Virtual Patient Navigation During a Pandemic
Completed · Not applicable
Conditions studied: Post-partum Depression
In brief
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.
Key facts
- Study ID
- NCT06208852
- Run by
- Children's Hospital of Philadelphia
- People needed
- 26
- Starts
- 2023-06-29
- Expected to finish
- 2026-05-31
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Qualitative Phase:
- Women who:
- Are either former participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, are actively enrolled, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT.
- Are > 18 years of age
- Speak and read in English
- Have access to a smart phone or computer tablet with internet access
- Have an infant < 12 months of age
- Intervention Phase:
- Women who:
- Are not actively engaged with MH services
- Screen positive for postpartum depression (score>9) on the EPDS
- Are > 18 years of age
- Speak and read in English
- Have access to a cellular phone with texting capabilities
You may not qualify if…
- Qualitative Phase:
- Women who:
- Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at enrollment.
- Report severe depressive symptoms (EPDS>20) at enrollment.
- Have a substantiated report of child maltreatment
- Children who:
- Were born premature (estimated gestational age<35 weeks)
- Have been diagnosed with congenital malformations or genetic syndromes which place them at risk of developmental delays
- Are already currently receiving early intervention services for developmental delays at baseline
- Intervention Phase:
- Women who:
- Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) with a response of "sometimes," or "yes, quite often" at participating pediatric practice
- Report suicidality (i,e, suicidal ideation and/or behavior) on the EPDS (Question #10) and also endorse any of the follow up questions at a participating pediatric practice:
- i. Have you ever felt that life is not worth living? ii. Has this feeling occurred in the past week? iii. Have you ever wanted to kill yourself? iv. Did you ever make a plan to kill yourself? v. Have you ever attempted suicide?
- Have a substantiated report of child maltreatment
Where it is running
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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