Clinical trial NCT02526355: Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
Official title: Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maternal Depression
Keywords: Maternal depression
Mobile phone based intervention
Learning Through Play
CBT
Intelligent Real Time Therapy
Lead sponsor: Pakistan Institute of Living and Learning
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 208
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: change in scores from baseline to 3rd month and 6th month
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: change in scores from baseline to 3rd month and 6th month
measure: EuroQoL-5 Dimensions (EQ-5D)
timeFrame: change in scores from baseline to 3rd month and 6th month
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: change in scores from baseline to 3rd month and 6th month
measure: Knowledge of Expectation and Child Development
timeFrame: change in scores from baseline to 3rd month and 6th month
measure: Clinical Interview Schedule Revised (CISR)
timeFrame: Change in scores from baseline to 3rd month and 6th month
measure: Assessment of the growth and development of children (Weight)
timeFrame: Change in scores from Baseline and 6 month
measure: Assessment of the growth and development of children (Height)
timeFrame: Change in scores from Baseline and 6 month
Other outcomes:
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: 3rd month
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital
state: Punjab
city: Karachi
country: Pakistan
facility: Chiniot Maternity Hospital
state: Sindh
city: Karachi
country: Pakistan
facility: Sobhraj Maternity hospital
state: Sindh
Study officials:
affiliation: University of Manchester
name: Nusrat Husain, MD
role: PRINCIPAL_INVESTIGATOR
References: