Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
- Conditions
- Maternal Depression
- Interventions
- Behavioral: Mobile based intervention
- Registration Number
- NCT02526355
- Lead Sponsor
- Pakistan Institute of Living and Learning
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 208
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mobile based Intervention Mobile based intervention Mobile based Intervention (Learning Through Play Plus) comprised of both LTP and CBT
- Primary Outcome Measures
Name Time Method Edinburgh Postnatal Depression Scale (EPDS) 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.
- Secondary Outcome Measures
Name Time Method EuroQoL-5 Dimensions (EQ-5D) change in scores from baseline to 3rd month and 6th month EQ-5D will be used to assess the health related quality of life
Knowledge of Expectation and Child Development 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.
Assessment of the growth and development of children (Height) 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
Patient Health Questionnaire (PHQ-9) change in scores from baseline to 3rd month and 6th month PHQ-9 will be used to assess the severity of depression
Generalized Anxiety Disorder - 7 (GAD-7) change in scores from baseline to 3rd month and 6th month GAD 7 will be used to assess severity of anxiety.
Clinical Interview Schedule Revised (CISR) 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
Assessment of the growth and development of children (Weight) 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
Trial Locations
- Locations (3)
Chiniot Maternity Hospital
🇵🇰Karachi, Sindh, Pakistan
Jinnah Hospital
🇵🇰Lahore, Punjab, Pakistan
Sobhraj Maternity hospital
🇵🇰Karachi, Sindh, Pakistan