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

NCT04694261 | Completed DMC

• 2 other identifiers: 5312-SON-ERC-18.70345 (182015SONAM)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Perinatal Depression; Resilience; Anxiety; Marital Conflict

Keywords

Resilience; Perinatal mental health; Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

Secondary Outcomes (3)

• Change in Depression score

  Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

• Change in Pregnancy related Anxiety score

  Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

• Change in Marital Adjustment score

  Baseline ( at the time of enrolment) and Post assessment (within two weeks of intervention)

Study Arms (2)

SM-ART Intervention

EXPERIMENTAL

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

Behavioral: SM-ART

Control Group

NO INTERVENTION

Control group will only receive flyer on resilience building tips

Interventions

SM-ART 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.

SM-ART Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Aga Khan University: lead
• University Ghent: collaborator

Study Sites (1)

Koohi Goth Women Hospital

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• Bhamani SS, Van Parys AS, Arthur D, Letourneau N, Wagnild G, Degomme O. Promoting mental wellbeing in pregnant women living in Pakistan with the Safe Motherhood-Accessible Resilience Training (SM-ART) intervention: a randomized controlled trial. BMC Pregnancy Childbirth. 2024 Jun 29;24(1):452. doi: 10.1186/s12884-024-06629-2.

  PMID: 38951777 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Shireen S Bhamani, PhD Student

  Aga Khan University School of Nursing & Midwifery

  PRINCIPAL INVESTIGATOR

• Olivier Degomme

  University Ghent

  STUDY CHAIR

• An-Sofie Van Parys

  University Ghent

  STUDY DIRECTOR

• David Arthur

  Aga Khan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessors will not be aware about the allocation of assignments between intervention and control arm
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

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

Study Record Dates

• First Submitted: December 31, 2020
• First Posted: January 5, 2021
• Study Start: July 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: March 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)