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.

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NCT04459000

Substance Use Treatment and Access to Resources (STARS) Project

Recruiting
NAUp to 55InterventionalSupportive care
University of Oklahoma
~242 participants
Updated 2024-10-31 on ClinicalTrials.gov
What's tested:STARS + maternal Attachment Biobehavioral Catchup home visiting modelSTARs Only

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mother substance use
Measured over Change from baseline to 18 months post birth of child
+6 more outcomes measured
Substance Use Disorders
Pregnancy Related
Child Neglect
1 sites across 1 states
Oklahoma1
  • David Bard, PhD · PRINCIPAL_INVESTIGATOR · OUHSC

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Eligibility criteria

Inclusion

Pregnant woman with substance abuse issue occurring during pregnancy
Eligible for services at the STAR prenatal clinic
Speaks/comprehends English

Exclusion

Unable to read English at 8th grade comprehension level
Those outside of Oklahoma City metropolitan area.
  • 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.