Clinical trial NCT06636110: Piloting JUN_Pregnancy Mobile Medical App
Official title: Piloting of JUN to Enhance Self-Efficacy Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Pregnancy
Keywords: Community Supervision
Criminal Justice Oversight
Jun App
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: The University of Texas at San Antonio
First posted: 2024-10-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Pregnant female 18-50 years
2. Within first 6 months of pregnancy
3. Either on community supervision or without criminal system involvement
4. Located in Texas, Minnesota or Oregon

Exclusion Criteria:

1. Individuals who do not identify as women
2. Later pregnancy, beyond the first 6 months

Primary outcomes:
measure: Self Rated Abilities for Health Practice (SRAHP)
timeFrame: Baseline to Post-Intervention survey (approximately 3 months)
measure: JUN mHealth app Timing
timeFrame: Month 1 to Month 3
measure: JUN mHealth app Frequency
timeFrame: Month 1 to Month 3
Secondary outcomes:
measure: Accountable Health Communities Health-Related Social Needs Screening (AHC HRSN)
timeFrame: Baseline to Post-Intervention survey (approximately 3 months)
measure: Sigma-Related Rejection Scale
timeFrame: Baseline to Post-Intervention survey (approximately 3 months)
measure: Abuse Assessment Screening tool (AAS)
timeFrame: Baseline to Post-Intervention survey (approximately 3 months)
measure: Patient Health Questionnaire (PHQ)
timeFrame: Baseline to Post-Intervention survey (approximately 3 months)
measure: Generalized Anxiety Disorder (GAD2)
timeFrame: Baseline to Post-Intervention survey (approximately 3 months)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Allison Crawford, PhD
role: PRINCIPAL_INVESTIGATOR
References: