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Completed

NCT Number: NCT02526355

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

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).

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Key information

Conditions

Maternal Depression

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Jinnah Hospital, Lahore, Punjab Province, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile based intervention

Behavioral

Learning through Play Plus Intervention delivered through mobile phone

Other names: Intelligent Real Time Therapy iRTT

Primary outcomes

  1. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: 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 outcomes

  1. Patient Health Questionnaire (PHQ-9)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Client Satisfaction Questionnaire (CSQ)

    Time frame: 3rd month

    To assess participants' level of satisfaction with the treatment

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Living and Learning

Other

Registry information

Acronym: TechMother

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 18, 2015
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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