NCT02644902

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

6 months

First QC Date

December 28, 2015

Last Update Submit

February 23, 2017

Conditions

Keywords

Avatar assisted cascade training and supervisionmaternal depressionpostconflictTHP

Outcome Measures

Primary Outcomes (1)

  • Competency of health workers in THP skills measured using ENact assessment tool

    The competency of health workers in the two arms will be measured using ENact assessment tool.

    Immediately after intervention

Secondary Outcomes (1)

  • Cost of intervention

    3 months after intervention

Study Arms (2)

Technology Arm

EXPERIMENTAL

5 days training of health workers in THP through avatar assisted cascade training and supervision

Other: Avatar assisted cascade training

Specialist Arm

ACTIVE COMPARATOR

5 days training and supervision of health workers in THP by specialists

Other: Specialist led training in THP

Interventions

Training of health workers in THP through tablets including avatar characters , and cascaded supervision model.

Technology Arm

Training and supervision of lady health workers by specialists as in original THP

Specialist Arm

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Lady health workers currently working in Swat district

You may not qualify if:

  • Physically unwell, lady health workers on leave

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Zafar S, Sikander S, Hamdani SU, Atif N, Akhtar P, Nazir H, Maselko J, Rahman A. The effectiveness of Technology-assisted Cascade Training and Supervision of community health workers in delivering the Thinking Healthy Program for perinatal depression in a post-conflict area of Pakistan - study protocol for a randomized controlled trial. Trials. 2016 Apr 6;17:188. doi: 10.1186/s13063-016-1308-2.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2015

First Posted

January 1, 2016

Study Start

March 1, 2016

Primary Completion

September 1, 2016

Study Completion

October 1, 2016

Last Updated

February 24, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share