlled trial (RCT) conducted in rural Ethiopia, this study will assess the effectiveness of a low-cost psychotherapy intervention, group Problem Management plus (gPM+), delivered in separate arms by stipended local facilitators (LFs) engaged by a non-govermental organization, or government-employed health extension workers (HEWs). The study will be evaluated through a baseline, one-month and 12 month follow-up surveys. Primary outcomes include mental health (depression, stress, anxiety, and post-traumatic stress) and child development measured at one month and 12 months post- program, as well as a range of secondary outcomes including economic outcomes (labor, savings, and food security), behavioral outcomes (alcohol abuse and intimate partner violence), cognitive and non-cognitive skills (General Self-Efficacy and forward digit span), social support, and childcare practices. In addition, to better understand mechanisms for any differential effects across delivery platforms, we will collect detailed data on knowledge, attitudes, and productivity of both HEWs and LFs.
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Large treatment gaps in mental health services exist, and to address the gap promising psychotherapy interventions delivered by non-specialists have been created and tested. However, questions remain as to how to scale-up these psychotherapy interventions, and in particular whether scaling-up through existing government health structures leads to similar results compared to non-governmental agencies. Using a randomized controlled trial (RCT) conducted in rural Ethiopia, this study will assess the effectiveness of a low-cost psychotherapy intervention, group Problem Management plus (gPM+), delivered in separate arms by stipended local facilitators (LFs) engaged by a non-govermental organization, or government-employed health extension workers (HEWs). The study will be evaluated through a baseline, one-month and 12 month follow-up surveys. Primary outcomes include mental health (depression, stress, anxiety, and post-traumatic stress) and child development measured at one month and 12 months post- program, as well as a range of secondary outcomes including economic outcomes (labor, savings, and food security), behavioral outcomes (alcohol abuse and intimate partner violence), cognitive and non-cognitive skills (General Self-Efficacy and forward digit span), social support, and childcare practices. In addition, to better understand mechanisms for any differential effects across delivery platforms, we will collect detailed data on knowledge, attitudes, and productivity of both HEWs and LFs.
External Link(s)

Registration Citation

Citation
Hidrobo, Melissa et al. 2024. "Are government or non-governmental organization staff more effective in delivering frontline mental health services? Evidence from a cluster randomized controlled trial ." AEA RCT Registry. July 30. https://doi.org/10.1257/rct.13922-1.2
Sponsors & Partners
Experimental Details

Interventions

Intervention(s)
The proposed study will test the effectiveness of two implementation models for delivering group Problem Management + (gPM+). gPM+ is an intervention developed by the World Health Organization in 2013 to address common mental health problems such as depression, stress, and anxiety. It involves problem management (PM) plus (+) selected behavioral strategies to address both psychological issues (e.g., stress, fear, feelings of helplessness) and, where possible, practical challenges. The first delivery model relies on health extension workers (HEWs), public employees already under government supervision who are trained and equipped by an NGO to deliver gPM+. The second entails local facilitators recruited for a short-term assignment and compensated hourly (i.e., not on a full-time basis) by an NGO.

Following the training and practicum period, each individual delivering gPM+ (HEW or LF) is assigned two gPM+ groups including up to eight individuals each, in order to deliver five 90-120 minute group sessions weekly over five weeks. The number of groups is consistent for all facilitators (whether HEWs or LFs), and the total anticipated workload for each facilitator is around 6—8 hours weekly for a period of five weeks (three to four hours per group). As the provision of mental health support is a responsibility for HEWs and thus within their scope, HEWs do not receive any additional compensation for engaging in this new activity. LFs are receiving a monthly payment for three months, compensating them for time committed to preparation, group facilitation, and follow-up during this period.
Intervention Start Date
2024-05-06
Intervention End Date
2024-07-01

Primary Outcomes

Primary Outcomes (end points)
Depressive symptoms as measured by the PHQ-9,
Stress as measured by the Perceived Stress Scale (PSS-10),
Post-traumatic stress as measured by the abbreviated PCL-C instrument,
Anxiety as measured by the General Anxiety Disorder 7 (GAD-7)
Child development as measured using the Strengths and Difficulties Questionnaire
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
The evaluation is conducted within four districts or woredas (Samre, Tsaeda Emba, Keletawelaelo, and Enderta) of Tigray and uses a cluster randomized control trial (cRCT) design. Randomization was conducted at the village level (the sub-administrative unit below the kebele), stratified by kebele. The total number of villages included in the sample is 222 across 61 kebeles.
Within each kebele, villages were randomized to receive one of the three experimental arms described below;
• Control: no intervention
• Treatment 1: gPM+ delivered by HEWs
• Treatment 2: gPM+ delivered by LFs
Within T2, there was a further sub-randomization in which villages were randomly assigned to either a male or female LF.

Each HEW (who are all women) was assigned to facilitate one gPM+ group for men and one gPM+ group for women, and thus, eight men and eight women were recruited for gPM+ in each village served by a HEW. Male LFs were assigned to facilitate gender-matched gPM+ groups, while female LFs were assigned to facilitate one male gPM+ group and one female gPM+ group. Thus, in villages served by male LFs, 16 men were recruited to participate in gPM+, while in villages served by female LFs, eight women and eight men were recruited.

In both HEW and LF arms, individuals recruited to participated in gPM+ were PSNP clients (either direct support or public works) of working-age (between 18 and 64 years old), who were heads of household or the spouse of the household head, and who exhibited signs of moderate to moderately severe depression (PHQ-9 score between 10 and 19, inclusive).
Experimental Design Details
Not available
Randomization Method
Randomization was done in an office using STATA.
Randomization Unit
Unit of randomization was the village.
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
222 villages
Sample size: planned number of observations
3,552 individuals
Sample size (or number of clusters) by treatment arms
70 control villages; 64 HEW villages, 88 LF villages (44 male and 44 female)
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
International Food Policy Research Institute
IRB Approval Date
2024-02-06
IRB Approval Number
PGI-24-0205
IRB Name
Ethiopian Public Health Association
IRB Approval Date
2024-03-08
IRB Approval Number
EPHA/OG/195/24
Analysis Plan

Analysis Plan Documents

Are government or non-governmental organization staff more effective in delivering frontline mental health services? Evidence from a cluster randomized controlled trial

MD5: d1f4ff4b671b99968c2c0087bda964d0

SHA1: 2b6b04a6a5704ba7bc16fcbf68524704c1588fbd

Uploaded At: July 30, 2024