Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The University of Texas at San Antonio | OTHER |
Not provided
Not provided
Not provided
This research activity looks at the safety of an investigational intervention, a mobile health (mHealth) app called JUN, that uses artificial intelligence (AI) to track symptoms and give time-sensitive feedback to pregnant women.
JUN is an intervention being developed to provide education and assist with decision making during pregnancy.
The researchers hope to learn differences in how effectively the participant use of the app is amongst women with and without criminal justice oversight such as adult probation or parole.
In this proposed pilot study, the investigators will use mixed methods to examine differences across three months among pregnant women. Sampling will be within three ethnically and geographically diverse sites, Texas, Oregon, and Minnesota to determine if there are differences in self-efficacy amongst pregnant women on Community Service (CS) compared to pregnant women without criminal justice oversight.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant without Criminal Justice Oversight | Experimental | Pregnant women who are without criminal justice oversight |
|
| Pregnant with Criminal Justice Oversight | Experimental | Pregnant women who are under Community Supervision (CS), on probation or parole with criminal justice oversight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jun mHealth app | Device | The intervention will be a mHealth app, JUN, across 3 months during pregnancy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self Rated Abilities for Health Practice (SRAHP) | The Self Rated Abilities for Health Practices Scale (SRAHP) is a 28-item, 5-point scale to measure self-perceived ability to implement health-promoting behaviors. SRAHP contains four subscales: Exercise, Nutrition, Responsible Health Practice, and Psychological Well Being. Each subscale has seven items. Respondents are asked to rate the extent to which they are able to perform health practices related to these four domains. An example of an item from the Health Practices subscale is "I am able to get help from others when I need it." Items are rated from 0 (not at all) to 4 (completely). Ratings for each subscale are summed to yield subscale scores. Subscale scores are summed to obtain a total score. Total scores range from 0-112. Higher scores indicate greater self-efficacy for health practices. | Baseline to Post-Intervention survey (approximately 3 months) |
| JUN mHealth app Timing | Timing of use of JUN app. | Month 1 to Month 3 |
| JUN mHealth app Frequency | Frequency of use of the JUN app | Month 1 to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Accountable Health Communities Health-Related Social Needs Screening (AHC HRSN) | There are five core domains of the AHC HRSN Screening Tool: (1) living situation, (2) food, (3) transportation, (4) utilities, and (5) safety. For each domain, if the participant answers yes to one of the items, it is a positive screen. There is not a total score for this measure. Rather, it assesses what participants have and do not have. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant women in their first 6 months of pregnancy
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Allison Ihle, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41921209 | Derived | Ihle AD, Wicks B, Metsis V, Starfall A, Clapham F, Gorbachev A, Shanley S, Strauser C, McGrath JM. Training an AI Chatbot to Manage Health in Underserved Populations: Methodological Approach. JMIR AI. 2026 Apr 1;5:e84145. doi: 10.2196/84145. |
Not provided
Not provided
No personally identifying data is anticipated to be recorded from human subjects, neither through survey responses or other interactions.
The PI, Co-PIs, researchers, and staff plan to make all data generated from this IIMS proposal freely available to the research community after publication. Through the freedom of information act, the data in the publications and the raw data documents will be made available upon written request to the laboratory. Should intellectual property be generated which requires a patent, we will ensure that the technology (materials and data) remains widely available to research community in accordance with the NIH Principles and Guidelines referenced above.
At the conclusion of this project's period, appropriate plans will be made to maintain data stored on UTHSCSA servers or otherwise upload it to a publicly-available repositor.
Not provided
Not provided
Not provided
1:1 selection of pregnant women with and without criminal justice oversight. There will be further random selection of a sub-sample (n=20) (n=10 with and n=10 without criminal justice oversight to interview using Health Belief Model (HBM)
Not provided
Not provided
Not provided
Not provided
|
| Baseline to Post-Intervention survey (approximately 3 months) |
| Sigma-Related Rejection Scale | A 9 item scale which uses multiple answer formats. The Stigma-Related Rejection Scale (SRS) (or its variations, like the Substance Abuse version) is a survey measuring interpersonal stigma and rejection experiences, with higher scores indicating greater perceived stigma and rejection. The SRS assesses the ongoing experiences of personal rejection related to enacted stigma, focusing on how individuals with mental health conditions or substance abuse problems perceive and experience stigma in their daily lives. Items are typically scored on a scale of 1 to 7, with higher scores indicating greater agreement with the statement and thus, higher levels of perceived rejection. | Baseline to Post-Intervention survey (approximately 3 months) |
| Abuse Assessment Screening tool (AAS) | This five-item tool detects abuse perpetrated against childbearing women with a sensitivity of 93%-94% and specificity of 55%-99% related to the question specific to abuse during pregnancy (e.g., "Since you were pregnant, have you been slapped, kicked, or otherwise physically hurt by someone," Within the past year, has anyone forced you to have sexual activities?"). Evidence: Women with SUD often live in potentially abusive or violent environments, which can negatively affect their perinatal health and may lead to a return to using illicit substances. Items 1 and 5 are answered yes/no; if items 2, 3, or 4 are answered yes, participant is asked to indicate category of abuser (Circle all that apply: husband, ex-husband, boyfriend, stranger, other, multiple); for items 2 and 3, participants are asked to mark the area of injury on a body map. For each violence incident, items are scored based on severity of (1-6)ǂ Cutoff for IPV: Affirmative response to ≥1 item(s) | Baseline to Post-Intervention survey (approximately 3 months) |
| Patient Health Questionnaire (PHQ) | Patient Health Questionnaire (PHQ2) measures the frequency and severity of depressed mood, anhedonia, and anxiety in the past weeks (e.g., "Over the last two weeks, how often have you been bothered by the following problems…feeling down, depressed, or hopeless?"). Responses are summed across items to yield a total score (e.g., cut-off scores >3 are considered elevated). PHQ-2 has 2 questions scored on a scale of 0-3 with a total score of 0-6. A score of 3 or higher indicates a need for further evaluation. | Baseline to Post-Intervention survey (approximately 3 months) |
| Generalized Anxiety Disorder (GAD2) | Patient Generalized Anxiety Disorder Survey (GAD2) measures the frequency and severity of depressed mood, anhedonia, and anxiety in the past weeks (e.g., "Over the last two weeks, how often have you been bothered by the following problems…feeling down, depressed, or hopeless?"). Responses are summed across items to yield a total score (e.g., cut-off scores >3 are considered elevated). GAD-2 has 2 questions scored on a scale of 0-3 with a total score of 0-6. A score of 3 or higher needs further diagnostic evaluation | Baseline to Post-Intervention survey (approximately 3 months) |