Pregnancy Related Clinical Trial
Official title:
Substance Use Treatment and Access to Resources (STARS) Project
This study is evaluating a randomized clinical trial and a quasi-experimental observational study combined. Pregnant women with substance abuse issues are referred to the Substance Use Treatment and Recovery (STAR) prenatal clinic, and those who consent to participate in the study will be randomized to the STAR + maternal Attachment Biobehavioral Catchup (mABC) home visiting model or to the STAR only treatment group. Those who opt out of receiving prenatal care at STAR will be recruited as a control group for the QED portion. Those randomized to STAR + mABC will receive additional supports from a licensed therapist, including up to 12 home visits focused on substance exposed babies and positive parenting.
Status | Recruiting |
Enrollment | 242 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 55 Years |
Eligibility | Inclusion Criteria: - Pregnant woman with substance abuse issue occurring during pregnancy - Eligible for services at the STAR prenatal clinic - Speaks/comprehends English Exclusion Criteria: - Unable to read English at 8th grade comprehension level - Those outside of Oklahoma City metropolitan area. |
Country | Name | City | State |
---|---|---|---|
United States | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
University of Oklahoma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mother substance use | Are there group differences in the rate of mother's substance use? Substance use measured using Addiction Severity Index (ASI) assessment self-report. Frequencies of use of different drugs will be monitored. | Change from baseline to 18 months post birth of child | |
Primary | Mother contraceptive use | Are there group differences in the rate of mother's contraceptive use? Substance use measured using risk and contraception items from Youth Risk Behavior Surveillance System survey. Frequencies will be monitored for change. | Change from baseline to 18 months post birth of child | |
Primary | Mother depressive symptoms | Center for Epidemiological Studies Depression Screener score | Change from baseline to 18 months post birth of child | |
Primary | Child development | Infant and Toddler Sensory Profile | Change from baseline to 18 months post birth of child | |
Primary | Child development | Bayley Scales | Change from baseline to 18 months post birth of child | |
Primary | Child welfare involvement | Are there group differences in the rate of child removals by protective services? Count of children removed using Child Welfare data. | Change from baseline to 18 months post birth of child | |
Primary | Child welfare reunifications | Are there group differences in the rate of child reunifications among participants who lose temporary custody at birth? Count of reunifications for those who lost custody at birth based on child welfare data. | Change from baseline to 18 months post birth of child |
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