Virtual Patient Navigation During a Pandemic

Post-partum Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208852
• Other study ID #: 19-016174-B
• Secondary ID: R61MH11840519-01
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2023
• Est. completion date: November 18, 2025

Study information

• Verified date: January 2024
• Source: Children's Hospital of Philadelphia
• Contact: James Guevara, MD, MPH
• Phone: 215-590-1130
• Email: guevara[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and an engagement measure. 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.

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R61 Phase (IRB 19-016174) of the Main Randomized Clinical Trial (RCT), or have been referred, are actively enrolled, or withdrawn in the R33 Phase (IRB 22-019784) of the Main RCT, will be recruited to participate in semi-structured interviews. In the intervention phase of the sub-study, 30 eligible women who are either former participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, enrolled but completed participation, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT, but not actively engaged with mental health services, will be enrolled and consented to receive virtual patient navigation for 2 months. The qualitative phase will involve audio-recorded semi-structured interviews to identify barriers and facilitators to virtual and in-person mental health services. These interviews will then inform the intervention phase which involves the adaptation of an existing mental health navigation intervention for a virtual environment and a measure of mental health engagement. For both phases of the sub-study, those who agree to participate will be asked to verbally agree to the approved HIPAA form and sign the informed consent form.

For the qualitative phase of the sub-study, 10 eligible women will participate in a 30-40 minute semi-structured interview. Following written informed consent, the participating mother will then participate in a 30-40 minute semi-structured interview. The interview will consist of questions regarding barriers and facilitators to accessing mental health services during a pandemic. The interviews will be audiotaped and transcribed. In the event that the interview cannot be completed in person, a research staff member will complete the interview over the phone with the participant. Transcripts of interviews will be reviewed by 2-3 investigators. Transcripts will be coded and emergent themes related to barriers and facilitators to virtual navigation will be identified using inductive means. Initial codes will be developed inductively through consensus of the investigative team. Themes pertaining to child and family factors and benefits and barriers to mental health service use in a virtual environment will be identified. Investigators will use NVivo, a qualitative software program, to facilitate coding of transcripts and identification of themes. This information will be used to adapt an evidence-based patient navigation intervention for virtual use. Investigators will also use information from this qualitative study to adapt a measure of engagement in early intervention services for use among women with postpartum depression to measure engagement with mental health services.

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. These women will be enrolled and consented to receive virtual patient navigation for 2 months. Investigators will conduct rapid cycle testing in which the investigators 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 patient navigator by means of telephone, text messaging, Facetime, or other virtual modality of their choice. The patient navigator will meet with families at the beginning of the study to review results of depression screens and community mental health resources. The patient navigator will partner with participants, engage them in the program, and provide ongoing communication with participants and mental health clinicians. The patient navigator will contact participants weekly by phone, text messaging, email, or any other modality depending on participant preference to monitor initiation and completion of referral, identify concerns and/or barriers to referral completion, and assist participants with problem-solving to identify potential barriers and solutions to complete mental health referrals. Specific barriers and proposed solutions will be identified in the qualitative study above. Using virtual means, the patient navigator will also communicate with mental health clinicians to clarify appointments and address emerging issues. A fidelity checklist will be adapted to assess self-reported task completion by the patient navigator (0- not completed, 1- partially completed, 2- fully completed).

All participants will be monitored monthly for depressive symptoms and suicidality. Those who report worsening depressive symptoms (EPDS>20) or suicidality (affirmative response to Question #10 on the EPDS) will be contacted immediately by study staff and an existing suicide protocol from the parent study will be initiated.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 18, 2025
• Est. primary completion date: November 18, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Qualitative Phase:

Women who:

1. 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.

2. Are > 18 years of age

3. Speak and read in English

4. Have access to a smart phone or computer tablet with internet access

5. Have an infant < 12 months of age

Intervention Phase:

Women who:

1. Are either former participants from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, enrolled but completed participation, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT.

2. Are not actively engaged with MH services

3. Are > 18 years of age

4. Speak and read in English

5. Have access to a smart phone or computer tablet with internet access

6. Have an infant < 12 months of age

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Post-partum Depression

Intervention

Other:
• Virtual 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

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention: Changes in mental health engagement	The Attention-Deficit/Hyperactivity Disorder (ADHD) Engagement Scale (AES) will be adapted for use with Mental Health services by women with postpartum depression. The AES is a 28-item scale that was developed to assess engagement with ADHD care by families and contains 4 subscales: access, patient and family centered care, communication, and understanding. Response categories for the AES are 4-point Likert-scaled ranging from "Not at All/Little Bit" to "Very Much". The AES demonstrates good content validity and excellent internal consistency with Cronbach Alpha values ranging from 0.86 to 0.93.25. The total score will be used.	Baseline, 2 months.
Primary	Qualitative: Barriers and facilitators to virtual and in-person mental health services	Participants will be audio-recorded while participating in a semi-structured one-on-one interview with a study team member.	Baseline
Secondary	Intervention: Changes in depressive symptoms	Depressive symptoms and outside mental health treatment will be measured monthly using the Edinburgh Postnatal Depression Scale (EPDS).The EPDS is a validated 10-item self-report measure of depressive symptoms with strong evidence for reliability, validity, and utility in varying populations. It has been used extensively in mental health research and provides cutpoints to determine the severity of depressive symptoms. It includes a question on suicidal thoughts and wishes (#10) that will be used to monitor for suicidality. The total score will be used with scores of 10 or higher representing minor or moderate depression and scores of 20 or greater representing severe depression.	Baseline, 2 months
Secondary	Intervention: Changes in mental health service use	Outside mental health treatment will be measured monthly using the item from the National Comorbidity Survey (NCS) concerning any mental health service use.	Baseline, 2 months
Secondary	Intervention: Changes in perceived social support	The Multi-dimensional Scale of Perceived Social Support (MSPSS) is a 12-item scale that assesses perceived social support from family, friends, and a significant other. Response categories are on a 7-point likert-scale from very strongly disagree to very strongly agree. The total score will be used.	Baseline, 2 months
Secondary	Intervention: Satisfaction with the virtual patient navigator	The Satisfaction survey 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. The total score will be used and the open ended question will be qualitatively analyzed to help inform the satisfaction scores.	2 months