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Substance Use DisordersNCT04459000

Substance Use Treatment and Access to Resources (STARS) Project

A study testing STARS + maternal Attachment Biobehavioral Catchup home visiting model and STARs Only in people with Substance Use Disorders and Pregnancy Related, run by University of Oklahoma at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 +… Read more about this study

Who is it for?
Ages Up to 55 years
What is being tested?
STARS + maternal Attachment Biobehavioral Catchup home visiting model and STARs Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
242 participants
Where
1 siteUnited States
Study dates
16 Dec 2020to Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 55 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73117

    Mallory Ford, 405-271-8858, mallory-ford@ouhsc.edu

    Geneva marshall, 405-2718858 ext. 53421, geneva-marshall@ouhsc.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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:

  1. 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.

Being tested
STARS + maternal Attachment Biobehavioral Catchup home visiting model, STARs Only
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STARS + maternal Attachment Biobehavioral Catchup home visiting modelBehavioural

    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 OnlyBehavioural

    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).

Study groups in NCT04459000
Study groupRoleWhat they receive
STARs OnlyActive comparatorConsenting research participant who receive prenatal care services in the STAR clinic, but are not randomized to receive mABC home visiting services.
Receives: Behavioral: STARs Only
STARS + mABCExperimentalConsenting research participant who receive prenatal care services in the STAR clinic, and are randomized to receive mABC home visiting services.
Receives: Behavioral: STARS + maternal Attachment Biobehavioral Catchup home visiting model
Control Group/CHOUM OnlyNo interventionThese are research participants who were eligible to receive care in the STAR clinic, but did not opt to receive that care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from baseline to 18 months post birth of child

  2. 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.

    Measured: Change from baseline to 18 months post birth of child

  3. Mother depressive symptoms

    Center for Epidemiological Studies Depression Screener score

    Measured: Change from baseline to 18 months post birth of child

  4. Child development

    Infant and Toddler Sensory Profile

    Measured: Change from baseline to 18 months post birth of child

  5. Child development

    Bayley Scales

    Measured: Change from baseline to 18 months post birth of child

  6. Child welfare involvement

    Are there group differences in the rate of child removals by protective services? Count of children removed using Child Welfare data.

    Measured: Change from baseline to 18 months post birth of child

  7. 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.

    Measured: Change from baseline to 18 months post birth of child

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2020
  2. Study start16 Dec 2020
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
242 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04459000
Sponsor's protocol ID
STARSProj
Status last verified
Oct 2024
First submitted
12 Jun 2020
Last updated
31 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing STARS + maternal Attachment Biobehavioral Catchup home visiting model and STARs Only in people with Substance Use Disorders and Pregnancy Related, run by University of Oklahoma at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mallory Ford, MS (405-271-8858, mallory-ford@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mother substance use (time frame: Change from baseline to 18 months post birth of child). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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