RecruitingNot ApplicableNCT06208852

Virtual Patient Navigation During a Pandemic

The Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Virtual Patient Navigation During a Pandemic


Sponsor

Children's Hospital of Philadelphia

Enrollment

40 participants

Start Date

Jun 29, 2023

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria14

  • 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participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, are actively enrolled, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT.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 Criteria15

  • 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

Interventions

OTHERVirtual Navigator Program

For the intervention phase of the sub-study, 30 women with persistent PPD symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period. These women will be enrolled and consented to receive virtual patient navigation for 2 months. Investigators will conduct rapid cycle testing in which we will evaluate satisfaction, feasibility, and target engagement of the intervention after every 10 participants in order to make rapid cycle changes prior to enrolling the next 10 participants. Women will communicate virtually with the PN by means of telephone, text messaging, Facetime, or other virtual modality of their choice. The Primary Navigator (PN) will meet with families at the beginning of the study to review results of depression screens and community mental health (MH) resources. The PN will partner with participants, engage them in the program, and provide ongoing communication with participants and MH clinicians.


Locations(1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT06208852


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