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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Perinatal Depression Resilience Anxiety Marital Conflict

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The assessments will be carried out parallel in the intervention and the control arm.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

The outcome assessors will not be aware about the allocation of assignments between intervention and control arm

Study Groups

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SM-ART Intervention

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

Group Type EXPERIMENTAL

SM-ART

Intervention Type BEHAVIORAL

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.

Control Group

Control group will only receive flyer on resilience building tips

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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SM-ART

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes