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Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity (ROSHNI)

Primary Purpose

Maternal Depression

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Learning Through Play Plus
Sponsored by
Pakistan Institute of Living and Learning
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Depression focused on measuring Maternal depression, Mother, Child, LTP, Learning Through Play, Healthy thinking

Eligibility Criteria

18 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants will be included in the study if they are:

    • 18 to 44 years old Mothers with children aged between 0-30 months
    • Resident in the trial site catchments area
    • Ability to complete a baseline assessment

Exclusion Criteria:

  • Participants will be excluded from the study if they have:

    • A medical disorder that would prevent participation in clinical trial.
    • Temporary resident unlikely to be available for follow up.
    • Active suicidal ideation or any other severe or physical mental disorder

Sites / Locations

  • Community, Gadap

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Arm

Control

Arm Description

Learning Through Play Plus

This arm will receive no intervention

Outcomes

Primary Outcome Measures

EPDS
The EPDS is a self-report questionnaire composed of ten items scored on a four-point scale (0-3) designed to assess pregnancy and postpartum depression Cox et al. (1987).

Secondary Outcome Measures

Knowledge of Expectation and Child Development
A 20-item questionnaire will be used to assess maternal knowledge and expectations for child development in the first three years. A change in mothers' knowledge was reported for Pakistani mothers who participated in LTP (Rahman et al, 2009).
Patient Health Questionnaire (PHQ) (Kroenke, Spitzer, Williams et al, 2001)
The Patient health Questionnaire (PHQ) is a simple 10 item self-report questionnaire can also be administered by a trained research worker. A score of 10 or more is taken as cut -off for depressive disorder
Generalized Anxiety Disorder (GAD) 7 (Spitzer, R. L., Kroenke, K., Williams, J. B., & Lowe, B. 2006)
The GAD-7 is a 7 item scale used to screen for and measure severity of Genralised Anxiety Disorder. Scores of 5, 10 & 15 are taken as cut-off points for mild, moderate and high
Clinical Interview Schedule Revised (CISR)
The clinical Interview Schedule-Revised is a fully structured diagnostic instrument that was developed from an existing instrument, the Clinical Interview Schedule (CIS), assessing minor psychiatric morbidity in the community, general hospital, occupational and primary care research
Quality of life (EQ 5 D)
It is a measure of health and quality of life. This is a standardised instrument for use as a measure of health outcome; it provides a simple descriptive profile and a single index value for health status.

Full Information

First Posted
January 21, 2014
Last Updated
October 26, 2017
Sponsor
Pakistan Institute of Living and Learning
Collaborators
Grand Challenges Canada, The Hincks-Dellcrest Centre
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1. Study Identification

Unique Protocol Identification Number
NCT02047357
Brief Title
Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity
Acronym
ROSHNI
Official Title
Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity- A Cluster-Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Institute of Living and Learning
Collaborators
Grand Challenges Canada, The Hincks-Dellcrest Centre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To test the efficacy of an innovative affordable intervention program that can be used by non-specialists, including mothers and lady health workers with minimal training in low resource countries such as Pakistan
Detailed Description
Specific challenges: In Pakistan rates of depression particularly in women are high, as well as other risks to the growth and development of young children and child mortality. Numerous studies provide compelling evidence that maternal depression not only affects mothers but is also associated with long term emotional, cognitive and behavioural problems in children. Depressed mothers are unable to provide primary care necessary for growth of their children during the first 3-years of life, a critical period for child development. Disability due to depressive symptoms (such as fatigue, poor concentration, loss of interest) is likely to affect child-care abilities directly, while impaired social functioning is likely to have indirect consequences through lack of support in childcare. Disturbances in mother-infant relationship in depressed mothers negatively influence the child's development. There is now evidence from some low income countries that effectively delivered participatory group interventions are cost effective intervention for improving maternal and child health. The Community-Based participatory Intervention LTP Plus has been designed to address maternal depression and a parenting program of child psychosocial development through mother-infant play providing stimulation, and support for exploration and autonomy for the infant.The proposed study will test the efficacy of an innovative affordable intervention program that can be used by non-specialists, including mothers and lay health workers with minimal training in low resource countries such as Pakistan. Project Impact: LTP Plus is proposed as a low cost intervention to improve maternal mental and physical health, reduce infant and children under five years' morbidity and mortality, and promote healthy child development. Learning Through Play (LTP) Plus is a low-literacy, sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach, THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Depression
Keywords
Maternal depression, Mother, Child, LTP, Learning Through Play, Healthy thinking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
774 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Learning Through Play Plus
Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm will receive no intervention
Intervention Type
Other
Intervention Name(s)
Learning Through Play Plus
Other Intervention Name(s)
Psycho social intervention
Intervention Description
Learning Through Play (LTP) Plus is a low-literacy, sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.
Primary Outcome Measure Information:
Title
EPDS
Description
The EPDS is a self-report questionnaire composed of ten items scored on a four-point scale (0-3) designed to assess pregnancy and postpartum depression Cox et al. (1987).
Time Frame
Change from Baseline to 3 month
Secondary Outcome Measure Information:
Title
Knowledge of Expectation and Child Development
Description
A 20-item questionnaire will be used to assess maternal knowledge and expectations for child development in the first three years. A change in mothers' knowledge was reported for Pakistani mothers who participated in LTP (Rahman et al, 2009).
Time Frame
Baseline, 3 months and 6 months
Title
Patient Health Questionnaire (PHQ) (Kroenke, Spitzer, Williams et al, 2001)
Description
The Patient health Questionnaire (PHQ) is a simple 10 item self-report questionnaire can also be administered by a trained research worker. A score of 10 or more is taken as cut -off for depressive disorder
Time Frame
Baseline, 3 month and 6 month
Title
Generalized Anxiety Disorder (GAD) 7 (Spitzer, R. L., Kroenke, K., Williams, J. B., & Lowe, B. 2006)
Description
The GAD-7 is a 7 item scale used to screen for and measure severity of Genralised Anxiety Disorder. Scores of 5, 10 & 15 are taken as cut-off points for mild, moderate and high
Time Frame
Baseline, 3 month and 6 month
Title
Clinical Interview Schedule Revised (CISR)
Description
The clinical Interview Schedule-Revised is a fully structured diagnostic instrument that was developed from an existing instrument, the Clinical Interview Schedule (CIS), assessing minor psychiatric morbidity in the community, general hospital, occupational and primary care research
Time Frame
Baseline, 3 month and 6 month
Title
Quality of life (EQ 5 D)
Description
It is a measure of health and quality of life. This is a standardised instrument for use as a measure of health outcome; it provides a simple descriptive profile and a single index value for health status.
Time Frame
Baseline, 3 month and 6 month
Other Pre-specified Outcome Measures:
Title
Cost effectiveness analysis
Description
It is used for evaluating cost effectiveness analysis
Time Frame
Baseline, 3 month and 6 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will be included in the study if they are: 18 to 44 years old Mothers with children aged between 0-30 months Resident in the trial site catchments area Ability to complete a baseline assessment Exclusion Criteria: Participants will be excluded from the study if they have: A medical disorder that would prevent participation in clinical trial. Temporary resident unlikely to be available for follow up. Active suicidal ideation or any other severe or physical mental disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Batool Fatima
Organizational Affiliation
Pakistan Institute of Living and Learning
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nancy Cohen, Ph.D
Organizational Affiliation
The Hincks-Dellcrest Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community, Gadap
City
Karachi
State/Province
Sindh
ZIP/Postal Code
75780
Country
Pakistan

12. IPD Sharing Statement

Links:
URL
http://pill.org.pk
Description
Pakistan Institute of learning and living

Learn more about this trial

Participatory Intervention to Reduce Maternal Depression and Under Five Child Morbidity

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