Status:
RECRUITING
Virtual Patient Navigation During a Pandemic
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Post-partum Depression
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
In the qualitative phase of the sub-study, 10 participants who are either former participants from the R61 Phase (IRB 19-016174) of the Main Randomized Clinical Trial (RCT), or have been referred, are...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, are actively enrolled, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT.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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
June 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06208852
Start Date
June 29 2023
End Date
June 1 2026
Last Update
January 9 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104