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STARS + Maternal Support for Substance Use During Pregnancy

N/A
Recruiting
Led By David Bard, PhD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 18 months post birth of child
Awards & highlights

Study Summary

This trial is testing a new program for pregnant women with substance abuse issues, which includes additional support from a licensed therapist.

Who is the study for?
This trial is for pregnant women in the Oklahoma City area who are dealing with substance abuse during pregnancy, can understand English, and are eligible for services at the STAR prenatal clinic. Women must be able to read English at an 8th-grade level or higher to participate.Check my eligibility
What is being tested?
The STARS Project is testing two approaches: one group receives standard treatment (STARs Only), while another gets additional support through a home visiting model called mABC that focuses on caring for babies exposed to substances and enhancing parenting skills.See study design
What are the potential side effects?
Since this study involves therapy and educational interventions rather than medications, traditional side effects like those seen with drugs aren't expected. However, participants may experience emotional discomfort discussing sensitive topics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 18 months post birth of child
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 18 months post birth of child for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child development
Child welfare involvement
Child welfare reunifications
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: STARS + mABCExperimental Treatment1 Intervention
Consenting research participant who receive prenatal care services in the STAR clinic, and are randomized to receive mABC home visiting services.
Group II: Control Group/CHOUM OnlyActive Control1 Intervention
These are research participants who were eligible to receive care in the STAR clinic, but did not opt to receive that care.
Group III: STARs OnlyActive Control1 Intervention
Consenting research participant who receive prenatal care services in the STAR clinic, but are not randomized to receive mABC home visiting services.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
95,681 Total Patients Enrolled
David Bard, PhDPrincipal InvestigatorOUHSC
1 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

STARS + maternal Attachment Biobehavioral Catchup home visiting model Clinical Trial Eligibility Overview. Trial Name: NCT04459000 — N/A
Substance Use Disorder Research Study Groups: Control Group/CHOUM Only, STARs Only, STARS + mABC
Substance Use Disorder Clinical Trial 2023: STARS + maternal Attachment Biobehavioral Catchup home visiting model Highlights & Side Effects. Trial Name: NCT04459000 — N/A
STARS + maternal Attachment Biobehavioral Catchup home visiting model 2023 Treatment Timeline for Medical Study. Trial Name: NCT04459000 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial currently have openings for participants?

"According to the data on clinicaltrials.gov, this research initiative is in search of more patients. The trial's original launch date was December 16th 2020 and its most recent update came on January 8th 2021."

Answered by AI

What is the current tally of individuals involved in this research endeavor?

"Indeed, clinicaltrials.gov provides evidence that this trial is still recruiting participants. This clinical study was first posted on December 16th 2020 and the details were most recently updated on January 8th 2021. As of now, 242 participants are being sought out from a single medical center."

Answered by AI

Who else is applying?

What state do they live in?
Oklahoma
How old are they?
18 - 65
What site did they apply to?
University of Oklahoma Health Sciences Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Substance Use Treatment and Access to Resources (STARS) Project
2020. "Substance Use Treatment and Access to Resources (STARS) Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04459000.
~27 spots leftby Sep 2024
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