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

A

Aga Khan University

Status

Completed

Conditions

Marital Conflict
Perinatal Depression
Resilience
Anxiety

Treatments

Behavioral: SM-ART

Study type

Interventional

Funder types

Other

Identifiers

NCT04694261
5312-SON-ERC-18.
70345 (182015SONAM) (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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

Enrollment

200 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

SM-ART Intervention
Experimental group
Description:
Intervention group will receive SM-ART module training along with the flyers on resilience building tips.
Treatment:
Behavioral: SM-ART
Control Group
No Intervention group
Description:
Control group will only receive flyer on resilience building tips

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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