Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT06208852

Virtual Patient Navigation During a Pandemic

Led by Children's Hospital of Philadelphia · Updated on 2026-01-09

40

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital of Philadelphia

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The sub-study will involve a rigorous mixed-methods design. The qualitative phase of the sub-study will consist of semi-structured interviews. During the semi-structured interviews, 10 eligible women will be recruited to identify barriers and facilitators to accessing virtual mental health services. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. For the intervention phase of the sub-study, 30 women with persistent postpartum depression symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.

CONDITIONS

Official Title

Virtual Patient Navigation During a Pandemic

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women who are former participants from the R61 Phase of the Main RCT or referred, enrolled, or withdrawn from the R33 Phase of the Main RCT
  • Women older than 18 years
  • Women who speak and read English
  • Women with access to a smartphone or computer tablet with internet
  • Women with an infant younger than 12 months
  • Women not actively engaged with mental health services
  • Women who screen positive for postpartum depression with an EPDS score over 9
  • Women with access to a cellular phone with texting capabilities
Not Eligible

You will not qualify if you...

  • Women reporting suicidality on the EPDS (Question #10) at enrollment
  • Women with severe depressive symptoms (EPDS score over 20) at enrollment
  • Women with a substantiated report of child maltreatment
  • Children born premature (less than 35 weeks gestational age)
  • Children diagnosed with congenital malformations or genetic syndromes that risk developmental delays
  • Children already receiving early intervention services for developmental delays
  • Women reporting suicidality with responses "sometimes" or "yes, quite often" on EPDS Question #10 at participating pediatric practice
  • Women reporting suicidality and endorsing follow-up questions about suicidal thoughts, plans, or attempts at participating pediatric practice
  • Women with a substantiated report of child maltreatment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

J

James Guevara, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SCREENING

Number of Arms

2

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