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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Maternal Depression

Intervention / Treatment
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* Behavioral: Mobile based intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile based Intervention<br>Mobile based Intervention (Learning Through Play Plus) comprised of both LTP and CBT | Behavioral: Mobile based intervention<br>* Learning through Play Plus Intervention delivered through mobile phone<br>* Other names: Intelligent Real Time Therapy iRTT;|
| No Intervention: Waiting List Control<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire (PHQ-9) | 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) | 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) | 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 | 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) | 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) | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal depression, Mobile phone based intervention, Learning Through Play, CBT, Intelligent Real Time Therapy