NCT02526355

Brief Summary

The prevalence rate of maternal depression in Pakistani women and its effect on the growth and development of young children and child mortality is very high. The main objective of this study is to increase access to evidence based psychological interventions for mothers who have children of age 0 to 30 months, consistent with her values. The study will be a 2 (conditions) into 3 (Time) single blind randomized controlled trail. Depressed mothers will be randomized either to intervention arm or control arm. Intervention will include text messages based on Learning Through Play Plus (LTP plus CBT).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

3.6 years

First QC Date

November 15, 2014

Last Update Submit

April 22, 2022

Conditions

Maternal Depression

Keywords

Maternal depressionMobile phone based interventionLearning Through PlayCBTIntelligent Real Time Therapy

Outcome Measures

Primary Outcomes (1)

  • Edinburgh Postnatal Depression Scale (EPDS)

    EPDS will be used to screen depression in mothers with child 0-30 months.

    change in scores from baseline to 3rd month and 6th month

Secondary Outcomes (7)

  • Patient Health Questionnaire (PHQ-9)

    change in scores from baseline to 3rd month and 6th month

  • EuroQoL-5 Dimensions (EQ-5D)

    change in scores from baseline to 3rd month and 6th month

  • Generalized Anxiety Disorder - 7 (GAD-7)

    change in scores from baseline to 3rd month and 6th month

  • Knowledge of Expectation and Child Development

    change in scores from baseline to 3rd month and 6th month

  • Clinical Interview Schedule Revised (CISR)

    Change in scores from baseline to 3rd month and 6th month

  • +2 more secondary outcomes

Other Outcomes (1)

  • Client Satisfaction Questionnaire (CSQ)

    3rd month

Study Arms (2)

Mobile based Intervention

EXPERIMENTAL

Mobile based Intervention (Learning Through Play Plus) comprised of both LTP and CBT

Behavioral: Mobile based intervention

Waiting List Control

NO INTERVENTION

Waiting List Control group will receive no intervention, but intervention will be offered to interested participants at the end of the study

Interventions

Mobile based interventionBEHAVIORAL

Learning through Play Plus Intervention delivered through mobile phone

Also known as: Intelligent Real Time Therapy iRTT
Mobile based Intervention

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mothers with mild to moderate depression will be included
  • Mother of children age 0-30months
  • The age range in the study is 18 to 44 years
  • Participants having mobile phones will be included

You may not qualify if:

  • Subjects will not be included if they had a diagnosed medical condition or significant physical or learning disability
  • Any form of psychosis, or are currently under psychiatric care.
  • Mothers with severe depression or suicidal ideation will not be included
  • Mothers who will be receiving any psychological intervention will be excluded
  • Mothers of children with any serious medical or psychiatric illness will also be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jinnah Hospital

Lahore, Punjab Province, +92, Pakistan

Location

Chiniot Maternity Hospital

Karachi, Sindh, Pakistan

Location

Sobhraj Maternity hospital

Karachi, Sindh, Pakistan

Location

Study Officials

  • Nusrat Husain, MD

    University of Manchester

    PRINCIPAL INVESTIGATOR

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

November 15, 2014

First Posted

August 18, 2015

Study Start

January 1, 2016

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

PA(3)