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Development and Evaluation of SM-ART Intervention (SM-ART) (SM-ART)

Primary Purpose

Perinatal Depression, Resilience, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
SM-ART
Sponsored by
Aga Khan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Perinatal Depression focused on measuring Resilience, Perinatal mental health, Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. All participants should provide written consent, be 18+ years of age
  2. All participants should be currently married at a gestational age of 12 to 30 weeks: by 12th week, pregnancy is confirmed, they do visit health clinic and upper bar is set to 30 weeks so there should be adequate time to provide the intervention and observe the effectiveness.
  3. Participants should speak and understand urdu, as all our assessments and intervention will be in local language.

Exclusion Criteria:

Participants with a history of mental illness and/or physical illness will be excluded as will those taking antianxiety, antidepressant, anti psychotic medication.

Sites / Locations

  • Koohi Goth Women Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SM-ART Intervention

Control Group

Arm Description

Intervention group will receive SM-ART module training along with the flyers on resilience building tips.

Control group will only receive flyer on resilience building tips

Outcomes

Primary Outcome Measures

Change in Resilience Score
Resilience Scale 14: This is a 14 items scale which score ranges from 14 to 98. It represent all five characteristics of resilience: A purposeful life, Perseverance, Equanimity, Self-reliance and Existential aloneness. A higher total score indicates higher resilience. The scale also have cutoffs as well. The scale is validated in Pakistani population by the current study principle investigator.

Secondary Outcome Measures

Change in Depression score
Edinburgh Postnatal Depression Scale (EPDS):10-item; range 0-30, cut-off 13; across 15 countries including some LMIC Cronbach's α=.73-.87; 3 to 12 week test-retest=.53-.74) measures depression.
Change in Pregnancy related Anxiety score
Pregnancy-related anxiety scale-revised, (10 items; range 10-40; Cronbach's α=.78) evaluates feelings about health during pregnancy, health of fetus/infant, and labour and delivery.
Change in Marital Adjustment score
Locke Wallace Marital Adjustment Test (15 Items) It focuses on the aspects like participation in shared activities, display of affection and spouse agreement on important matters related to marital adjustment. It is an extensively used self-report measure of adjustment in marriage. The scale scores range from 2-158. A score less than 100 indicate marital distress.

Full Information

First Posted
December 31, 2020
Last Updated
February 16, 2022
Sponsor
Aga Khan University
Collaborators
University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04694261
Brief Title
Development and Evaluation of SM-ART Intervention (SM-ART)
Acronym
SM-ART
Official Title
Resilience, Depression And Anxiety Among Pregnant Women In Pakistan: Development And Testing Of Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aga Khan University
Collaborators
University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The approach of this intended research is to help pregnant women practice constructive coping and proactive skills that focus on positive adaptation for safe motherhood through our developed intervention. The objective of this two phases Randomized Control Trial is to develop contextually based "SM-ART" intervention [Safe Motherhood ART: Accessible Resilience Training] and evaluate the effectiveness of "SM-ART" intervention in a sample of pregnant women living in low socioeconomic urban areas of Karachi, Pakistan. It is hypothesized that the SM-ART intervention will enhance resilience and marital harmony and decrease symptoms of depression, anxiety in pregnant women.
Detailed Description
The prevalence of perinatal depression and anxiety in South Asia are among the highest in the world. In Pakistan, approximately 18% to 60% of women experienced depressive symptoms at some point during their pregnancy. Early intervention for the management of mental illness in pregnancy is imperative as the effects of perinatal mental ill-health is not only limited to mothers but also can negatively impact child health outcomes. In a public health context, positive psychological interventions should be promoted as it reduces the burden of treatment, and enhance cost effective approaches in resource poor countries such as Pakistan. As in Pakistan, no program has been planned and tested to enhance the positive psychological wellbeing among pregnant women that is based on individual strengths, that can be learnt, sustained and low cost as well. Hence, this study aims to facilitate pregnant women in practicing constructive coping and proactive skills which will help them to focus more on the positive approach of life rather than looking for the negative situations that is carried out in their daily lives. The study will carried out in two phases: Phase I: The objective of phase one is study is to develop "SM-ART" intervention [Safe Motherhood ART: Accessible Resilience Training] Phase II: The objective of phase two is to test the effectiveness of "SM-ART" intervention [Safe Motherhood ART: Accessible Resilience Training] to improve resilience, marital harmony and decrease depression and pregnancy related anxiety in a sample of pregnant women presenting to Koohi Goth Hospital of Karachi, Pakistan

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Depression, Resilience, Anxiety, Marital Conflict
Keywords
Resilience, Perinatal mental health, Depression

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The assessments will be carried out parallel in the intervention and the control arm.
Masking
Outcomes Assessor
Masking Description
The outcome assessors will not be aware about the allocation of assignments between intervention and control arm
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SM-ART Intervention
Arm Type
Experimental
Arm Description
Intervention group will receive SM-ART module training along with the flyers on resilience building tips.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group will only receive flyer on resilience building tips
Intervention Type
Behavioral
Intervention Name(s)
SM-ART
Intervention Description
Intervention is a group based training delivered by midwives on SM-ART module. These training will consist of 6 sessions, one per week for 90 to 120 minutes each.
Primary Outcome Measure Information:
Title
Change in Resilience Score
Description
Resilience Scale 14: This is a 14 items scale which score ranges from 14 to 98. It represent all five characteristics of resilience: A purposeful life, Perseverance, Equanimity, Self-reliance and Existential aloneness. A higher total score indicates higher resilience. The scale also have cutoffs as well. The scale is validated in Pakistani population by the current study principle investigator.
Time Frame
Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Secondary Outcome Measure Information:
Title
Change in Depression score
Description
Edinburgh Postnatal Depression Scale (EPDS):10-item; range 0-30, cut-off 13; across 15 countries including some LMIC Cronbach's α=.73-.87; 3 to 12 week test-retest=.53-.74) measures depression.
Time Frame
Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Title
Change in Pregnancy related Anxiety score
Description
Pregnancy-related anxiety scale-revised, (10 items; range 10-40; Cronbach's α=.78) evaluates feelings about health during pregnancy, health of fetus/infant, and labour and delivery.
Time Frame
Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)
Title
Change in Marital Adjustment score
Description
Locke Wallace Marital Adjustment Test (15 Items) It focuses on the aspects like participation in shared activities, display of affection and spouse agreement on important matters related to marital adjustment. It is an extensively used self-report measure of adjustment in marriage. The scale scores range from 2-158. A score less than 100 indicate marital distress.
Time Frame
Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All participants should provide written consent, be 18+ years of age All participants should be currently married at a gestational age of 12 to 30 weeks: by 12th week, pregnancy is confirmed, they do visit health clinic and upper bar is set to 30 weeks so there should be adequate time to provide the intervention and observe the effectiveness. Participants should speak and understand urdu, as all our assessments and intervention will be in local language. Exclusion Criteria: Participants with a history of mental illness and/or physical illness will be excluded as will those taking antianxiety, antidepressant, anti psychotic medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shireen S Bhamani, PhD Student
Organizational Affiliation
Aga Khan University School of Nursing & Midwifery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olivier Degomme
Organizational Affiliation
University Ghent
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
An-Sofie Van Parys
Organizational Affiliation
University Ghent
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Arthur
Organizational Affiliation
Aga Khan University
Official's Role
Study Director
Facility Information:
Facility Name
Koohi Goth Women Hospital
City
Karachi
State/Province
Sindh
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be analyzed using unique identifier and only the password protected data may be shared with the supervisory team of researchers.

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Development and Evaluation of SM-ART Intervention (SM-ART)

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