Technology Assisted Cascade Training and Supervision of Community Health Workers for Thinking Healthy Programme (THP-TACTS)

February 23, 2017 updated by: Human Development Research Foundation, Pakistan

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

The Thinking Healthy Program is evidence based psychological intervention, delivered by non-specialists, with proven impact on maternal depression. A major challenge in the scale-up of this intervention, especially where health systems are weak, is providing quality training and supervision at scale. Women living in post-conflict areas are at a higher risk of depression than the general population.The key innovation proposed is the development and evaluation of a technology-assisted cascade training and supervision system to assist scale-up of the Thinking Healthy Programme in a post conflict area of Pakistan.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Lady health workers currently working in Swat district

Exclusion Criteria:

  • Physically unwell, lady health workers on leave

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Technology Arm
5 days training of health workers in THP through avatar assisted cascade training and supervision
Other: Avatar assisted cascade training
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
Other: Specialist led training in THP
Training and supervision of lady health workers by specialists as in original THP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Human Development Research Foundation, Pakistan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke University
University of Liverpool

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 1, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GCC-THP-TACTS-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Maternal Depression

Clinical Trials on Avatar assisted cascade training

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings