<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04459000</url>
  </required_header>
  <id_info>
    <org_study_id>STARSProj</org_study_id>
    <nct_id>NCT04459000</nct_id>
  </id_info>
  <brief_title>Substance Use Treatment and Access to Resources (STARS) Project</brief_title>
  <official_title>Substance Use Treatment and Access to Resources (STARS) Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oklahoma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oklahoma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is evaluating a randomized clinical trial and a quasi-experimental observational&#xD;
      study combined. Pregnant women with substance abuse issues are referred to the Substance Use&#xD;
      Treatment and Recovery (STAR) prenatal clinic, and those who consent to participate in the&#xD;
      study will be randomized to the STAR + maternal Attachment Biobehavioral Catchup (mABC) home&#xD;
      visiting model or to the STAR only treatment group. Those who opt out of receiving prenatal&#xD;
      care at STAR will be recruited as a control group for the QED portion. Those randomized to&#xD;
      STAR + mABC will receive additional supports from a licensed therapist, including up to 12&#xD;
      home visits focused on substance exposed babies and positive parenting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is evaluating a randomized clinical trial and a quasi-experimental observational&#xD;
      study combined. Pregnant women with substance abuse issues are referred to the Substance Use&#xD;
      Treatment and Recovery (STAR) prenatal clinic, and those who consent to participate in the&#xD;
      study will be randomized to the STAR + maternal Attachment Biobehavioral Catchup (mABC) home&#xD;
      visiting model or to the STAR only treatment group. Those who opt out of receiving prenatal&#xD;
      care at STAR will be recruited as a control group for the QED portion. Those randomized to&#xD;
      STAR + mABC will receive additional supports from a licensed therapist, including up to 12&#xD;
      home visits focused on substance exposed babies and positive parenting. The study will focus&#xD;
      on the following specific aims:&#xD;
&#xD;
      A. Specific Aims&#xD;
&#xD;
      The Oklahoma Department of Mental Health and Substance Abuse Services (OKDMHSAS), in&#xD;
      partnership with two clinics at Children's Hospital at OU Medicine (CHOUM) - the Substance&#xD;
      use Treatment And Recovery (STAR) prenatal clinic and the A Better Chance Clinic (ABCC) for&#xD;
      infant assessment and treatment - have developed the Substance use Treatment and Access to&#xD;
      Resources and Supports (STARS) program for pregnant women who have a substance use issue. The&#xD;
      STARS program focuses on women residing in Oklahoma County (OK co.) who, at the time of&#xD;
      birth, are at risk of losing their infant to state custody care (child removal). The&#xD;
      effectiveness of combined focal services provided by the STAR (prenatal care, substance use&#xD;
      treatment supports and postpartum care) and the ABCC (assessment, evidence-based parent&#xD;
      training) clinics will be the target of the study described herein. The overarching goal of&#xD;
      the study is to evaluate the impact of these services on the well-being of and permanency&#xD;
      outcomes for children and families affected by substance abuse. The study will also evaluate&#xD;
      the quality of service implementation and the overall project's adherence to the following&#xD;
      objectives:&#xD;
&#xD;
      Objective 1: Develop training and cross-training to increase the knowledge base of the&#xD;
      medical, therapy, and child welfare. The key element of this objective is to increase the&#xD;
      state's capacity to deliver collaborative and integrated services to serve children ages 0-3&#xD;
      and their families. The STARS will increase the health care and child welfare workforce's&#xD;
      capacity by disseminating emerging and evidence-based services for substance-exposed newborns&#xD;
      and Fetal Alcohol Spectrum Disorder. The ODMHSAS and OKDHS plan to enhance cross-systems&#xD;
      interventions that bridge agencies at policy and practice levels by pursuing procedural and&#xD;
      policy modifications and formalize agreements to implement targeted evidence-based training&#xD;
      that will enhance the knowledge base of statewide substance use disorder treatment providers,&#xD;
      child welfare and health care professionals. Because of the state and local infrastructure,&#xD;
      the ODMHSAS has developed to date, key partnerships, and access to data, the program is&#xD;
      well-positioned to focus on substance-exposed newborns and their families as Oklahoma&#xD;
      continues to strengthen and expand the statewide service and workforce capacity.&#xD;
&#xD;
      Objective 2: Enhance the well-being of children, parents, and families; and improve safe and&#xD;
      permanent caregiving relationships. The key element of this objective is to improve&#xD;
      evidence-based practices to address attachment and bonding that will serve the mother and&#xD;
      baby. To achieve this, the STARS program will collaborate with A Better Chance Clinic (ABCC)&#xD;
      at OUHSC to implement modified maternal Attachment Biobehavioral Catchup (mABC) adaptation&#xD;
      for pre and postnatal babies. mABC is an intervention adapted from an evidence-based&#xD;
      intervention for children who have experienced adversity (e.g., neglect). This adapted&#xD;
      intervention specifically targets the challenges of infants born to opioid-dependent mothers.&#xD;
&#xD;
      Objective 3: Improve retention in substance use treatment and successful completion of&#xD;
      treatment for parents: STARS program will utilize an array of EBPs to improve treatment&#xD;
      retention and encourage completion of treatment services. Treatment outcomes are increased by&#xD;
      offering services to meet the parent's needs. Motivational Interviewing (MI), Community&#xD;
      Reinforcement Approach (CRA), and Seeking Safety (SS) and Cognitive Process Therapy for&#xD;
      trauma (CPT) will be utilized to address the treatment needs.&#xD;
&#xD;
      Objective 4: Facilitate the implementation, delivery, and effectiveness of prevention&#xD;
      services and programs under the Family First Prevention Services Act of 2018 for at-risk&#xD;
      families: Under Division E, Title VII - Family First Prevention Services Act, listed under&#xD;
      Prevention Activities under Title IV-E, it allows title IV-E dollars to fund promising,&#xD;
      supported, and well-supported mental health and substance abuse prevention and treatment&#xD;
      provided by a qualified clinician, and in-home parent skill-based programs, for up to 12&#xD;
      months for candidates for foster care and for pregnant or parenting foster youth. ODMHSAS&#xD;
      will develop memorandums of understandings, conducting multidisciplinary teams, and providing&#xD;
      the evidence-based services that treat families that are at risk in compliance with this&#xD;
      services act.&#xD;
&#xD;
      Objective 5: Decrease the number of out of home placements for children by enhancing the&#xD;
      safety of children prior to delivery: ODMHSAS with collaboration with OKDHS will develop&#xD;
      Plans of Safe Care prior to delivery. The STARS program will implement Wraparound services to&#xD;
      connect families to resources to support the mother and baby after delivery to ensure they&#xD;
      have a safe environment and lifestyle.&#xD;
&#xD;
      Objective 6: Decrease the number of out of home placements for children at risk: The STARS&#xD;
      program will provide various services and supports prior to delivery of the baby. The program&#xD;
      will offer prenatal care; Medication-Assisted Treatment (MAT) when applicable, substance use&#xD;
      treatment through telehealth or in-person, peer recovery, housing and employment, and&#xD;
      aftercare supports.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 16, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mother substance use</measure>
    <time_frame>Change from baseline to 18 months post birth of child</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mother contraceptive use</measure>
    <time_frame>Change from baseline to 18 months post birth of child</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mother depressive symptoms</measure>
    <time_frame>Change from baseline to 18 months post birth of child</time_frame>
    <description>Center for Epidemiological Studies Depression Screener score</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child development</measure>
    <time_frame>Change from baseline to 18 months post birth of child</time_frame>
    <description>Infant and Toddler Sensory Profile</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child development</measure>
    <time_frame>Change from baseline to 18 months post birth of child</time_frame>
    <description>Bayley Scales</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child welfare involvement</measure>
    <time_frame>Change from baseline to 18 months post birth of child</time_frame>
    <description>Are there group differences in the rate of child removals by protective services? Count of children removed using Child Welfare data.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Child welfare reunifications</measure>
    <time_frame>Change from baseline to 18 months post birth of child</time_frame>
    <description>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.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">242</enrollment>
  <condition>Substance Use Disorders</condition>
  <condition>Pregnancy Related</condition>
  <condition>Child Neglect</condition>
  <arm_group>
    <arm_group_label>STARs Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Consenting research participant who receive prenatal care services in the STAR clinic, but are not randomized to receive mABC home visiting services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>STARS + mABC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consenting research participant who receive prenatal care services in the STAR clinic, and are randomized to receive mABC home visiting services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group/CHOUM Only</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>These are research participants who were eligible to receive care in the STAR clinic, but did not opt to receive that care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>STARS + maternal Attachment Biobehavioral Catchup home visiting model</intervention_name>
    <description>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.</description>
    <arm_group_label>STARS + mABC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>STARs Only</intervention_name>
    <description>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).</description>
    <arm_group_label>STARs Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman with substance abuse issue occurring during pregnancy&#xD;
&#xD;
          -  Eligible for services at the STAR prenatal clinic&#xD;
&#xD;
          -  Speaks/comprehends English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to read English at 8th grade comprehension level&#xD;
&#xD;
          -  Those outside of Oklahoma City metropolitan area.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Bard, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>OUHSC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mallory Ford, MS</last_name>
    <phone>405-271-8858</phone>
    <email>mallory-ford@ouhsc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Geneva Marshall, MS</last_name>
    <phone>4052718858</phone>
    <phone_ext>53421</phone_ext>
    <email>geneva-marshall@ouhsc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73117</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mallory Ford</last_name>
      <phone>405-271-8858</phone>
      <email>mallory-ford@ouhsc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Geneva marshall</last_name>
      <phone>405-2718858</phone>
      <phone_ext>53421</phone_ext>
      <email>geneva-marshall@ouhsc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04459000
org study id: STARSProj
nct id: NCT04459000
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: 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.
measure: Mother substance use
time frame: Change from baseline to 18 months post birth of child
description: 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.
measure: Mother contraceptive use
time frame: Change from baseline to 18 months post birth of child
description: 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.
measure: Mother depressive symptoms
time frame: Change from baseline to 18 months post birth of child
description: Center for Epidemiological Studies Depression Screener score
measure: Child development
time frame: Change from baseline to 18 months post birth of child
description: Infant and Toddler Sensory Profile
measure: Child development
time frame: Change from baseline to 18 months post birth of child
description: Bayley Scales
measure: Child welfare involvement
time frame: Change from baseline to 18 months post birth of child
description: Are there group differences in the rate of child removals by protective services? Count of children removed using Child Welfare data.
measure: Child welfare reunifications
time frame: Change from baseline to 18 months post birth of child
description: 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.
arm group label: STARs Only
arm group type: Active Comparator
description: Consenting research participant who receive prenatal care services in the STAR clinic, but are not randomized to receive mABC home visiting services.
arm group label: STARS + mABC
arm group type: Experimental
description: Consenting research participant who receive prenatal care services in the STAR clinic, and are randomized to receive mABC home visiting services.
arm group label: Control Group/CHOUM Only
arm group type: No Intervention
description: These are research participants who were eligible to receive care in the STAR clinic, but did not opt to receive that care.
intervention type: Behavioral
intervention name: STARS + maternal Attachment Biobehavioral Catchup home visiting model
description: 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.
arm group label: STARS + mABC
intervention type: Behavioral
intervention name: STARs Only
description: 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).
arm group label: STARs Only
criteria: 
gender: All
minimum age: N/A
maximum age: 55 Years
healthy volunteers: No
last name: David Bard, PhD
role: Principal Investigator
affiliation: OUHSC
last name: Mallory Ford, MS
phone: 405-271-8858
email: mallory-ford@ouhsc.edu
last name: Geneva Marshall, MS
phone: 4052718858
phone ext: 53421
email: geneva-marshall@ouhsc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Substance-Related Disorders
sharing ipd: No