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A Virtual Support Intervention for Postnatal Well-being

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06557200
Enrollment
1400
Registered
2024-08-16
Start date
2024-08-15
Completion date
2025-08-10
Last updated
2024-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mother-Infant Interaction, Postnatal Depression

Brief summary

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.

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.

Interventions

BEHAVIORALDigital 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.

Sponsors

University of Lahore
CollaboratorOTHER
Universiti Putra Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Participants, Care providers, and outcome assessors will be blinded

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post natal depressionPost natal Depression measured at baseline and 12 monthsEdinburgh 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 anxietyPost natal Anxiety measured at baseline and 12 monthsGeneralized 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).
Intervention usageIntervention usage measured at 12 monthsIntervention usage will be assessed by tracking participants' engagement with the online platform, including login frequency, module completion, and time spent on the platform.

Countries

Pakistan

Contacts

Primary ContactRaashed Muhammad, Master
stunning003@gmail.com03249479263

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026