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.
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
- Conditions the study is for
- Substance Use Disorders, Pregnancy Related, Child Neglect
- What is being tested?
- STARS + maternal Attachment Biobehavioral Catchup home visiting model and STARs Only
- Type of treatment
- Lifestyle or therapy programme
- 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
- 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
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:
- 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.
- Conditions
- Substance Use Disorders, Pregnancy Related, Child Neglect
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Mother depressive symptoms
Center for Epidemiological Studies Depression Screener score
Measured: Change from baseline to 18 months post birth of child
Child development
Infant and Toddler Sensory Profile
Measured: Change from baseline to 18 months post birth of child
Child development
Bayley Scales
Measured: 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.
Measured: 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.
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.
- First posted7 Jul 2020
- Study start16 Dec 2020
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Bard, PhD, Principal investigator, OUHSC
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
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substance Use Treatment and Access to Resources (STARS) Project
- ClinicalTrials.gov ID
- NCT04459000
- Acronym / sponsor ID
- STARSProj
- Conditions
- Substance Use Disorders, Pregnancy Related, Child Neglect
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| STARs Only | Active comparator | Behavioral: STARs OnlyConsenting research participant who receive prenatal care services in the STAR clinic, but are not randomized to receive mABC home visiting services. |
| STARS + mABC | Experimental | Behavioral: STARS + maternal Attachment Biobehavioral Catchup home visiting modelConsenting research participant who receive prenatal care services in the STAR clinic, and are randomized to receive mABC home visiting services. |
| 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. |
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnant woman with substance abuse issue occurring during pregnancy
- Eligible for services at the STAR prenatal clinic
- Speaks/comprehends English
Key exclusion criteria (2 listed)
- Unable to read English at 8th grade comprehension level
- Those outside of Oklahoma City metropolitan area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STARS + maternal Attachment Biobehavioral Catchup home visiting modelMothers 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. | Behavioural | STARS + mABC |
| STARs OnlyParticipants 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). | Behavioural | STARs Only |
Primary outcome
Mother substance use
Time frame: Change 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 use
Time frame: Change 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 symptoms
Time frame: Change from baseline to 18 months post birth of child
Center for Epidemiological Studies Depression Screener score
Child development
Time frame: Change from baseline to 18 months post birth of child
Infant and Toddler Sensory Profile
Child development
Time frame: Change from baseline to 18 months post birth of child
Bayley Scales
Child welfare involvement
Time frame: Change 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 reunifications
Time frame: Change 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Bard, PhD principal investigator
OUHSC
1 site in 1 country: see every site and its status.
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.