Substance Use Treatment and Access to Resources (STARS) Project
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 55
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant woman with substance abuse issue occurring during pregnancy
Eligible for services at the STAR prenatal clinic
Speaks/comprehends English
Disqualifiers
Unable to read English at 8th grade comprehension level
Those outside of Oklahoma City metropolitan area.
Trial design
Design model
Parallel
Treatments tested in this trial
STARS + maternal Attachment Biobehavioral Catchup home visiting model
BehavioralMothers receive up to 12 home visits from a licensed therapist focused on attachment and positive parenting in substance exposed babies. This includes 1 prenatal home visit and up to 11 postnatal visits.
STARs Only
BehavioralParticipants receive prenatal care in the STAR clinic (a clinic specifically designed to support mothers with substance abuse who are at risk of losing their children to child welfare at birth).
Treatment groups
242 Participants
are divided into 3 treatment groupsGroup A: STARs OnlyActive comparator 1 intervention
Group B: STARS + mABCExperimental treatment 1 intervention
Group C: Control Group/CHOUM OnlyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Change from baseline to 18 months post birth of child2
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.
Time frame
Change from baseline to 18 months post birth of child3
Mother depressive symptoms
Center for Epidemiological Studies Depression Screener score
Time frame
Change from baseline to 18 months post birth of child4
Child development
Infant and Toddler Sensory Profile
Time frame
Change from baseline to 18 months post birth of childSponsors and contacts
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Source ClinicalTrials.gov