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

Sponsor
Pakistan Institute of Living and Learning (Other)
Overall Status
Completed
CT.gov ID
NCT02526355
Collaborator
(none)
208
3
2
43
69.3
1.6

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mobile based intervention
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
208 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Development and Assessment of a Mobile Phone Based Intervention to Reduce Maternal Depression and Improve Child Health
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Aug 1, 2019
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mobile based Intervention

Mobile based Intervention (Learning Through Play Plus) comprised of both LTP and CBT

Behavioral: Mobile based intervention
Learning through Play Plus Intervention delivered through mobile phone
Other Names:
  • Intelligent Real Time Therapy iRTT
  • No Intervention: Waiting List Control

    Waiting List Control group will receive no intervention, but intervention will be offered to interested participants at the end of the study

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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.

    4. 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.

    5. 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

    6. 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

    7. 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

    Other Outcome Measures

    1. Client Satisfaction Questionnaire (CSQ) [3rd month]

      To assess participants' level of satisfaction with the treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 44 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jinnah Hospital Lahore Punjab Pakistan +92
    2 Chiniot Maternity Hospital Karachi Sindh Pakistan
    3 Sobhraj Maternity hospital Karachi Sindh Pakistan

    Sponsors and Collaborators

    • Pakistan Institute of Living and Learning

    Investigators

    • Principal Investigator: Nusrat Husain, MD, University of Manchester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pakistan Institute of Living and Learning
    ClinicalTrials.gov Identifier:
    NCT02526355
    Other Study ID Numbers:
    • TechMotherCare001
    First Posted:
    Aug 18, 2015
    Last Update Posted:
    Apr 25, 2022
    Last Verified:
    Apr 1, 2022
    Keywords provided by Pakistan Institute of Living and Learning
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 25, 2022