Substance Use DisorderNCT06477848
Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care
A study testing Integrated Behavioral Health System with SUD Resources in people with Substance Use Disorder and Opioid Use Disorder, run by Indiana University at 1 site in United States.
Trial summary
This project seeks to address the increasing risk of overdose death, substance use disorder (SUD), and opioid use disorder (OUD) in adolescents. The investigators believe that pediatric primary care providers (PCP) could play an important role in helping youth with SUD because most adolescents see their PCPs for… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Substance Use Disorder, Opioid Use Disorder, Adolescent
- What is being tested?
- Integrated Behavioral Health System with SUD Resources
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient at one of the participating pediatric primary care team
- 12-18 years old
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
About this study
This project seeks to address the increasing risk of overdose death, substance use disorder (SUD), and opioid use disorder (OUD) in adolescents. The investigators believe that pediatric primary care providers (PCP) could play an important role in helping youth with SUD because most adolescents see their PCPs for annual wellness visits. However, PCPs have many barriers to treating their young patients with SUD/OUD: lack of training, resources, and support to deliver SUD/OUD services, limited time with patients, and the only available referral options often come with long wait times for an appointment.
Through this project, the investigators will build upon an existing Integrated Behavioral Health (IBH) system by offering stigma-reduction interventions and brief SUD interventions within primary care settings. The goal of this project is to learn if clinics participating in an Integrated Behavioral Healthcare Program with SUD resources will increase delivery of effective adolescent SUD care and ultimately lead to better health outcomes when compared to standard primary care treatment.
Read more
During the first project phase, the research team will gather a Parent and Youth Advisory Board, Primary Care Provider Advisory Board, and Integrated Care Expert Panel (Aim 1) to inform the development and refinement of the primary care-based SUD interventions. The investigators will gather input from national experts, local stakeholders, and PCPs to refine our screening to treatment approach (Aim 2), coupled with stigma reduction activities, within pediatric primary care.
During the second project phase, researchers will assess the impact of SUD IBH on PCP behaviors around adolescent SUD intervention. The investigators will interview and survey PCPs, clinic managers, and other clinical staff for willingness to engage in adolescent SUD treatment. The investigators will evaluate implementation outcomes (views toward SUD, stigma attitudes, IBH team dynamics; Aim 3) and effectiveness/reach outcomes (delivery of integrated primary care-based SUD services, the use of brief interventions for adolescents, number of consultation calls, and increased treatment engagement; Aim 4a), along with an exploratory test of local overdose rates for youth (Aim 4b), in order to examine local effects of the new intervention.
This project is supported by the HEAL Initiative (https://heal.nih.gov/).
Read the detailed description
Adolescents are at increasing risk of overdose death. Since 2020, the overdose crisis has expanded most rapidly among younger populations, largely because of the recent reality that any illicit substance (e.g., counterfeit pharmaceuticals, methamphetamines) used by adolescents has the potential to contain lethal amounts of fentanyl. Preventing overdose deaths, therefore, necessitates identifying and treating youth - not only with opioid use disorder (OUD) - but any substance use disorder (SUD).
The investigators seek to ensure a robust workforce is available and equipped to deliver interventions to youth with SUD. The investigators will do so by implementing a multifaceted intervention to change the cultural and procedural norms of pediatric primary care settings regarding adolescent SUD treatment. The investigators will take advantage of a large-scale roll out of integrated behavioral health (IBH) to improve assessment and treatment of adolescents with substance use and SUDs. Intervention components for this adolescent SUD IBH program consist of task-shifting within primary care settings to facilitate delivery of brief SUD intervention, case management, provider-to-provider (P2P) consultation regarding adolescent OUD pharmacology, telehealth SUD/OUD service delivery (when indicated) and stigma-reduction interventions.
The investigators argue that pediatric primary care providers (PCPs) could play a critical role in clinical management of adolescent SUD/OUD, since most youth attend annual well-child visits and PCPs already regularly engage around management of mental health disorders. However, current primary care norms present barriers to expanding the availability of effective SUD care for youth. First, most adolescent PCPs fail to sufficiently screen or inquire about SUD treatment needs, especially emergent needs associated with disorders like OUD. Relatedly, PCPs have notoriously limited time with patients, rendering appropriate SUD assessment and delivery of even brief interventions challenging to implement and sustain within primary care. While effective treatments and specialists are theoretically available for youth with SUD/OUD, stark workforce gaps in community-based behavioral healthcare prevent PCPs from being able to make meaningful referrals to services. For instance, of the Indiana buprenorphine prescribers surveyed by our team, less than 9% were willing to accept patients under age 18. Without viable referral options, PCPs face a conundrum about how best to care for their patients as they often lack formal SUD-related training, leaving them feeling unqualified to diagnose, discuss, and treat SUD/OUD in youth independently. Lastly, PCPs and their staff commonly hold high levels of stigmatizing attitudes toward people who use illicit substances and people treated for SUD, particularly OUD; PCP stigma is associated with less willingness to provide needed care. Empirically supported team-based solutions are needed to shift primary care norms, address stigma, and expand the workforce to meet the needs of adolescents with SUD/OUD.
The research team will capitalize on the infrastructure of three statewide initiatives to improve behavioral healthcare for adolescents: 1) IU Health's Pediatric Integrated Behavioral Health (IBH) Project, which is in the process of embedding behavioral healthcare providers/procedures in primary care practices across Indiana; 2) the Indiana Adolescent Addiction Access Program (AAA), a statewide provider to provider (P2P) consultation program focused on adolescent SUD/OUD; and 3) ENCOMPASS, an established hybrid telehealth outpatient dual diagnosis treatment program for adolescents with more severe SUD, including OUD. The primary purpose of the proposed intervention is to formally combine, build on, and increase uptake of the resources available through these initiatives to shift primary care practice toward delivering effective adolescent SUD care.
R61 Specific Aims: Convene a Parent and Youth Advisory Board, Primary Care Provider Advisory Board, and Integrated Care Expert Panel (Aim 1) to inform the development and refinement of the proposed primary care-based SUD interventions. The investigators will apply a person-centered research design approach with the expert panel to refine our screening to treatment approach (Aim 2), coupled with stigma reduction activities, within pediatric primary care.
R33 Specific Aims: Assess the impact of SUD IBH on PCP behaviors around adolescent SUD/OUD intervention. The investigators will conduct a cluster-randomized stepped-wedge trial to compare the effects of SUD IBH on PCP willingness to engage in adolescent SUD treatment. The investigators will evaluate implementation outcomes (views toward MOUD, stigma attitudes, IBH team dynamics; Aim 3) and effectiveness/reach outcomes (delivery of integrated primary care-based OUD/SUD services, the use of MOUD for adolescents, number of P2P consultation calls to AAA, and increased treatment engagement; Aim 4a), along with an exploratory test of local overdose rates for youth (Aim 4b), in order to examine local effects of the new intervention.
Here, the research team of clinician-scientists with expertise in etiology and treatment of adolescent SUDs, implementation science, and stigma reduction will study novel efforts to improve workforce capacity and willingness to deliver SUD services for youth. The research team is ideally situated in Indiana, where investigators can leverage the upcoming roll out of funded statewide behavioral health initiatives to rigorously evaluate how to best provide timely, evidence-based treatment for youth with SUD/OUD.
This project is supported by the HEAL Initiative (https://heal.nih.gov/).
- Conditions
- Substance Use Disorder, Opioid Use Disorder, Adolescent
- Being tested
- Integrated Behavioral Health System with SUD Resources
- Keywords
- Opioid Use, Opioid Use Disorder, Substance Use Disorder, Opioid, Treatment, Adolescent
- Medical subject headings
- Substance-Related Disorders, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Behavioral Health System with SUD ResourcesOther
This is a system-level intervention designed to improve collaboration among personnel from primary care clinics and SUD resources.
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Practice As Usual | No intervention | Data are collected regarding standard primary care practice and outcomes before implementation of SUD resources within the Integrated Behavioral Health System. |
| Integrated Behavioral Health with SUD Resources | Experimental | Participating clinics receive a system-level intervention, an Integrated Behavioral Health System with SUD Resources, designed to improve youth connection to substance use treatment. Receives: Other: Integrated Behavioral Health System with SUD Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence-Based Practice Attitudes Scale
15 items that gather general attitudes surrounding Evidence-Based Practices will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Measured: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
Primary Care Team Dynamics Survey
11 items that assess dynamics within Primary Care Clinic teams will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Measured: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
Implementation Leadership and Climate Scale
6 and 18 items to measure organization climate's support of adopting new innovations will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Measured: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
Attribution Questionnaire - SUD
18 items to measure adolescent SUD stigma will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Measured: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
Attitudes of Medication Opioid Use Disorder (MOUD) Treatment
15 items to measure attitudes toward MOUD treatment for adolescents with OUD will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Measured: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
Acceptability of Intervention, Intervention Appropriateness Measure, Feasibility of Intervention Measure
12 items to assess perceptions of acceptability, feasibility, and appropriateness of IBH will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Measured: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
Confidence, Barriers, and Feedback
6 items to measure confidence in ability to implement the model, barriers encountered, suggested improvements will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Measured: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
Provider Report of Sustainment Scale
3 items to measure sustainability or continued sue of IBH program will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Measured: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
Systems Usability Scale
12 items to measure electronic Health Record usability will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Measured: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
Stages of Implementation Completion (SIC)
The SIC is a measure of implementation process fidelity and allows for continuous measurement of implementation success. The SIC is an observation-based assessment tool that qualitatively measures intervention implementation process and fidelity. Assessment of the SIC results will be ongoing across the intervention time period and into sustainment.
Measured: From baseline through study completion, an average of 5 years
Screening Rates
Percent of youth screened for Substance Use
Measured: From clinical trial launch, data will be collected twice a year, for a total of four years.
Referral Rates
Percent of youth referred to SUD treatment
Measured: From clinical trial launch, data will be collected twice a year, for a total of four years.
Brief Substance Use Disorder (SUD) Treatment Engagement
Percent of indicated youth who received brief SUD treatment (e.g. Teen Intervene)
Measured: From clinical trial launch, data will be collected twice a year, for a total of four years.
Comprehensive SUD Treatment Engagement
Percent of indicated youth who received comprehensive SUD treatment (e.g. ENCOMPASS)
Measured: From clinical trial launch, data will be collected twice a year, for a total of four years.
MOUD Prescription
Prescription fills of MOUD to adolescents
Measured: From clinical trial launch, data will be collected twice a year, for a total of four years.
Provider 2 Provider (P2P) Consultation Calls
Number of P2P Consultation Calls
Measured: From clinical trial launch, data will be collected twice a year, for a total of four years.
Secondary outcomes (2)
Nonfatal overdose
EMS and ED records indicating OD
Measured: From clinical trial launch, data will be collected twice a year, for a total of four years.
Fatal overdose
Accidental OD death, vital records
Measured: From clinical trial launch, data will be collected twice a year, for a total of four years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start21 Feb 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will conduct a cluster-randomized stepped-wedge trial to compare the effects of SUD IBH on PCP willingness to engage in adolescent SUD treatment.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Leslie A Hulvershorn, Indiana University
- Investigators
- Leslie A Hulvershorn, MD, Principal investigator, Indiana University/Indiana University HealthZachary W Adams, PhD, Principal investigator, Indiana University/Indiana University HealthMatthew C Aalsma, PhD, Principal investigator, Indiana University/Indiana University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06477848
- Sponsor's protocol ID
- 23208
- Other IDs
- 1R61DA059948-01
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2024
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Workforce and System Change to Treat Adolescent Opioid Use Disorder Within Integrated Pediatric Primary Care
- ClinicalTrials.gov ID
- NCT06477848
- Acronym / sponsor ID
- 23208
- Conditions
- Substance Use Disorder, Opioid Use Disorder, Adolescent
- Keywords
- Opioid Use, Opioid Use Disorder, Substance Use Disorder, Opioid, Treatment, Adolescent
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 27 Jun 2024 (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 project seeks to address the increasing risk of overdose death, substance use disorder (SUD), and opioid use disorder (OUD) in adolescents. The investigators believe that pediatric primary care providers (PCP) could play an important role in helping youth with SUD because most adolescents see their PCPs for annual wellness visits. However, PCPs have many barriers to treating their young patients with SUD/OUD: lack of training, resources, and support to deliver SUD/OUD services, limited time with patients, and the only available referral options often come with long wait times for an appointment.
Through this project, the investigators will build upon an existing Integrated Behavioral Health (IBH) system by offering stigma-reduction interventions and brief SUD interventions within primary care settings. The goal of this project is to learn if clinics participating in an Integrated Behavioral Healthcare Program with SUD resources will increase delivery of effective adolescent SUD care and ultimately lead to better health outcomes when compared to standard primary care treatment.
During the first project phase, the research team will gather a Parent and Youth Advisory Board, Primary Care Provider Advisory Board, and Integrated Care Expert Panel (Aim 1) to inform the development and refinement of the primary care-based SUD interventions. The investigators will gather input from national experts, local stakeholders, and PCPs to refine our screening to treatment approach (Aim 2), coupled with stigma reduction activities, within pediatric primary care.
During the second project phase, researchers will assess the impact of SUD IBH on PCP behaviors around adolescent SUD intervention. The investigators will interview and survey PCPs, clinic managers, and other clinical staff for willingness to engage in adolescent SUD treatment. The investigators will evaluate implementation outcomes (views toward SUD, stigma attitudes, IBH team dynamics; Aim 3) and effectiveness/reach outcomes (delivery of integrated primary care-based SUD services, the use of brief interventions for adolescents, number of consultation calls, and increased treatment engagement; Aim 4a), along with an exploratory test of local overdose rates for youth (Aim 4b), in order to examine local effects of the new intervention.
This project is supported by the HEAL Initiative (https://heal.nih.gov/).
Detailed description
Adolescents are at increasing risk of overdose death. Since 2020, the overdose crisis has expanded most rapidly among younger populations, largely because of the recent reality that any illicit substance (e.g., counterfeit pharmaceuticals, methamphetamines) used by adolescents has the potential to contain lethal amounts of fentanyl. Preventing overdose deaths, therefore, necessitates identifying and treating youth - not only with opioid use disorder (OUD) - but any substance use disorder (SUD).
The investigators seek to ensure a robust workforce is available and equipped to deliver interventions to youth with SUD. The investigators will do so by implementing a multifaceted intervention to change the cultural and procedural norms of pediatric primary care settings regarding adolescent SUD treatment. The investigators will take advantage of a large-scale roll out of integrated behavioral health (IBH) to improve assessment and treatment of adolescents with substance use and SUDs. Intervention components for this adolescent SUD IBH program consist of task-shifting within primary care settings to facilitate delivery of brief SUD intervention, case management, provider-to-provider (P2P) consultation regarding adolescent OUD pharmacology, telehealth SUD/OUD service delivery (when indicated) and stigma-reduction interventions.
The investigators argue that pediatric primary care providers (PCPs) could play a critical role in clinical management of adolescent SUD/OUD, since most youth attend annual well-child visits and PCPs already regularly engage around management of mental health disorders. However, current primary care norms present barriers to expanding the availability of effective SUD care for youth. First, most adolescent PCPs fail to sufficiently screen or inquire about SUD treatment needs, especially emergent needs associated with disorders like OUD. Relatedly, PCPs have notoriously limited time with patients, rendering appropriate SUD assessment and delivery of even brief interventions challenging to implement and sustain within primary care. While effective treatments and specialists are theoretically available for youth with SUD/OUD, stark workforce gaps in community-based behavioral healthcare prevent PCPs from being able to make meaningful referrals to services. For instance, of the Indiana buprenorphine prescribers surveyed by our team, less than 9% were willing to accept patients under age 18. Without viable referral options, PCPs face a conundrum about how best to care for their patients as they often lack formal SUD-related training, leaving them feeling unqualified to diagnose, discuss, and treat SUD/OUD in youth independently. Lastly, PCPs and their staff commonly hold high levels of stigmatizing attitudes toward people who use illicit substances and people treated for SUD, particularly OUD; PCP stigma is associated with less willingness to provide needed care. Empirically supported team-based solutions are needed to shift primary care norms, address stigma, and expand the workforce to meet the needs of adolescents with SUD/OUD.
The research team will capitalize on the infrastructure of three statewide initiatives to improve behavioral healthcare for adolescents: 1) IU Health's Pediatric Integrated Behavioral Health (IBH) Project, which is in the process of embedding behavioral healthcare providers/procedures in primary care practices across Indiana; 2) the Indiana Adolescent Addiction Access Program (AAA), a statewide provider to provider (P2P) consultation program focused on adolescent SUD/OUD; and 3) ENCOMPASS, an established hybrid telehealth outpatient dual diagnosis treatment program for adolescents with more severe SUD, including OUD. The primary purpose of the proposed intervention is to formally combine, build on, and increase uptake of the resources available through these initiatives to shift primary care practice toward delivering effective adolescent SUD care.
R61 Specific Aims: Convene a Parent and Youth Advisory Board, Primary Care Provider Advisory Board, and Integrated Care Expert Panel (Aim 1) to inform the development and refinement of the proposed primary care-based SUD interventions. The investigators will apply a person-centered research design approach with the expert panel to refine our screening to treatment approach (Aim 2), coupled with stigma reduction activities, within pediatric primary care.
R33 Specific Aims: Assess the impact of SUD IBH on PCP behaviors around adolescent SUD/OUD intervention. The investigators will conduct a cluster-randomized stepped-wedge trial to compare the effects of SUD IBH on PCP willingness to engage in adolescent SUD treatment. The investigators will evaluate implementation outcomes (views toward MOUD, stigma attitudes, IBH team dynamics; Aim 3) and effectiveness/reach outcomes (delivery of integrated primary care-based OUD/SUD services, the use of MOUD for adolescents, number of P2P consultation calls to AAA, and increased treatment engagement; Aim 4a), along with an exploratory test of local overdose rates for youth (Aim 4b), in order to examine local effects of the new intervention.
Here, the research team of clinician-scientists with expertise in etiology and treatment of adolescent SUDs, implementation science, and stigma reduction will study novel efforts to improve workforce capacity and willingness to deliver SUD services for youth. The research team is ideally situated in Indiana, where investigators can leverage the upcoming roll out of funded statewide behavioral health initiatives to rigorously evaluate how to best provide timely, evidence-based treatment for youth with SUD/OUD.
This project is supported by the HEAL Initiative (https://heal.nih.gov/).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will conduct a cluster-randomized stepped-wedge trial to compare the effects of SUD IBH on PCP willingness to engage in adolescent SUD treatment.
| Arm | Type | Receives |
|---|---|---|
| Primary Care Practice As Usual | No intervention | –Data are collected regarding standard primary care practice and outcomes before implementation of SUD resources within the Integrated Behavioral Health System. |
| Integrated Behavioral Health with SUD Resources | Experimental | Other: Integrated Behavioral Health System with SUD ResourcesParticipating clinics receive a system-level intervention, an Integrated Behavioral Health System with SUD Resources, designed to improve youth connection to substance use treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patient at one of the participating pediatric primary care team
- 12-18 years old
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Integrated Behavioral Health System with SUD ResourcesThis is a system-level intervention designed to improve collaboration among personnel from primary care clinics and SUD resources. | Other | Integrated Behavioral Health with SUD Resources |
Primary outcome
Evidence-Based Practice Attitudes Scale
Time frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
15 items that gather general attitudes surrounding Evidence-Based Practices will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Primary Care Team Dynamics Survey
Time frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
11 items that assess dynamics within Primary Care Clinic teams will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Implementation Leadership and Climate Scale
Time frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
6 and 18 items to measure organization climate's support of adopting new innovations will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Attribution Questionnaire - SUD
Time frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
18 items to measure adolescent SUD stigma will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Attitudes of Medication Opioid Use Disorder (MOUD) Treatment
Time frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
15 items to measure attitudes toward MOUD treatment for adolescents with OUD will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Acceptability of Intervention, Intervention Appropriateness Measure, Feasibility of Intervention Measure
Time frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
12 items to assess perceptions of acceptability, feasibility, and appropriateness of IBH will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Confidence, Barriers, and Feedback
Time frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
6 items to measure confidence in ability to implement the model, barriers encountered, suggested improvements will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Provider Report of Sustainment Scale
Time frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
3 items to measure sustainability or continued sue of IBH program will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Systems Usability Scale
Time frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.
12 items to measure electronic Health Record usability will be administered to approximately 8 Primary Care Clinic team members and 2 system leaders from each site.
Stages of Implementation Completion (SIC)
Time frame: From baseline through study completion, an average of 5 years
The SIC is a measure of implementation process fidelity and allows for continuous measurement of implementation success. The SIC is an observation-based assessment tool that qualitatively measures intervention implementation process and fidelity. Assessment of the SIC results will be ongoing across the intervention time period and into sustainment.
Screening Rates
Time frame: From clinical trial launch, data will be collected twice a year, for a total of four years.
Percent of youth screened for Substance Use
Referral Rates
Time frame: From clinical trial launch, data will be collected twice a year, for a total of four years.
Percent of youth referred to SUD treatment
Brief Substance Use Disorder (SUD) Treatment Engagement
Time frame: From clinical trial launch, data will be collected twice a year, for a total of four years.
Percent of indicated youth who received brief SUD treatment (e.g. Teen Intervene)
Comprehensive SUD Treatment Engagement
Time frame: From clinical trial launch, data will be collected twice a year, for a total of four years.
Percent of indicated youth who received comprehensive SUD treatment (e.g. ENCOMPASS)
MOUD Prescription
Time frame: From clinical trial launch, data will be collected twice a year, for a total of four years.
Prescription fills of MOUD to adolescents
Provider 2 Provider (P2P) Consultation Calls
Time frame: From clinical trial launch, data will be collected twice a year, for a total of four years.
Number of P2P Consultation Calls
2 secondary outcomes
Nonfatal overdose
Time frame: From clinical trial launch, data will be collected twice a year, for a total of four years.
Fatal overdose
Time frame: From clinical trial launch, data will be collected twice a year, for a total of four years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
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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.
Leslie A Hulvershorn, MD principal investigator
Indiana University/Indiana University Health
Zachary W Adams, PhD principal investigator
Indiana University/Indiana University Health
Matthew C Aalsma, PhD principal investigator
Indiana University/Indiana University Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Behavioral Health System with SUD Resources in people with Substance Use Disorder and Opioid Use Disorder, run by Indiana University 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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 3 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence-Based Practice Attitudes Scale (time frame: Surveys will be collected prior to implementation, then continue every six months for a total of 1 year.). The study lists 16 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 3 Aug 2026.