A Virtual Support Intervention for Postnatal Well-being

August 13, 2024 updated by: Arshed Muhammad, Universiti Putra Malaysia

Empowering Early Parenthood: A Digital Psychoeducational Support Intervention for Postnatal Well-being

Postnatal depression (PND) and anxiety are significant public health concerns affecting a substantial proportion of new mothers worldwide. These conditions can have profound consequences for both maternal and infant well-being, including increased risk of

  1. maternal morbidity
  2. impaired parent-infant bonding
  3. long-term developmental challenges for the child.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Despite the prevalence and impact of PND and anxiety, access to timely and effective mental health care for postpartum women remains limited, particularly in resource-constrained settings.

Limited Research: There has been a historical underinvestment in mental health research in Pakistan, especially in maternal mental health.

Cultural Stigma: Mental health issues, particularly postpartum depression, are often stigmatized, leading to underreporting.

Data Infrastructure: Robust data collection and analysis systems for mental health are still developing in Pakistan The rationale for this study is grounded in the significant public health burden imposed by postnatal depression (PND) and anxiety, coupled with the limitations of traditional care models. Despite advancements in maternal and child health, postpartum mental health remains a neglected area in many countries, including Pakistan.

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pakistani female aged 18-45 years
  • Recent childbirth (within 0-6 weeks)
  • Access to a smartphone or computer with internet connectivity
  • Able to understand and communicate in Urdu or English
  • Willing to provide informed consent

Exclusion Criteria:

  • Pre-existing severe mental illness (e.g., schizophrenia, bipolar disorder)
  • Current substance abuse or dependence
  • Limited or no access to the internet or smartphone
  • Inability to understand or communicate in Urdu or English
  • Pregnancy complications requiring intensive care
  • Infants with severe medical conditions requiring hospitalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
A virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion.
Behavioral: Digital Infant- parents support
A virtual and in-person, personal and group-based intervention will be delivered-educational information on infant behavior and changes in interpersonal dynamics associated with parenting. Modules aimed at understanding and managing infant behavior include information on infant temperament. Personal support will be provided by face-to-face education and WhatsApp messages and videos. Group support will be provided by mothers and their partners or a support person group discussion.
No Intervention: Control
No intervention will be provided except usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post natal depression
Time Frame: Post natal Depression measured at baseline and 12 months
Edinburgh Postnatal Depression Scale (EPDS): A standardized self-report questionnaire to assess symptoms of postnatal depression. Scores are between 0 and 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. Scores of 13 indicate an 80% chance that the mother has depression.
Post natal Depression measured at baseline and 12 months
Post natal anxiety
Time Frame: Post natal Anxiety measured at baseline and 12 months
Generalized Anxiety Disorder-7 (GAD-7): A self-report measure to assess symptoms of generalized anxiety disorder. The GAD-7 scores were also represented with clinical categorizations of anxiety levels as follows: GAD-7 score of 0-4 (none), 5-9 (mild), 10-14 (moderate), and 15-21 (severe).
Post natal Anxiety measured at baseline and 12 months
Intervention usage
Time Frame: Intervention usage measured at 12 months
Intervention usage will be assessed by tracking participants' engagement with the online platform, including login frequency, module completion, and time spent on the platform.
Intervention usage measured at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Collaborators

University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

July 15, 2025

Study Completion (Estimated)

August 10, 2025

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol, Statistical plan, Results will be desseminated through publications

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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