Trial Outcomes & Findings for Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care (NCT NCT05423093)
NCT ID: NCT05423093
Last Updated: 2025-09-03
Results Overview
Completed by parent participants. 5-point likert scale from 1 (strongly disagree) to 5 (strongly agree), higher scores indicative of higher satisfaction. No established cutoff.
COMPLETED
NA
26 participants
Within 2 weeks of attending video group session
2025-09-03
Participant Flow
Participant milestones
| Measure |
Intervention Delivery
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Consented Participants - Baseline Comple
STARTED
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26
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Consented Participants - Baseline Comple
COMPLETED
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22
|
|
Consented Participants - Baseline Comple
NOT COMPLETED
|
4
|
|
Attended Intervention Session
STARTED
|
22
|
|
Attended Intervention Session
COMPLETED
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19
|
|
Attended Intervention Session
NOT COMPLETED
|
3
|
|
Completed Post-intervention Measures
STARTED
|
19
|
|
Completed Post-intervention Measures
COMPLETED
|
16
|
|
Completed Post-intervention Measures
NOT COMPLETED
|
3
|
|
6-month Post Intervention Data Collected
STARTED
|
16
|
|
6-month Post Intervention Data Collected
COMPLETED
|
14
|
|
6-month Post Intervention Data Collected
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Intervention Delivery
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Consented Participants - Baseline Comple
Lost to Follow-up
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2
|
|
Consented Participants - Baseline Comple
Withdrawal by Subject
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2
|
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Attended Intervention Session
Lost to Follow-up
|
3
|
|
Completed Post-intervention Measures
Lost to Follow-up
|
3
|
|
6-month Post Intervention Data Collected
Lost to Follow-up
|
2
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Baseline Characteristics
Virtual Group Psychoeducational Discussions With Spanish-Speaking Mothers of Infants in Pediatric Primary Care
Baseline characteristics by cohort
| Measure |
Intervention Delivery
n=22 Participants
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Age, Continuous
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32.6 years
STANDARD_DEVIATION 6.5 • n=99 Participants
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Sex: Female, Male
Female
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22 Participants
n=99 Participants
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Sex: Female, Male
Male
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0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · White, Hispanic
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9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Multiracial, Hispanic
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1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Black
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0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Other, Hispanic
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12 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian/Alaska Native
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0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race · Asian/Pacific Islander
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0 Participants
n=99 Participants
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Region of Enrollment
United States
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22 Participants
n=99 Participants
|
|
Country of origin
El Salvador
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6 Participants
n=99 Participants
|
|
Country of origin
Guatemala
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3 Participants
n=99 Participants
|
|
Country of origin
Honduras
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6 Participants
n=99 Participants
|
|
Country of origin
Ecuador
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2 Participants
n=99 Participants
|
|
Country of origin
Mexico
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5 Participants
n=99 Participants
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|
Maternal Education
8th grade or less
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14 Participants
n=99 Participants
|
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Maternal Education
Some high school
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3 Participants
n=99 Participants
|
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Maternal Education
High school or greater
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5 Participants
n=99 Participants
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|
Time in United States
|
11.5 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
|
Ever had mental health treatment
Yes
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6 Participants
n=99 Participants
|
|
Ever had mental health treatment
No
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16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Within 2 weeks of attending video group sessionPopulation: Participants who completed the survey are reported
Completed by parent participants. 5-point likert scale from 1 (strongly disagree) to 5 (strongly agree), higher scores indicative of higher satisfaction. No established cutoff.
Outcome measures
| Measure |
Intervention Delivery
n=16 Participants
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Satisfaction as Assessed by the Intervention Satisfaction Survey
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4.06 score on a scale
Standard Deviation 0.63
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PRIMARY outcome
Timeframe: Within 2 weeks of attending video group sessionPopulation: Participants who completed the survey are reported
Completed by parent participants. 4-question pragmatic measure designed to assess construct of intervention acceptability as perceived by participant. 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Higher scores indicate greater acceptability. Score for each participant calculated as mean score for each item (range 1-5)
Outcome measures
| Measure |
Intervention Delivery
n=16 Participants
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Acceptability of Intervention Measure
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4.17 units on a scale
Interval 4.0 to 5.0
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SECONDARY outcome
Timeframe: Baseline (pre-session); within 2 weeks post-sessionPopulation: Participants who completed both pre and post-intervention survey are reported
Completed by parent participants. The SCMHC is a 3-item measure assessing stigma-related barriers to the utilization of depression treatment (internalized stigma, fear of stigmatization, and stigma from family in seeking mental health care). Responses are coded as (0) disagree, (1) agree, and (7) don't know/refuse. Respondents receive one point for each response of "agree," which indicates agreement with the stigma-related barrier. The total scores range from 0 to 3 with higher scores indicating an increased internalization of stigma to mental health care
Outcome measures
| Measure |
Intervention Delivery
n=16 Participants
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Pre-Post Intervention Change in Mental Health Care Stigma as Assessed by the Stigma Concerns About Mental Health Care (SCMHC) Scale
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-0.49 score on a scale
Standard Deviation 0.97
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SECONDARY outcome
Timeframe: Baseline (pre-session); within 2 weeks post-sessionPopulation: Participants who completed both pre and post-intervention surveys are reported
7 items, assess personal attitudes towards people with depression. Items answered on 5-point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). Calculated as average item score, higher scores indicate higher levels of depression stigma.
Outcome measures
| Measure |
Intervention Delivery
n=16 Participants
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Change in Depression Stigma as Assessed by the Adapted Personal Stigma Scale (PSS)
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-0.27 score on a scale
Standard Deviation 0.31
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SECONDARY outcome
Timeframe: Completed by participants at baseline (pre-session); within 2 weeks post-session; 6 months post sessionPopulation: 22 participants completed this measure at baseline; 16 participants completed this measure 2 weeks post intervention; and 14 completed 6 months post intervention.
Measure of participant knowledge about postpartum depression knowledge- adapted and translated from the Ontario Rapid Risk Factor Surveillance Survey. Questions include whether the participant has heard of the concept of postpartum depression, asks participants to name symptoms of postpartum depression, and asks participants how common they would estimate the condition to be. There is no standard scale/scoring. Percent of participants answering affirmatively to the question "Have you heard of postpartum depression?" is reported.
Outcome measures
| Measure |
Intervention Delivery
n=22 Participants
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure
No - Within 2 Weeks Post-session
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1 participants
|
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Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure
Yes - 6 Months Post-session
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11 participants
|
|
Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure
No - 6 Months Post-session
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3 participants
|
|
Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure
Yes - Baseline/Pre-session
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14 participants
|
|
Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure
No - Baseline/Pre-session
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8 participants
|
|
Postpartum Depression Knowledge as Assessed by Adapted Postpartum Depression Knowledge Measure
Yes - Within 2 weeks Post-session
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15 participants
|
SECONDARY outcome
Timeframe: Baseline (pre-session); within 2 weeks post-session; and 6 months post-sessionPopulation: 22 completed at baseline, 16 completed post-intervention, 14 completed at 6-month follow up
Completed by parent participants. Single-question item: If I felt down, depressed, hopeless, or having little interest or pleasure in doing things I would try to contact someone at this clinic. Response options were No or Yes.
Outcome measures
| Measure |
Intervention Delivery
n=22 Participants
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire
Pre-intervention · Yes
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22 Participants
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Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire
Pre-intervention · No
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0 Participants
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Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire
Post-Intervention · Yes
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15 Participants
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Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire
Post-Intervention · No
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1 Participants
|
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Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire
6-month post intervention · Yes
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14 Participants
|
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Intention to Disclose if Developed Postpartum Depression Symptoms as Assessed by Questionnaire
6-month post intervention · No
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0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Within 2 weeks of attending video group session, 6 months post interventionPopulation: This question was only asked of participants who indicated not having a primary care provider at baseline, since it is about intention to identify/obtain a primary care provider in the future (so is not relevant to those who already have a primary care provider). Due to a technical error, the survey was inadvertently only administered to 6 of the 16 participants who completed 2 week post-intervention survey. It was administered to 14 participants 6-mo post intervention
Developed for this study, single likert scale question asked of participants who did not have an identified primary care doctor: As a result of the video group session, I plan to identify a doctor that I can see regularly for my own check-ups. Adapted from National Latino and Asian American Study. Scale range from 1-5, 1= strongly agree; 2=agree; 3=neutral/no opinion, 4=disagree, 5=strongly disagree
Outcome measures
| Measure |
Intervention Delivery
n=14 Participants
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Intention to Seek Primary Care as Assessed by Survey Question
Baseline
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2.71 score on a scale
Standard Deviation 1.03
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Intention to Seek Primary Care as Assessed by Survey Question
Post-intervention (within 2 weeks post intervention)
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1.83 score on a scale
Standard Deviation 0.37
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Intention to Seek Primary Care as Assessed by Survey Question
6-months post intervention
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2.07 score on a scale
Standard Deviation 0.35
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SECONDARY outcome
Timeframe: 6 months post-interventionPopulation: Participants who completed the 6-month post-intervention survey included in the analysis
Single item, adapted from National Latino and Asian American Study; question: "within the past 6 months, have you had a therapy session with a psychologist or therapist or another professional that lasted 30 minutes or longer"?. Response options included "Yes", "No", "Unsure", and "Prefer Not to Answer".
Outcome measures
| Measure |
Intervention Delivery
n=14 Participants
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Self-reported Mental Health Service Utilization Within the Past 6 Months
Yes
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2 Participants
|
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Self-reported Mental Health Service Utilization Within the Past 6 Months
No
|
12 Participants
|
|
Self-reported Mental Health Service Utilization Within the Past 6 Months
Unsure
|
0 Participants
|
|
Self-reported Mental Health Service Utilization Within the Past 6 Months
Prefer not to answer
|
0 Participants
|
SECONDARY outcome
Timeframe: 6-months post-interventionPopulation: colleted from those who completed 6 month follow up survey (N=14)
Completed by participant. Question developed for this project and translated/certified, assessing use of clinic ancillary services discussed in the intervention: In the past 2 months, have you used any of the resources that were discussed in the video session or on the clinic website? Responses could include "Yes", "No", or "Unsure"
Outcome measures
| Measure |
Intervention Delivery
n=14 Participants
Participants will receive a 45-60 minute single-session video group psychoeducational intervention delivered by clinic staff.
Single-Session Virtual Group Psychoeducational Session about Postpartum Depression: Session contents include (1) Introduction to clinic staff, contacts, and resources (2) A video-recorded testimonial of a patient with a history of perinatal depression followed by a group discussion about/reflection on the video; (3) Review of prevalence and signs of PPD; (4) Discussion of clinic PPD screening procedures and rationale for screening; (5) Discussion of self-care and mood monitoring; (6) Discussion of relevant local resources, including information about availability of primary care resources for parents (including uninsured parents) and information about resources addressing social needs.
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|---|---|
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Psychosocial Resource Utilization as Assessed by Questionnaire
Yes
|
4 Participants
|
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Psychosocial Resource Utilization as Assessed by Questionnaire
No
|
9 Participants
|
|
Psychosocial Resource Utilization as Assessed by Questionnaire
Unsure
|
1 Participants
|
Adverse Events
Intervention Delivery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place