Development & Assessment of a Mobile Phone Based Intervention to Reduce

Status Completed

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02526355
Study type	Interventional
Source	Pakistan Institute of Living and Learning
Contact
Status	Completed
Phase	N/A
Start date	January 2016
Completion date	August 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms