Screening to Augment Referral to Treatment- Project START

NCT01539525 | Completed Results

• 2 other identifiers: 1005006785R01DA027194
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcohol Abuse; Tobacco Use Disorder; Marijuana Abuse; Substance-Related Disorders

Outcome Measures

Primary Outcomes (2)

• 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.

  7 non-overlapping monthly intervals from baseline to month 6

• 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).

  baseline to 6 months

Secondary Outcomes (2)

• Rates of STDs

  baseline to 6 months

• Mean Cost for Each Intervention

  6 months

Study Arms (3)

Motivational Interview

EXPERIMENTAL

Motivational interview provided by a clinical research nurse or physician.

Behavioral: Motivational Interview

Motivational Interview-Electronic

ACTIVE COMPARATOR

Motivational Interview provided by an interactive computer program.

Behavioral: Motivational Interview

Treatment as Usual

PLACEBO COMPARATOR

No intervention- resource list provided.

Other: Treatment as Usual

Interventions

Motivational Interview BEHAVIORAL

Motivational Interview provided by either a Nurse or Computer

Motivational Interview; Motivational Interview-Electronic

Treatment as Usual OTHER

Subjects given a brochure listing relevant recovery resources in the local area.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

Yale-New Haven Hospital- York St Campus

New Haven, Connecticut, 06510, United States

Location

Yale-New Haven Hospital-Chapel St Campus

New Haven, Connecticut, 06519, United States

Location

Related Publications (2)

• 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.

  PMID: 31100713 DERIVED

• 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.

  PMID: 30797381 DERIVED

MeSH Terms

Conditions

Alcoholism; Tobacco Use Disorder; Marijuana Abuse; Substance-Related Disorders

Interventions

Motivational Interviewing; Therapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

Results may not be generalizable to populations differing from population from which sample was drawn. Outcomes relied upon self-report, although we did try to verify through lab results for substance use and medical records/ provider for treatment.

Results Point of Contact

• Title: Kimberly A Yonkers
• Organization: Yale University School of Medicine

kimberly.yonkers@yale.edu

203-764-6621

Study Officials

• Kimberly A Yonkers, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Steve Martino, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants received a behavioral intervention that could not be masked. Outcome data were self report and urine tests rom the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2011
• First Posted: February 27, 2012
• Study Start: September 5, 2011
• Primary Completion: January 28, 2015
• Study Completion: January 28, 2015
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)