- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06208852
Virtual Patient Navigation During a Pandemic
The Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Virtual Patient Navigation During a Pandemic
Study Overview
Status
Conditions
Intervention / Treatment
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R61 Phase (IRB 19-016174) of the Main Randomized Clinical Trial (RCT), or have been referred, are actively enrolled, or withdrawn in the R33 Phase (IRB 22-019784) of the Main RCT, will be recruited to participate in semi-structured interviews.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from the R61 Phase (IRB 19-016174) of the Main RCT, or have been referred, enrolled but completed participation, or withdrawn from the R33 Phase (IRB 22-019784) of the Main RCT, but not actively engaged with mental health services, will be enrolled and consented to receive virtual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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: James Guevara, MD, MPH
- Phone Number: 215-590-1130
- Email: guevara@chop.edu
Study Contact Backup
- Name: Michelle Reece, MPH
- Phone Number: 267-315-7552
- Email: reecem@chop.edu
Study Locations
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-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Children's Hospital of Philadelphia
-
Contact:
- James Guevara, MD, MPH
- Phone Number: 215-590-1130
- Email: guevara@chop.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 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.
- Are not actively engaged with MH services
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Qualitative phase
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.
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.
|
|
Experimental: Intervention Phase
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention: Changes in mental health engagement
Time Frame: Baseline, 2 months.
|
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.
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Baseline, 2 months.
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Qualitative: Barriers and facilitators to virtual and in-person mental health services
Time Frame: Baseline
|
Participants will be audio-recorded while participating in a semi-structured one-on-one interview with a study team member.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intervention: Changes in depressive symptoms
Time Frame: Baseline, 2 months
|
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.
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Baseline, 2 months
|
Intervention: Changes in mental health service use
Time Frame: Baseline, 2 months
|
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
|
Intervention: Changes in perceived social support
Time Frame: Baseline, 2 months
|
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.
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Baseline, 2 months
|
Intervention: Satisfaction with the virtual patient navigator
Time Frame: 2 months
|
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.
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2 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Rhonda Boyd, PhD, Children's Hospital of Philadelphia
- Principal Investigator: James Guevara, MD, MPH, Children's Hospital of Philadelphia
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-016174-B (Children's Hospital of Philadelphia)
- 19-016174 (Other Identifier: CHOP)
- R61MH118405 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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