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

NCT ID: NCT02526355

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-08-31

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.

Conditions

Maternal Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mobile based Intervention

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

Group Type: EXPERIMENTAL

Mobile based intervention

Intervention Type: BEHAVIORAL

Learning through Play Plus Intervention delivered through mobile phone

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mobile based intervention

Learning through Play Plus Intervention delivered through mobile phone

Intervention Type: BEHAVIORAL

Other Intervention Names

Intelligent Real Time Therapy iRTT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pakistan Institute of Living and Learning

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nusrat Husain, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

Jinnah Hospital

Lahore, Punjab Province, Pakistan

Chiniot Maternity Hospital

Karachi, Sindh, Pakistan

Sobhraj Maternity hospital

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

TechMotherCare001

Identifier Type: -

Identifier Source: org_study_id