Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05718479
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2022-12-01
Brief Title:
Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity A Pilot Randomized Controlled Trial of Motivational Interviewing and Mental Wellness Skills
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention TPI in pregnant Black women with childhood adversity TPI participants will receive four weekly individual virtual sessions of motivational interviewing to promote self-efficacy and mental wellness skills to enhance self-awareness and self-regulation TPI is designed to foster behavior change and health coping by enhancing knowledge beliefs regulation skills and abilities
With the assistance of a trained facilitator participants will be guided to identify a specific goal related to the behavior they want to change
Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping accountability and self-care rewards
Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire motivation and individual responses to stress
Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological eg depression anxiety and perceived stress and socio-emotional eg mood resilience social support and prenatal health behaviors
With the assistance of a trained facilitator participants will be guided to identify a specific goal related to the behavior they want to change
Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping accountability and self-care rewards
Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire motivation and individual responses to stress
Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological eg depression anxiety and perceived stress and socio-emotional eg mood resilience social support and prenatal health behaviors
Detailed Description:
The goal of this research to reduce the impact of maternal adverse childhood experiences ACEs on perinatal mental and psychosocial health by providing the necessary tools for the development of healthy coping practices The purpose of this proposal is to conduct Phase II preliminary testing of an individually randomized pilot trial N40 examining feasibility acceptability and compare initial estimates of the effects of the primary outcome of depression and secondary outcomes of psychological eg stress and anxiety and socio-emotional eg mood resilience social support functioning and prenatal health behaviors of those allocated to either a trauma-informed prenatal intervention TPI n15 or the control group eg prenatal education arm n15 Forty adult pregnant women receiving prenatal care at one large Federally Qualified Health Center will be enrolled between 10-24 weeks gestation TPI participants will receive four weekly 30-60 minute individual online sessions of motivational interviewing to facilitate behavior change and mental wellness skills to promote self-regulation Control group participants will receive four weekly 30-60 minutes individual online sessions of prenatal education Patient-reported outcome measures will be interview-administered at baseline 4- and 12-weeks post-randomization and 6-weeks postpartum A trauma-informed approach within prenatal care services may help reduce maternal distress and its consequences and subsequently lessen the risk for the negative impact of ACEs on maternal and child health Findings from this study will inform a larger efficacy trial of TPI to improve perinatal mental health among pregnant women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U54MD012523 | NIH | None | httpsreporternihgovquickSearchU54MD012523 |