Clinical trial NCT06208852: Virtual Patient Navigation During a Pandemic
Official title: The Social Media-Based Parenting Program for Women With Postpartum Depressive Symptoms: Virtual Patient Navigation During a Pandemic
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-partum Depression
Keywords: post-partum depression
mental health
child and maternal health
patient navigator
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-01-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: SCREENING

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.

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R61 Phase (IRB 19-016174) of the Main Randomized Clinical Trial (RCT), or have been referred, are actively enrolled, or withdrawn in the R33 Phase (IRB 22-019784) of the Main RCT, will be recruited to participate in semi-structured interviews.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. 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.

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.

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.

Eligibility criteria: Inclusion Criteria

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 not actively engaged with MH services
2. Screen positive for postpartum depression (score\>9) on the EPDS
3. Are \> 18 years of age
4. Speak and read in English
5. Have access to a cellular phone with texting capabilities

Exclusion Criteria

Qualitative Phase:

Women who:

1. Report suicidality (i.e., suicidal ideation and/or behavior) on the EPDS (Question #10) at enrollment.
2. Report severe depressive symptoms (EPDS\>20) at enrollment.
3. Have a substantiated report of child maltreatment

Children who:

1. Were born premature (estimated gestational age\<35 weeks)
2. Have been diagnosed with congenital malformations or genetic syndromes which place them at risk of developmental delays
3. Are already currently receiving early intervention services for developmental delays at baseline

Intervention Phase:

Women who:

1. 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
2. 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?
3. Have a substantiated report of child maltreatment

Primary outcomes:
measure: Qualitative: Barriers and facilitators to virtual and in-person mental health services
timeFrame: Baseline
measure: Intervention: Target engagement of the Patient Navigator
timeFrame: Baseline, 2 months.
measure: Intervention: Feasibility
timeFrame: Baseline, 2 months
measure: Intervention: Acceptability
timeFrame: 2 months
Secondary outcomes:
measure: Intervention: Changes in depressive symptoms
timeFrame: Baseline, 1month, 2 months
measure: Intervention: Mental health treatment usage
timeFrame: Baseline, 1 month, 2 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: James Guevara, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Rhonda Boyd, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.