Virtual Patient Navigation During a Pandemic

NCT06208852 | Recruiting DMC

• 3 other identifiers: 19-016174-BR61MH11840519-016174
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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

Post-partum Depression

Keywords

post-partum depression; mental health; child and maternal health; patient navigator

Outcome Measures

Primary Outcomes (4)

• Qualitative: Barriers and facilitators to virtual and in-person mental health services

  the main objective is to identify barriers and facilitators to virtual and in-person mental health services in order to adapt a patient navigation intervention for virtual use.

  Baseline

• Intervention: Target engagement of the Patient Navigator

  To determine target engagement of the virtual PN, changes in the The Barriers to Mental Health Services Scale Revised (BMHSS-R ) measured at baseline and at the 2-month follow-up visit will be assessed.

  Baseline, 2 months.

• Intervention: Feasibility

  To assess the feasibility of the intervention, the proportion of eligible women who enroll and complete the study will be examined.

  Baseline, 2 months

• Intervention: Acceptability

  To assess acceptability, participants will complete a measure of satisfaction that will include a closed question assessing their satisfaction with the virtual PN using a 5-point likert-scaled response category and an open-ended question concerning their likes and dislikes.

  2 months

Secondary Outcomes (2)

• Intervention: Changes in depressive symptoms

  Baseline, 1month, 2 months

• Intervention: Mental health treatment usage

  Baseline, 1 month, 2 months

Study Arms (2)

Qualitative phase

NO INTERVENTION

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 during the pandemic. This information will be used to adapt an evidence-based patient navigation intervention for virtual use.

Intervention Phase

EXPERIMENTAL

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.

Other: Virtual Navigator Program

Interventions

Virtual Navigator Program OTHER

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.

Intervention Phase

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Birth-mothers who experienced PPD symptoms
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

• Guevara JP, Morales K, Mandell D, Mogul M, Charidah T, Luethke M, Min J, Clark R, Betancourt L, Boyd R. Social Media-based Parenting Program for Women With Postpartum Depressive Symptoms: An RCT. Pediatrics. 2023 Mar 1;151(3):e2022058719. doi: 10.1542/peds.2022-058719.

  PMID: 36808207 BACKGROUND

MeSH Terms

Conditions

Depression, Postpartum; Psychological Well-Being

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• James Guevara, MD, MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Rhonda Boyd, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Guevara, MD, MPH

CONTACT

215-590-1130; guevara@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 (PPD) symptoms will be recruited to participate in the adapted virtual navigator program using rapid cycle testing over a 2-month period.

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 17, 2024
• Study Start: June 29, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after the end of the final year of funding.

Locations

US (1)