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

Primary Purpose

Maternal Depression

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mobile based intervention
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maternal Depression focused on measuring Maternal depression, Mobile phone based intervention, Learning Through Play, CBT, Intelligent Real Time Therapy

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Jinnah Hospital
  • Chiniot Maternity Hospital
  • Sobhraj Maternity hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile based Intervention

Waiting List Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Edinburgh Postnatal Depression Scale (EPDS)
EPDS will be used to screen depression in mothers with child 0-30 months.

Secondary Outcome Measures

Patient Health Questionnaire (PHQ-9)
PHQ-9 will be used to assess the severity of depression
EuroQoL-5 Dimensions (EQ-5D)
EQ-5D will be used to assess the health related quality of life
Generalized Anxiety Disorder - 7 (GAD-7)
GAD 7 will be used to assess severity of anxiety.
Knowledge of Expectation and Child Development
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.
Clinical Interview Schedule Revised (CISR)
The clinical Interview Schedule-Revised is a structured diagnostic instrument that was developed from the Clinical Interview Schedule (CIS), to assess psychiatric problems
Assessment of the growth and development of children (Weight)
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
Assessment of the growth and development of children (Height)
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

Full Information

First Posted
November 15, 2014
Last Updated
April 22, 2022
Sponsor
Pakistan Institute of Living and Learning
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1. Study Identification

Unique Protocol Identification Number
NCT02526355
Brief Title
Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
Acronym
TechMother
Official Title
Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression
Keywords
Maternal depression, Mobile phone based intervention, Learning Through Play, CBT, Intelligent Real Time Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile based Intervention
Arm Type
Experimental
Arm Description
Mobile based Intervention (Learning Through Play Plus) comprised of both LTP and CBT
Arm Title
Waiting List Control
Arm Type
No Intervention
Arm Description
Waiting List Control group will receive no intervention, but intervention will be offered to interested participants at the end of the study
Intervention Type
Behavioral
Intervention Name(s)
Mobile based intervention
Other Intervention Name(s)
Intelligent Real Time Therapy iRTT
Intervention Description
Learning through Play Plus Intervention delivered through mobile phone
Primary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
EPDS will be used to screen depression in mothers with child 0-30 months.
Time Frame
change in scores from baseline to 3rd month and 6th month
Secondary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ-9)
Description
PHQ-9 will be used to assess the severity of depression
Time Frame
change in scores from baseline to 3rd month and 6th month
Title
EuroQoL-5 Dimensions (EQ-5D)
Description
EQ-5D will be used to assess the health related quality of life
Time Frame
change in scores from baseline to 3rd month and 6th month
Title
Generalized Anxiety Disorder - 7 (GAD-7)
Description
GAD 7 will be used to assess severity of anxiety.
Time Frame
change in scores from baseline to 3rd month and 6th month
Title
Knowledge of Expectation and Child Development
Description
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.
Time Frame
change in scores from baseline to 3rd month and 6th month
Title
Clinical Interview Schedule Revised (CISR)
Description
The clinical Interview Schedule-Revised is a structured diagnostic instrument that was developed from the Clinical Interview Schedule (CIS), to assess psychiatric problems
Time Frame
Change in scores from baseline to 3rd month and 6th month
Title
Assessment of the growth and development of children (Weight)
Description
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
Time Frame
Change in scores from Baseline and 6 month
Title
Assessment of the growth and development of children (Height)
Description
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
Time Frame
Change in scores from Baseline and 6 month
Other Pre-specified Outcome Measures:
Title
Client Satisfaction Questionnaire (CSQ)
Description
To assess participants' level of satisfaction with the treatment
Time Frame
3rd month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nusrat Husain, MD
Organizational Affiliation
University of Manchester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
+92
Country
Pakistan
Facility Name
Chiniot Maternity Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan
Facility Name
Sobhraj Maternity hospital
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

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

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