STARS Project for Pregnant Women with Substance Use Disorders
This study, called the Substance Use Treatment and Access to Resources (STARS) Project, is for pregnant women who have substance use issues. It aims to see if extra support helps mothers and their babies. You would either receive care at the STAR clinic (which helps mothers with substance abuse at risk of losing their children) or receive STAR clinic care plus up to 12 home visits from a therapist. These home visits focus on positive parenting and attachment with substance-exposed babies. The study will look at changes in your substance use, use of contraception, and symptoms of depression over 18 months after your child is born. To join, you must be a pregnant woman with a substance abuse issue, eligible for the STAR clinic, and able to understand English. You must also live in the Oklahoma City area. The study plans to enroll 242 participants, but its current status is unclear.
- Study design
- This study combines a randomized clinical trial and an observational study. Participants will be randomly assigned to one of two groups, or may join an observational group if they opt out of STAR prenatal care.
- What's involved
- If you are in the STAR + maternal Attachment Biobehavioral Catchup (mABC) group, you will receive up to 12 home visits from a therapist, including one before birth and up to 11 after birth. All participants will be followed for 18 months after the birth of their child.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 18 months after the birth of their child to assess changes in substance use, contraceptive use, and depressive symptoms.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Substance Use Treatment and Access to Resources (STARS) Project
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- David Bard, PhD · PRINCIPAL_INVESTIGATOR · OUHSC
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Mother substance useChange from baseline to 18 months post birth of child
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.
- Mother contraceptive useChange from baseline to 18 months post birth of child
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.
- Mother depressive symptomsChange from baseline to 18 months post birth of child
Center for Epidemiological Studies Depression Screener score
- Child developmentChange from baseline to 18 months post birth of child
Infant and Toddler Sensory Profile
- Child developmentChange from baseline to 18 months post birth of child
Bayley Scales
- Child welfare involvementChange from baseline to 18 months post birth of child
Are there group differences in the rate of child removals by protective services? Count of children removed using Child Welfare data.
- Child welfare reunificationsChange from baseline to 18 months post birth of child
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.