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Alcohol-Related DisordersNCT05910580

Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

A study testing Screening, Brief Intervention, and Referral to Treatment (SBIRT) in people with Alcohol-Related Disorders and Substance-Related Disorders, run by Emory University at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
4 sitesUnited States
Study dates
3 Jul 2025to 31 May 2027
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Over the age of 18 years
  • U.S. residing
  • Have internet access (own a computer or smart phone)
  • Screen positive to one or more risky alcohol and substance use behaviors as determined by our standardized abbreviated instruments

Who cannot join

  • Not capable of communicating (reading, speaking, writing) in English or Spanish

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kelli S Hall, PhD MS contact

212-305-4805

ksh2110@cumc.columbia.edu

Jessica LaHote, MPH contact

212-305-4805

jl5348@cumc.columbia.edu

United States4 sites, 4 recruiting

  • Greater Boston Health Center

    Boston, Massachusetts, 02215

    Recruiting

  • Metro West Health Center

    Marlborough, Massachusetts, 01752

    Recruiting

  • Western Massachusetts Health Center

    Springfield, Massachusetts, 01107

    Recruiting

  • Central Massachusetts Health Center

    Worcester, Massachusetts, 01609

    Recruiting

Other trials in United States

About this study

Official title: Improving Alcohol and Substance Use Care Access, Outcomes, and Equity During the Reproductive Years: A Type 1 Hybrid Trial in Family Planning Clinics

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic.

The main questions it aims to answer are:

Read more
  • Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing?
  • Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity?
  • Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)?

Participants will receive in-person and telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months.

Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

Read the detailed description

Risky alcohol and drug use are associated with severe, negative, and long-term health outcomes and disparities, including sexual and reproductive health (SRH), among reproductive aged people in the United States. High rates and sequelae of alcohol and drug use disproportionately experienced by structurally marginalized groups shape lifelong health inequities for people of racial/ethnic minority, living in poverty, and residing in under-resourced and under-served communities. Among populations at risk of pregnancy-related sequelae (predominantly those self-identifying as women and thus this study's primary focus), harmful alcohol and substance use and alcohol use disorders (AUDs)/substance use disorders (SUDs) contribute to condom and contraceptive nonuse among those not intending pregnancy, sex while intoxicated, non-consensual sex, violence/rape, sexually transmitted infections, unintended pregnancy, and maternal and infant morbidity and mortality.

Family planning (FP) clinics are uniquely well-suited but entirely untapped sites for implementing and scaling integrated alcohol/substance use services. Largely community-based health centers that are publicly funded and/or serve Medicaid enrollees, FP clinics are a trusted care source and primary access point for reproductive aged women, and a safety net for the most socially disadvantaged groups. Yet few, if any, studies have rigorously evaluated interventions or implementation strategies to accelerate the uptake of alcohol/substance services in FP contexts. In obstetrics and HIV, widespread adoption of evidence-based SBIRT (screening, brief intervention, and referral to treatment) is precluded by multi-level barriers; data on specific challenges faced by FP providers are lacking. Virtually nothing is known about telemedicine, which has been rolled out for contraception and other routine visits during the pandemic, as a technological infrastructure for SBIRT. Whether and how the promising strategy of Implementation and Sustainment Facilitation (ISF) can bridge systems barriers and support scale up in FP settings is unknown.

The researchers of this study propose an explanatory, sequential, mixed methods study of alcohol and drug SBIRT in an expansive FP clinic network - a novel and highly impactful setting with a national reach of a diverse and largely structurally disadvantaged population of reproductive-aged women at greatest risk for AUDs/SUDs. The researchers will conduct a randomized Type 1 Hybrid Effectiveness-Implementation Trial within a large Northeastern regional affiliate and its four clinics of a national SRH care organization.

Results will inform an evidence-based, innovative, stakeholder-driven FP SBIRT model in response to the high-level calls for integrated women's health care. With concrete guidance for scaling alcohol/ drug services in SRH settings nationally, findings will promote women's health equity across the U.S.

Being tested
Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Keywords
Implementation Science, Mass Screening, Motivational Interviewing, Referral and Consultation, Quality of Health Care, Early Medical Intervention, Family Planning Services, Primary Health Care, Reproductive Health Services, Telemedicine, Preconception Care, Young Adult
Medical subject headings
Alcohol-Related Disorders, Substance-Related Disorders, Psychological Well-Being, Sexually Transmitted Diseases

What participants receive

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

  • Screening, Brief Intervention, and Referral to Treatment (SBIRT)Behavioural

    Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based approach supported by national healthcare organizations, including the Preventative Services Task Force and the American College of Obstetrics and Gynecologists. Validated tools will efficiently screen an individual's substance use risk. Patients who screen in the risky/harmful range then receive a brief motivational interviewing-based intervention adapted from the evidence-based Brief Negotiated Interview, lasting 5-10 minutes, which provides feedback, helps explore health risks, and motivates change. Individuals who screen in the severe category, indicating a likely AUD/SUD, also receive a brief intervention, aimed at increasing motivation to accept a referral to treatment, and requiring a more intensive approach will also receive a warm-hand off referral to specialty addiction treatment. Procedures for SBIRT delivery will be adapted to the flow of telemedicine visits.

Study groups in NCT05910580
Study groupRoleWhat they receive
Screening, Brief Intervention, and Referral to Treatment (SBIRT)ExperimentalPatients at study clinics who are randomized to receive the Screening, Brief Intervention, and Referral to Treatment (SBIRT) intervention, which is delivered in-person and through telemedicine.
Receives: Behavioral: Screening, Brief Intervention, and Referral to Treatment (SBIRT)
Usual CareNo interventionPatients at study clinics who are randomized to receive usual care. None of the clinic sites have implemented standardized screening, brief intervention, or referral to treatment components. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.

What is being measured

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

  1. Average Number of Drinks Per Drinking Day

    Participants are asked to self-report the number of drinks consumed on days when alcohol was consumed, during the past 30 days.

    Measured: Baseline, Day 30, Month 3

  2. Number of Days of Drug Use

    Participants are asked to self-report the number of days of drug use in the past 30 days.

    Measured: Baseline, Day 30, Month 3

  3. Incidence of sex under influence of alcohol/drugs

    Any incidence of sex under influence of alcohol/drugs in past 30 days.

    Measured: Baseline, Day 30, Month 3

  4. Number of events of sex under influence of alcohol/drugs

    The number of events of sex while under influence of alcohol/drugs in past 30 days.

    Measured: Baseline, Day 30, Month 3

  5. Patient Health Questionnaire (PHQ-9)

    The Patient Health Questionnaire (PHQ-9) is a 9-item instrument assessing symptoms of depression during the prior two weeks. Responses are given on a 4-point scale where 0 = not at all and 3 = nearly everyday. Total scores range from 0 to 27 where higher scores indicate greater feelings of depression. Scores of 0 to 4 indicate minimal depression, scores of 5 to 9 indicate mild depression, scores of 10 to 14 indicate moderate depression, scores of 15 to 19 indicate moderately severe depression, and scores of 20 or more indicate severe depression.

    Measured: Baseline, Day 30, Month 3

  6. Number of Clinic Patients Receiving a Brief Intervention During Implementation Phase

    The number of patients in each clinic who screen positive receiving a brief intervention during the implementation phase of the study.

    Measured: During the 12-month implementation phase

  7. Number of Clinic Patients Receiving a Brief Intervention During Sustainment Phase

    The number of patients in each clinic who screen positive who receive a brief intervention during the sustainment phase of the study.

    Measured: During the 12-month sustainment phase

  8. Number of Providers Using SBIRT During Implementation Phase

    The number of providers in each clinic using SBIRT during the implementation phase.

    Measured: During the 12-month implementation phase

  9. Number of Clinics Using SBIRT During Sustainment Phase

    The number of clinics using SBIRT during the sustainment phase.

    Measured: During the 12-month sustainment phase

  10. Number of Providers Using SBIRT During Sustainment Phase

    The number of providers in each clinic using SBIRT during the sustainment phase.

    Measured: During the 12-month sustainment phase

  11. Number of Completed BIOS Tracking Sheets to Achieve Competency

    The number of completed Brief Intervention Observation Sheets (BIOS) needed to achieve competency will be examined.

    Measured: During the preparation phase

  12. Brief Intervention Observation Sheet (BIOS) Score

    Fidelity to the intervention is assessed as the mean score on the first 10 items of the Brief Intervention Observation Sheet (BIOS). The score per provider is determined from a sample of audio recorded brief interventions. Responses to items are recorded as a "yes" or "no" assessment of whether the steps of the brief intervention were completed. The total score is the number of "yes" items and can range from 0 to 10, with higher scores indicating more steps completed.

    Measured: During the 12-month implementation phase

  13. Brief Intervention Observation Sheet (BIOS) Score - Motivational Style

    Fidelity to the intervention is assessed as the mean score on the 11th item of the Brief Intervention Observation Sheet (BIOS). The score per provider is determined from a sample of audio recorded brief interventions. Item 11 assesses the overall motivational interviewing style used by the provider. Scores are rated on a 7-point scale where 1 = not at all and 7 = very effectively. Higher scores indicate greater motivational interviewing style.

    Measured: During the 12-month implementation phase

Secondary outcomes (22)

  1. Number of Days of Alcohol Use

    Participants are asked to self-report the number of days they consumed alcohol during the past 30 days.

    Measured: Baseline, Day 30, Month 3

  2. Number of Days of Binge Drinking

    Participants are asked to self-report the number of days they consumed 4 or more alcoholic drinks per day during the past 30 days.

    Measured: Baseline, Day 30, Month 3

  3. Alcohol Use Disorders Identification Test-Concise (AUDIT-C) Score

    The Alcohol Use Disorders Identification Test-Concise (AUDIT-C) is a 3-item alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The questionnaire asks about drinking behavior in the past 30 days. Responses to items are given on a 5-point scale where 0 = never and 4 = the highest frequency of alcohol use or consumption per drinking day. Total scores range from 0 (non-drinkers) to 12. Higher scores indicate that a person's alcohol consumption is likely to affect his or her health and safety.

    Measured: Baseline, Day 30, Month 3

  4. Drug Abuse Screening Test (DAST-10) Score

    The Drug Abuse Screening Test (DAST-10) is a 10-item instrument assessing drug use (not including alcohol and tobacco use). Each item is responded to as "yes" or "no" and the total score is the sum of all "yes" responses. Total scores range from 0 to 10 with a score of 0 indicating that no problems are reported and the degree of problems related to drug abuse increase as the total score increases. Scores of 1 or 2 indicate a low level of problems, scores of 3 to 5 indicate a moderate level of problems, scores of 6 to8 indicate substantial levels of problems, and scores of 9 and 10 indicate severe levels of problems related to drug abuse.

    Measured: Baseline, Day 30, Month 3

  5. Incidence of condom nonuse

    Participants are asked to report any incidence of condom nonuse monogamous encounters in the past 30 days, among women not intending pregnancy.

    Measured: Baseline, Day 30, Month 3

  6. Number of events of condom nonuse

    Participants reporting condom nonuse are asked to report the number of events of condom nonuse monogamous encounters in the past 30 days, among women not intending pregnancy.

    Measured: Baseline, Day 30, Month 3

  7. Incidence of contraceptive nonuse

    Participants are asked to report any incidence of contraceptive nonuse monogamous encounters in the past 30 days, among women not intending pregnancy.

    Measured: Baseline, Day 30, Month 3

  8. Number of events of contraceptive nonuse

    Participants reporting contraception nonuse are asked to report the number of events of contraceptive nonuse monogamous encounters in the past 30 days, among women not intending pregnancy.

    Measured: Baseline, Day 30, Month 3

  9. Incidence of regretted/nonconsensual sex and sexual violence

    Participants are asked to report any incidence of non-consensual sex, regretted sex, or sexual violence in past 30 days.

    Measured: Baseline, Day 30, Month 3

  10. Number of events of regretted/nonconsensual sex and sexual violence

    Participants reporting non-consensual sex, regretted sex, or sexual violence in past 30 days are asked to report the number of events.

    Measured: Baseline, Day 30, Month 3

  11. Unintended pregnancy

    Participants are asked to report any incidence of unintended pregnancy occurring in the past 30 days.

    Measured: Baseline, Day 30, Month 3

  12. Generalized Anxiety Disorder 7-item (GAD-7) Scale Score

    The Generalized Anxiety Disorder 7-item (GAD-7) instrument is a well-validated patient self-report scale measuring anxiety severity. Participants respond to statements to indicate how often they have been bothered by specified symptoms of anxiety (such as "feeling nervous, anxious, or on edge). Response choices include 0 = not at all sure, 1 = several days, 2 = over half the days, and 3 = nearly every day. Total scores range from 0 to 21 with higher scores indicating increased anxiety. A score of 0 to 4 indicates minimal anxiety, scores of 5 to 9 indicate mild anxiety, scores of 10 to 14 indicate moderate anxiety, and scores of 15 to 21 indicate severe anxiety.

    Measured: Baseline, Day 30, Month 3

  13. World Health Organization-Five Well-Being Index (WHO-5) Score

    The World Health Organization-Five Well-Being Index (WHO-5) a 5-item scale that measures subjective psychological well-being in past 14 days. Responses to items are given on a 6-point scale where 0 = at no time and 5 = all of the time. Total raw scores range from 0 to 25, with 0 representing the worst possible and 25 representing the best possible quality of life. Scores can also be multiplied by 4 to obtain a percentage score ranging from 0 to 100, where 0 represents the worst possible quality of life and 100 represents the best possible quality of life.

    Measured: Baseline, Day 30, Month 3

  14. General Self-reported Health Score

    Likert rating of general self-reported health in past 30 days

    Measured: Baseline, Day 30, Month 3

  15. 12-Item Short Form (SF-12) Health Survey Score

    Quality of life is assessed with the SF-12 Health Survey. The SF-12 is a multipurpose, standardized self-report short form survey with 12 questions assessing mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.

    Measured: Baseline, Day 30, Month 3

  16. Number of Patients Screened During Implementation Phase

    The number of patients, out of all patients seen at the study sites, who are screened during the implementation phase.

    Measured: During the 12-month implementation phase

  17. Number of Patients Screened During Sustainment Phase

    The number of patients, out of all patients seen at the study sites, who are screened during the sustainment phase.

    Measured: During the 12-month sustainment phase

  18. Number of Patients Receiving Referral During Implementation Phase

    The number of patients who screen at a severe level of alcohol use, who receive a referral during the implementation phase.

    Measured: During the 12-month implementation phase

  19. Number of Patients Receiving Referral During Sustainment Phase

    The number of patients who screen at a severe level of alcohol use, who receive a referral during the sustainment phase.

    Measured: During the 12-month sustainment phase

  20. University of Missouri-Kansas City Screening & Brief Intervention Knowledge Assessment Score

    SBIRT knowledge is assessed with the University of Missouri-Kansas City Screening \& Brief Intervention Knowledge Assessment. This instrument will be completed by providers undergoing training in SBIRT. Scores range from 0-20, with higher scores indicating more knowledge of SBIRT.

    Measured: During the implementation phase

  21. Brief Intervention Observation Sheet (BIOS) Score During Preparation Phase

    Fidelity to the intervention is assessed as the mean score on the first 10 items of the Brief Intervention Observation Sheet (BIOS), from the last observation conducted during provider training. The score per provider is determined from a sample of audio recorded brief interventions. Responses to items are recorded as a "yes" or "no" assessment of whether the steps of the brief intervention were completed. The total score is the number of "yes" items and can range from 0 to 10, with higher scores indicating more steps completed.

    Measured: During the preparation and implementation phases

  22. Brief Intervention Observation Sheet (BIOS) Score - Motivational Style

    Fidelity to the intervention is assessed as the mean score on the 11th item of the Brief Intervention Observation Sheet (BIOS), from the last observation conducted during provider training. The score per provider is determined from a sample of audio recorded brief interventions. Item 11 assesses the overall motivational interviewing style used by the provider. Scores are rated on a 7-point scale where 1 = not at all and 7 = very effectively. Higher scores indicate greater motivational interviewing style.

    Measured: During the preparation and implementation phases

Timeline

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

  1. First posted18 Jun 2023
  2. Study start3 Jul 2025
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05910580
Sponsor's protocol ID
STUDY00005766
Other IDs
R01AA030529
Status last verified
Jun 2026
First submitted
19 May 2023
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Per the NIAAA Exemption Request Committee's determination electronic health records/administrative records data components will not be shared. Quantitative survey data will be shared.

Publications

  • Tan CH, Denny CH, Cheal NE, Sniezek JE, Kanny D. Alcohol use and binge drinking among women of childbearing age - United States, 2011-2013. MMWR Morb Mortal Wkly Rep. 2015 Sep 25;64(37):1042-6. doi: 10.15585/mmwr.mm6437a3.

    PubMed 26401713

  • Naimi TS, Lipscomb LE, Brewer RD, Gilbert BC. Binge drinking in the preconception period and the risk of unintended pregnancy: implications for women and their children. Pediatrics. 2003 May;111(5 Pt 2):1136-41.

    PubMed 12728126

  • Thomas AG, Brodine SK, Shaffer R, Shafer MA, Boyer CB, Putnam S, Schachter J. Chlamydial infection and unplanned pregnancy in women with ready access to health care. Obstet Gynecol. 2001 Dec;98(6):1117-23.

    PubMed 11755563

  • Kesmodel U, Wisborg K, Olsen SF, Henriksen TB, Secher NJ. Moderate alcohol intake in pregnancy and the risk of spontaneous abortion. Alcohol Alcohol. 2002 Jan-Feb;37(1):87-92. doi: 10.1093/alcalc/37.1.87.

    PubMed 11825863

  • Iyasu S, Randall LL, Welty TK, Hsia J, Kinney HC, Mandell F, McClain M, Randall B, Habbe D, Wilson H, Willinger M. Risk factors for sudden infant death syndrome among northern plains Indians. JAMA. 2002 Dec 4;288(21):2717-23. doi: 10.1001/jama.288.21.2717.

    PubMed 12460095

  • Heil SH, Jones HE, Arria A, Kaltenbach K, Coyle M, Fischer G, Stine S, Selby P, Martin PR. Unintended pregnancy in opioid-abusing women. J Subst Abuse Treat. 2011 Mar;40(2):199-202. doi: 10.1016/j.jsat.2010.08.011. Epub 2010 Oct 30.

    PubMed 21036512

  • Ko JY, Wolicki S, Barfield WD, Patrick SW, Broussard CS, Yonkers KA, Naimon R, Iskander J. CDC Grand Rounds: Public Health Strategies to Prevent Neonatal Abstinence Syndrome. MMWR Morb Mortal Wkly Rep. 2017 Mar 10;66(9):242-245. doi: 10.15585/mmwr.mm6609a2.

    PubMed 28278146

  • National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Population Health and Public Health Practice; Committee on the Examination of the Integration of Opioid and Infectious Disease Prevention Efforts in Select Programs. Opportunities to Improve Opioid Use Disorder and Infectious Disease Services: Integrating Responses to a Dual Epidemic. Washington (DC): National Academies Press (US); 2020 Jan 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK555809/

    PubMed 32293827

  • Terplan M, Lawental M, Connah MB, Martin CE. Reproductive Health Needs Among Substance Use Disorder Treatment Clients. J Addict Med. 2016 Jan-Feb;10(1):20-5. doi: 10.1097/ADM.0000000000000175.

    PubMed 26690290

  • Cornford CS, Close HJ, Bray R, Beere D, Mason JM. Contraceptive use and pregnancy outcomes among opioid drug-using women: a retrospective cohort study. PLoS One. 2015 Mar 4;10(3):e0116231. doi: 10.1371/journal.pone.0116231. eCollection 2015.

    PubMed 25739018

  • Stanhope TJ, Gill LA, Rose C. Chronic opioid use during pregnancy: maternal and fetal implications. Clin Perinatol. 2013 Sep;40(3):337-50. doi: 10.1016/j.clp.2013.05.015. Epub 2013 Jul 4.

    PubMed 23972743

  • Kellogg A, Rose CH, Harms RH, Watson WJ. Current trends in narcotic use in pregnancy and neonatal outcomes. Am J Obstet Gynecol. 2011 Mar;204(3):259.e1-4. doi: 10.1016/j.ajog.2010.12.050.

    PubMed 21376165

  • Pinedo M. Help seeking behaviors of Latinos with substance use disorders who perceive a need for treatment: Substance abuse versus mental health treatment services. J Subst Abuse Treat. 2020 Feb;109:41-45. doi: 10.1016/j.jsat.2019.11.006. Epub 2019 Nov 14.

    PubMed 31856949

  • Hadland SE, Copelas SH, Harris SK. Trajectories of Substance Use Frequency among Adolescents Seen in Primary Care: Implications for Screening. J Pediatr. 2017 May;184:178-185. doi: 10.1016/j.jpeds.2017.01.033. Epub 2017 Feb 10.

    PubMed 28196680

  • Chavez LJ, Kelleher KJ, Matson SC, Wickizer TM, Chisolm DJ. Mental Health and Substance Use Care Among Young Adults Before and After Affordable Care Act (ACA) Implementation: A Rural and Urban Comparison. J Rural Health. 2018 Dec;34(1):42-47. doi: 10.1111/jrh.12258. Epub 2017 Jul 7.

    PubMed 28685885

Questions about this trial

What is this clinical trial studying?

A study testing Screening, Brief Intervention, and Referral to Treatment (SBIRT) in people with Alcohol-Related Disorders and Substance-Related Disorders, run by Emory University at 4 sites 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 4 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Contact Kelli S Hall, PhD MS (212-305-4805, ksh2110@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Number of Drinks Per Drinking Day (time frame: Baseline, Day 30, Month 3). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05910580, which also lists 31 linked publications.

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 15 Jun 2026.

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