Substance Use Treatment and Access to Resources (STARS) Project

NCT04459000 | Recruiting

• 1 other identifier: STARSProj
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Use Disorders; Pregnancy Related; Child Neglect

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• Mother depressive symptoms

  Center for Epidemiological Studies Depression Screener score

  Change from baseline to 18 months post birth of child

• Child development

  Infant and Toddler Sensory Profile

  Change from baseline to 18 months post birth of child

• Child development

  Bayley Scales

  Change from baseline to 18 months post birth of child

• 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

• 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

Study Arms (3)

STARs Only

ACTIVE COMPARATOR

Consenting research participant who receive prenatal care services in the STAR clinic, but are not randomized to receive mABC home visiting services.

Behavioral: STARs Only

STARS + mABC

EXPERIMENTAL

Consenting research participant who receive prenatal care services in the STAR clinic, and are randomized to receive mABC home visiting services.

Behavioral: STARS + maternal Attachment Biobehavioral Catchup home visiting model

Control Group/CHOUM Only

NO INTERVENTION

These are research participants who were eligible to receive care in the STAR clinic, but did not opt to receive that care.

Interventions

STARS + maternal Attachment Biobehavioral Catchup home visiting model BEHAVIORAL

Mothers 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 + mABC

STARs Only BEHAVIORAL

Participants 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).

STARs Only

Eligibility Criteria

• Age: Up to 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• David Bard, PhD

  OUHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mallory Ford, MS

CONTACT

405-271-8858; mallory-ford@ouhsc.edu

Geneva Marshall, MS

CONTACT

4052718858; geneva-marshall@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor/research technician will not intentionally be made aware of the participant's treatment group, although this information may not be entirely possible to prevent the tech from learning.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2020
• First Posted: July 7, 2020
• Study Start: December 16, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)