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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Substance Use Disorders; Child Neglect
• Intervention / Treatment: Behavioral: STARs Only; Behavioral: STARS + maternal Attachment Biobehavioral Catchup home visiting model

Detailed Description

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. The study will focus on the following specific aims:

A. Specific Aims

The Oklahoma Department of Mental Health and Substance Abuse Services (OKDMHSAS), in partnership with two clinics at Children's Hospital at OU Medicine (CHOUM) - the Substance use Treatment And Recovery (STAR) prenatal clinic and the A Better Chance Clinic (ABCC) for infant assessment and treatment - have developed the Substance use Treatment and Access to Resources and Supports (STARS) program for pregnant women who have a substance use issue. The STARS program focuses on women residing in Oklahoma County (OK co.) who, at the time of birth, are at risk of losing their infant to state custody care (child removal). The effectiveness of combined focal services provided by the STAR (prenatal care, substance use treatment supports and postpartum care) and the ABCC (assessment, evidence-based parent training) clinics will be the target of the study described herein. The overarching goal of the study is to evaluate the impact of these services on the well-being of and permanency outcomes for children and families affected by substance abuse. The study will also evaluate the quality of service implementation and the overall project's adherence to the following objectives:

Objective 1: Develop training and cross-training to increase the knowledge base of the medical, therapy, and child welfare. The key element of this objective is to increase the state's capacity to deliver collaborative and integrated services to serve children ages 0-3 and their families. The STARS will increase the health care and child welfare workforce's capacity by disseminating emerging and evidence-based services for substance-exposed newborns and Fetal Alcohol Spectrum Disorder. The ODMHSAS and OKDHS plan to enhance cross-systems interventions that bridge agencies at policy and practice levels by pursuing procedural and policy modifications and formalize agreements to implement targeted evidence-based training that will enhance the knowledge base of statewide substance use disorder treatment providers, child welfare and health care professionals. Because of the state and local infrastructure, the ODMHSAS has developed to date, key partnerships, and access to data, the program is well-positioned to focus on substance-exposed newborns and their families as Oklahoma continues to strengthen and expand the statewide service and workforce capacity.

Objective 2: Enhance the well-being of children, parents, and families; and improve safe and permanent caregiving relationships. The key element of this objective is to improve evidence-based practices to address attachment and bonding that will serve the mother and baby. To achieve this, the STARS program will collaborate with A Better Chance Clinic (ABCC) at OUHSC to implement modified maternal Attachment Biobehavioral Catchup (mABC) adaptation for pre and postnatal babies. mABC is an intervention adapted from an evidence-based intervention for children who have experienced adversity (e.g., neglect). This adapted intervention specifically targets the challenges of infants born to opioid-dependent mothers.

Objective 3: Improve retention in substance use treatment and successful completion of treatment for parents: STARS program will utilize an array of EBPs to improve treatment retention and encourage completion of treatment services. Treatment outcomes are increased by offering services to meet the parent's needs. Motivational Interviewing (MI), Community Reinforcement Approach (CRA), and Seeking Safety (SS) and Cognitive Process Therapy for trauma (CPT) will be utilized to address the treatment needs.

Objective 4: Facilitate the implementation, delivery, and effectiveness of prevention services and programs under the Family First Prevention Services Act of 2018 for at-risk families: Under Division E, Title VII - Family First Prevention Services Act, listed under Prevention Activities under Title IV-E, it allows title IV-E dollars to fund promising, supported, and well-supported mental health and substance abuse prevention and treatment provided by a qualified clinician, and in-home parent skill-based programs, for up to 12 months for candidates for foster care and for pregnant or parenting foster youth. ODMHSAS will develop memorandums of understandings, conducting multidisciplinary teams, and providing the evidence-based services that treat families that are at risk in compliance with this services act.

Objective 5: Decrease the number of out of home placements for children by enhancing the safety of children prior to delivery: ODMHSAS with collaboration with OKDHS will develop Plans of Safe Care prior to delivery. The STARS program will implement Wraparound services to connect families to resources to support the mother and baby after delivery to ensure they have a safe environment and lifestyle.

Objective 6: Decrease the number of out of home placements for children at risk: The STARS program will provide various services and supports prior to delivery of the baby. The program will offer prenatal care; Medication-Assisted Treatment (MAT) when applicable, substance use treatment through telehealth or in-person, peer recovery, housing and employment, and aftercare supports.

• Study Type: Interventional
• Enrollment (Estimated): 242
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mallory Ford, MS; Phone Number: 405-271-8858; Email: mallory-ford@ouhsc.edu
• Study Contact Backup: Name: Geneva Marshall, MS; Phone Number: 53421 4052718858; Email: geneva-marshall@ouhsc.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73117
      • Recruiting
      • University of Oklahoma Health Sciences Center
      • Contact: Mallory Ford; Phone Number: 405-271-8858; Email: mallory-ford@ouhsc.edu
      • Contact: Geneva marshall; Phone Number: 53421 405-2718858; Email: geneva-marshall@ouhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: STARs Only; 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; 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).
Experimental: STARS + mABC; 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; 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.
No Intervention: Control Group/CHOUM Only; These are research participants who were eligible to receive care in the STAR clinic, but did not opt to receive that care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: David Bard, PhD, OUHSC

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2020
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 12, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: STARSProj

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No