A Virtual Support Intervention for Postnatal Well-being
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorUniversiti Putra Malaysia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Infant- parents support
BehavioralA 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.
Treatment groups
1,400 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Post natal depression
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.
Time frame
Post natal Depression measured at baseline and 12 months2
Post natal anxiety
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).
Time frame
Post natal Anxiety measured at baseline and 12 months3
Intervention usage
Intervention usage will be assessed by tracking participants' engagement with the online platform, including login frequency, module completion, and time spent on the platform.
Time frame
Intervention usage measured at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Universiti Putra Malaysia
Lead sponsor
University of Lahore
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: