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Screening to Augment Referral to Treatment- Project START (ProjectSTART)

Primary Purpose

Alcohol Abuse, Tobacco Use Disorder, Marijuana Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interview
Treatment as Usual
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Abuse

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

In order to participate, women must meet the following criteria:

  1. Are non-pregnant and meet ASSIST criteria for at least moderate risk for alcohol (≥11) or drug (≥4) abuse or dependence (tobacco or illicit drugs, including cocaine, opiates, methamphetamine, marijuana or a prescription drug used in a medically inappropriate manner).
  2. Are pregnant and meet ASSIST criteria for at least mild to moderate risk for alcohol (≥6) or drug (≥4) abuse or dependence (alcohol, tobacco, an illicit drug, or a prescription drug in a medically inappropriate manner). We define pregnant women who use alcohol or drugs at least monthly in the last 90 days as eligible because alcohol and many of the other substances (eg. tobacco) are teratogens and use in pregnancy would be consistent with a diagnosis of abuse ("recurrent use in situations in which it is physically hazardous"). This level of use in pregnancy also indicates a greater likelihood of problematic substance use.
  3. Have used their primary substance at least once within the prior 28 days.
  4. Are aged 18 or more. We include participants who are aged 18 or older because parents may not be available at screening to provide consent for non-pregnant participants and subjects may not wish to disclose drug or alcohol abuse to a parent.

Exclusion Criteria:

Women are ineligible if they have any of the following criteria:

  1. Are unable to speak English.
  2. Are incarcerated or at risk of incarceration. The YNHH Women's Center provides care to incarcerated women. These individuals as well as those at risk of incarceration are excluded because incarceration precludes their ability to seek specialty drug or alcohol abuse treatment (a dependent measure).
  3. Have a cognitive disorder that would impair their ability to provide informed consent or provide accurate information.
  4. Require immediate hospitalization because of general medical needs or due to active suicidal or homicidal ideation or other behavioral health problems. We exclude individuals who are in need of immediate hospitalization because hospitalization will render it more difficult for them to immediately follow-up on a referral and because providers, rather than subjects, may be making the decision to initiate treatment. Hospitalization would also potentially force women who smoke to initiate treatment for tobacco addiction.
  5. Are currently participating or have participated in drug abuse treatment, including self-help interventions (eg. 12 step facilitation, smoking cessation interventions), within the last 3 months prior to screening.
  6. Are planning to relocate out of the area in the following 6 months. Women who relocate out of the area would be difficult to see for follow up assessments and it would be difficult to confirm treatment attendance in local treatment centers.
  7. Have previously participated in this protocol or
  8. Are unwilling to participate or accept randomization.

Sites / Locations

  • Yale-New Haven Hospital- York St Campus
  • Yale-New Haven Hospital-Chapel St Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Motivational Interview

Motivational Interview-Electronic

Treatment as Usual

Arm Description

Motivational interview provided by a clinical research nurse or physician.

Motivational Interview provided by an interactive computer program.

No intervention- resource list provided.

Outcomes

Primary Outcome Measures

Days Per Month of Primary Substance Use
Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.
Treatment Utilization
Treatment utilization assessed via participant self-report at each follow-up interview, and with the exception of self-help groups, verified with providers. We also reviewed the medical record for use of medication indicative of treatment (e.g., nicotine replacement therapy).

Secondary Outcome Measures

Rates of STDs
rates of incident std's per patient's medical records
Mean Cost for Each Intervention
The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs

Full Information

First Posted
August 3, 2011
Last Updated
March 2, 2017
Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01539525
Brief Title
Screening to Augment Referral to Treatment- Project START
Acronym
ProjectSTART
Official Title
Screening to Augment Referral to Treatment- Project START
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 5, 2011 (Actual)
Primary Completion Date
January 28, 2015 (Actual)
Study Completion Date
January 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators propose to use obstetric-gynecological clinics to conduct a randomized clinical trial that would compare two SBIRTS (Screening, Brief Intervention, Referral and Treatment), delivered either by a trained nurse or by computer, to usual care (a control condition). As part of this trial, the investigators will include outcomes that allow us to assess the cost effectiveness of these three conditions.
Detailed Description
Aim 1: To assess whether SBIRT, based upon motivational interviewing and delivered either by computer or a trained nurse, leads to decreased use of a subject's primary drug of abuse. Hypothesis #1a: Referrals based upon motivational principles and delivered by computer, as compared to usual care (health brochure with treatment resources), will lead to greater reductions in a woman's primary substance of abuse. Hypothesis #1b: Referrals based upon motivational principles and delivered by nurse, as compared to usual care (health brochure with treatment resources), will lead to greater reductions in a woman's primary substance of abuse. Aim 2: To determine whether SBIRT based upon motivational interviewing and delivered either by computer or by a nurse will promote substance abuse treatment utilization for the primary drug of abuse. Hypothesis #2a: Treatment utilization (eg. treatment initiation, attendance, use of quit-line or medication) will be higher if a woman receives the computer delivered brief intervention than if she receives usual care only. Hypothesis #2b: Treatment utilization (eg. treatment initiation, attendance, use of quit-line or medication) will be higher if a woman receives the nurse delivered brief intervention than if she receives usual care only. Secondary Aim 3: To evaluate whether SBI leads to a decrease in HIV/AIDS risk Hypothesis #3: Rates of sexually transmitted diseases, injection drug use and risky sexual behavior will be lower at follow up for subjects who receive either computer or a nurse delivered brief intervention than usual care subjects. Secondary Aim 4: To compare the relative cost-effectiveness of the three interventions. Hypothesis #4a: Screening and usual care will be the most cost-effective intervention method when the value of an additional unit of effect for the given individual's outcome is relatively low. Hypotheses #4b: Screening, and a brief intervention delivered by computer, will be the most cost-effective treatment method when the value of an additional unit of effect is relatively high. Hypotheses #4c: Screening, and a brief intervention delivered by a nurse, will be less cost-effective than a brief intervention delivered by computer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse, Tobacco Use Disorder, Marijuana Abuse, Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Participants received a behavioral intervention that could not be masked. Outcome data were self report and urine tests rom the participants.
Allocation
Randomized
Enrollment
439 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motivational Interview
Arm Type
Experimental
Arm Description
Motivational interview provided by a clinical research nurse or physician.
Arm Title
Motivational Interview-Electronic
Arm Type
Active Comparator
Arm Description
Motivational Interview provided by an interactive computer program.
Arm Title
Treatment as Usual
Arm Type
Placebo Comparator
Arm Description
No intervention- resource list provided.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interview
Intervention Description
Motivational Interview provided by either a Nurse or Computer
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Subjects given a brochure listing relevant recovery resources in the local area.
Primary Outcome Measure Information:
Title
Days Per Month of Primary Substance Use
Description
Participants completed a timeline followback at each assessment, reporting days of primary substance use. Outcomes reported are raw means and standard deviations.
Time Frame
7 non-overlapping monthly intervals from baseline to month 6
Title
Treatment Utilization
Description
Treatment utilization assessed via participant self-report at each follow-up interview, and with the exception of self-help groups, verified with providers. We also reviewed the medical record for use of medication indicative of treatment (e.g., nicotine replacement therapy).
Time Frame
baseline to 6 months
Secondary Outcome Measure Information:
Title
Rates of STDs
Description
rates of incident std's per patient's medical records
Time Frame
baseline to 6 months
Title
Mean Cost for Each Intervention
Description
The data table includes the mean cost for implementation of each intervention from the societal perspective. The costs do not include the research costs
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: In order to participate, women must meet the following criteria: Are non-pregnant and meet ASSIST criteria for at least moderate risk for alcohol (≥11) or drug (≥4) abuse or dependence (tobacco or illicit drugs, including cocaine, opiates, methamphetamine, marijuana or a prescription drug used in a medically inappropriate manner). Are pregnant and meet ASSIST criteria for at least mild to moderate risk for alcohol (≥6) or drug (≥4) abuse or dependence (alcohol, tobacco, an illicit drug, or a prescription drug in a medically inappropriate manner). We define pregnant women who use alcohol or drugs at least monthly in the last 90 days as eligible because alcohol and many of the other substances (eg. tobacco) are teratogens and use in pregnancy would be consistent with a diagnosis of abuse ("recurrent use in situations in which it is physically hazardous"). This level of use in pregnancy also indicates a greater likelihood of problematic substance use. Have used their primary substance at least once within the prior 28 days. Are aged 18 or more. We include participants who are aged 18 or older because parents may not be available at screening to provide consent for non-pregnant participants and subjects may not wish to disclose drug or alcohol abuse to a parent. Exclusion Criteria: Women are ineligible if they have any of the following criteria: Are unable to speak English. Are incarcerated or at risk of incarceration. The YNHH Women's Center provides care to incarcerated women. These individuals as well as those at risk of incarceration are excluded because incarceration precludes their ability to seek specialty drug or alcohol abuse treatment (a dependent measure). Have a cognitive disorder that would impair their ability to provide informed consent or provide accurate information. Require immediate hospitalization because of general medical needs or due to active suicidal or homicidal ideation or other behavioral health problems. We exclude individuals who are in need of immediate hospitalization because hospitalization will render it more difficult for them to immediately follow-up on a referral and because providers, rather than subjects, may be making the decision to initiate treatment. Hospitalization would also potentially force women who smoke to initiate treatment for tobacco addiction. Are currently participating or have participated in drug abuse treatment, including self-help interventions (eg. 12 step facilitation, smoking cessation interventions), within the last 3 months prior to screening. Are planning to relocate out of the area in the following 6 months. Women who relocate out of the area would be difficult to see for follow up assessments and it would be difficult to confirm treatment attendance in local treatment centers. Have previously participated in this protocol or Are unwilling to participate or accept randomization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Yonkers, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Steve Martino, PhD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital- York St Campus
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale-New Haven Hospital-Chapel St Campus
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will require data request with delineation of variables of interest. Only de-identified data will be released after evaluation of the request
Citations:
PubMed Identifier
31100713
Citation
Forray A, Martino S, Gilstad-Hayden K, Kershaw T, Ondersma S, Olmstead T, Yonkers KA. Assessment of an electronic and clinician-delivered brief intervention on cigarette, alcohol and illicit drug use among women in a reproductive healthcare clinic. Addict Behav. 2019 Sep;96:156-163. doi: 10.1016/j.addbeh.2019.05.007. Epub 2019 May 8.
Results Reference
derived
PubMed Identifier
30797381
Citation
Loree AM, Yonkers KA, Ondersma SJ, Gilstad-Hayden K, Martino S. Comparing satisfaction, alliance and intervention components in electronically delivered and in-person brief interventions for substance use among childbearing-aged women. J Subst Abuse Treat. 2019 Apr;99:1-7. doi: 10.1016/j.jsat.2019.01.007. Epub 2019 Jan 9.
Results Reference
derived

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Screening to Augment Referral to Treatment- Project START

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