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

Maternal Depression Clinical Trial

— TechMother  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526355
• Other study ID #: TechMotherCare001
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2019

Study information

• Verified date: April 2022
• Source: Pakistan Institute of Living and Learning
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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 information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Maternal Depression

Intervention

Behavioral:
• Mobile based intervention
Learning through Play Plus Intervention delivered through mobile phone

Locations

Country	Name	City	State
Pakistan	Chiniot Maternity Hospital	Karachi	Sindh
Pakistan	Sobhraj Maternity hospital	Karachi	Sindh
Pakistan	Jinnah Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Pakistan Institute of Living and Learning

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client Satisfaction Questionnaire (CSQ)	To assess participants' level of satisfaction with the treatment	3rd month
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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