Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health (TechMother)

April 22, 2022 updated by: Pakistan Institute of Living and Learning

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Disturbances in mother-infant relationship in depressed mothers negatively influence the child's development. There are a number of efficient treatments for postnatal depression including antidepressant medication, psychotherapy and psychosocial interventions. Tele-health and mobile health is a novel and emerging field in psychiatric and psychological care and treatment of mental health difficulties, it involves the use of telecommunications to provide health care, support and intervention from a distance.

The proposed study will test the efficacy of an innovative, affordable mobile based intervention program that can help mothers with postnatal depression in low resource countries such as Pakistan.

Participants will be recruited from maternal and child care centres in Karachi, Pakistan and those participants (n = 204) meeting inclusion criteria of the study will be randomized into one of the 2 treatment arms, i.e., intervention or control, after completion of baseline assessment. Intervention will be comprised of LTP Plus and will be delivered through text messages. Momentary Sampling assessment and Momentary Psychological intervention will be part of this study. Participants will be assessed again after completion of intervention (i.e., after 12 weeks) and then 3 months post intervention.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, +92
        • Jinnah Hospital
    • Sindh
      • Karachi, Sindh, Pakistan
        • Chiniot Maternity Hospital
      • Karachi, Sindh, Pakistan
        • Sobhraj Maternity hospital

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

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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
Intervention / Treatment
Experimental: Mobile based Intervention
Mobile based Intervention (Learning Through Play Plus) comprised of both LTP and CBT
Behavioral: Mobile based intervention
Learning through Play Plus Intervention delivered through mobile phone
Other Names:
  • Intelligent Real Time Therapy iRTT
No Intervention: Waiting List Control
Waiting List Control group will receive no intervention, but intervention will be offered to interested participants at the end of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: change in scores from baseline to 3rd month and 6th month
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9)
Time Frame: change in scores from baseline to 3rd month and 6th month
PHQ-9 will be used to assess the severity of depression
change in scores from baseline to 3rd month and 6th month
EuroQoL-5 Dimensions (EQ-5D)
Time Frame: change in scores from baseline to 3rd month and 6th month
EQ-5D will be used to assess the health related quality of life
change in scores from baseline to 3rd month and 6th month
Generalized Anxiety Disorder - 7 (GAD-7)
Time Frame: change in scores from baseline to 3rd month and 6th month
GAD 7 will be used to assess severity of anxiety.
change in scores from baseline to 3rd month and 6th month
Knowledge of Expectation and Child Development
Time Frame: change in scores from baseline to 3rd month and 6th month
25-item questionnaire will be used to assess maternal knowledge and expectations for child development in the first three years. Higher scores indicate better outcomes.
change in scores from baseline to 3rd month and 6th month
Clinical Interview Schedule Revised (CISR)
Time Frame: Change in scores from baseline to 3rd month and 6th month
The clinical Interview Schedule-Revised is a structured diagnostic instrument that was developed from the Clinical Interview Schedule (CIS), to assess psychiatric problems
Change in scores from baseline to 3rd month and 6th month
Assessment of the growth and development of children (Weight)
Time Frame: Change in scores from Baseline and 6 month
Anthropometric measures of child growth will be collected through measuring children's weight in kilograms. weight and height will be combined to report BMI in kg/m^2
Change in scores from Baseline and 6 month
Assessment of the growth and development of children (Height)
Time Frame: Change in scores from Baseline and 6 month
Anthropometric measures of child growth will be collected through measuring children height in meters. weight and height will be combined to report BMI in kg/m^2
Change in scores from Baseline and 6 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Client Satisfaction Questionnaire (CSQ)
Time Frame: 3rd month
To assess participants' level of satisfaction with the treatment
3rd month

Collaborators and Investigators

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

Sponsor

Pakistan Institute of Living and Learning

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)

January 1, 2016

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

November 15, 2014

First Submitted That Met QC Criteria

August 15, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TechMotherCare001

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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