- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02644902
Technology Assisted Cascade Training and Supervision of Community Health Workers for Thinking Healthy Programme (THP-TACTS)
Effectiveness of Technology Assisted Cascade Training and Supervision of Community Health Workers in Delivering Thinking Healthy Program for Perinatal Depression in a Post-conflict Area of Pakistan- Protocol of a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Thinking Healthy Program (THP) is a cognitive behaviour therapy (CBT)-based intervention for maternal depression, delivered by non-specialists.In a recent meta-analysis commissioned by the WHO, THP was shown to have a large effect and has been adopted by the WHO for global dissemination through its mhGAP programme. A major challenge in the scaling up of this evidence-based intervention is the provision of training and supervision at scale, especially in post-conflict areas with weak health systems. The investigators aim to meet this challenge by providing technology based solutions to training and supervision. Building on the organization's previous work in this area, investigators aim to develop Avatar-assisted cascade training and supervision system that includes: (a) a interactive voice response system for phone based assessment to screen depression in the community; (b) a Tablet-based manual , using special characters or avatars allowing standardized training to be delivered without the need for a specialist trainer; and (c) a cascade training model whereby specialists supervise, from distance, the community health worker program supervisors, who in turn, supervise the community health workers (CHW) as part of their normal routine.
The Lady Health Worker (LHW) Programme covers 85% of Pakistan's rural population through 115,000 LHWs . If this study is able to provide a technological solution to the training and supervision of health workers, they have the potential to provide treatment to an estimated 5 million women in rural Pakistan with maternal depression.
Investigators intend conducting the study in District Swat affected by multiple humanitarian crises in recent years. Swat has a population of 1,257,602 persons, 86% of whom live in rural areas with the average household size of 8.8 persons with a low female literacy. The resurgence of the Taliban movement in the Swat Valley of Pakistan since 2004, and the military operations in 2009 and the displacement of residents created a humanitarian crisis in the area. The devastating floods of 2010 put thousands of people out of their homes, and caused destruction to houses, roads, schools and health facilities.The health infrastructure of a post conflict zone like Swat is particularly fragile with the health workers under threat of being attacked, limiting their mobility. Mental health impacts of conflict are often severe and may not be depicted in the national statistics.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Lady health workers currently working in Swat district
Exclusion Criteria:
- Physically unwell, lady health workers on leave
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Technology Arm
5 days training of health workers in THP through avatar assisted cascade training and supervision
|
Training of health workers in THP through tablets including avatar characters , and cascaded supervision model.
|
Active Comparator: Specialist Arm
5 days training and supervision of health workers in THP by specialists
|
Training and supervision of lady health workers by specialists as in original THP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Competency of health workers in THP skills measured using ENact assessment tool
Time Frame: Immediately after intervention
|
The competency of health workers in the two arms will be measured using ENact assessment tool.
|
Immediately after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost of intervention
Time Frame: 3 months after intervention
|
Cost of intervention and comparative arm will be assessed from data collected during the trial and analyzed after 3 months.
|
3 months after intervention
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCC-THP-TACTS-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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