NCT00227903

Brief Summary

The purpose of this study is... To assess whether a behavioral treatment that combines motivational enhancement and cognitive skills training therapy (MET-CBT) is more effective than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g. marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using and dependent women; 2) decreasing HIV risk behavior; 3) improving birth outcomes (longer gestations and greater birth weight).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

August 21, 2013

Completed
Last Updated

April 15, 2020

Status Verified

April 1, 2020

Enrollment Period

5.9 years

First QC Date

September 27, 2005

Results QC Date

June 14, 2013

Last Update Submit

April 1, 2020

Conditions

Alcohol AbuseCocaine AbuseMarijuana Abuse

Outcome Measures

Primary Outcomes (6)

  • Percentage of Days Used Drugs or Alcohol

    intake to delivery, an average of 21 weeks

  • Percentage of Days Used Drugs or Alcohol

    delivery to 3 months post-delivery

  • Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol

    intake to delivery, an average of 21 weeks

  • Percentage of Days That Participants (Without a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol

    Delivery to 3 months post-delivery

  • Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol

    intake to delivery, an average of 21 weeks

  • Percentage of Days That Participants (With a Baseline Diagnosis of Drug Abuse or Dependence) Used Drugs or Alcohol

    Delivery to 3 months post-delivery

Secondary Outcomes (20)

  • Incidence of Preterm Births

    At delivery

  • Incidence of Low Birth Weight

    At delivery

  • Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report

    intake to delivery, an average of 21 weeks

  • Proportion of Participants Abstinent From Both Drugs and Alcohol (28 Days Prior to Assessment) According to Self-report

    Delivery to 3 months post-delivery

  • Proportion of Participants Abstinent From Drugs (i.e., Marijuana, Cocaine or Opioids) According to Urine

    intake to delivery, an average of 21 weeks

  • +15 more secondary outcomes

Other Outcomes (2)

  • Adequacy of Received Services

    After prenatal care initiation

  • Attendance of Treatment Outside the Study

    30 days prior to assessment

Study Arms (2)

MI-CBT

EXPERIMENTAL

Motivationally-enhanced cognitive behavioral skills counseling

Behavioral: MI-CBT

Brief Advice

ACTIVE COMPARATOR

Advice and education

Behavioral: Brief Advice

Interventions

MI-CBTBEHAVIORAL

Motivationally-enhanced cognitive behavioral skills counseling

MI-CBT
Brief AdviceBEHAVIORAL

Advice and education

Brief Advice

Eligibility Criteria

Age16 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pregnant women, age 16 or older, alcohol or illicit drug use in the past 30 days -

You may not qualify if:

  • Nonfluent in English or Spanish, pending incarceration, psychotic, cognitively unable to give informed consent, actively suicidal or homicidal, already engaged in addictions treatment, primarily addicted to nicotine or heroin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bridgeport Hospital

Bridgeport, Connecticut, 06106, United States

Location

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Related Publications (7)

  • Yonkers KA, Howell HB, Allen AE, Ball SA, Pantalon MV, Rounsaville BJ. A treatment for substance abusing pregnant women. Arch Womens Ment Health. 2009 Aug;12(4):221-7. doi: 10.1007/s00737-009-0069-2. Epub 2009 Apr 7.

    PMID: 19350369BACKGROUND

  • Hine CE, Howell HB, Yonkers KA. Integration of medical and psychological treatment within the primary health care setting. Soc Work Health Care. 2008;47(2):122-34. doi: 10.1080/00981380801970244.

    PMID: 18956504BACKGROUND

  • Yonkers KA, Gotman N, Kershaw T, Forray A, Howell HB, Rounsaville BJ. Screening for prenatal substance use: development of the Substance Use Risk Profile-Pregnancy scale. Obstet Gynecol. 2010 Oct;116(4):827-833. doi: 10.1097/AOG.0b013e3181ed8290.

    PMID: 20859145BACKGROUND

  • Quesada O, Gotman N, Howell HB, Funai EF, Rounsaville BJ, Yonkers KA. Prenatal hazardous substance use and adverse birth outcomes. J Matern Fetal Neonatal Med. 2012 Aug;25(8):1222-7. doi: 10.3109/14767058.2011.602143. Epub 2012 May 11.

    PMID: 22489543BACKGROUND

  • Yonkers KA, Forray A, Howell HB, Gotman N, Kershaw T, Rounsaville BJ, Carroll KM. Motivational enhancement therapy coupled with cognitive behavioral therapy versus brief advice: a randomized trial for treatment of hazardous substance use in pregnancy and after delivery. Gen Hosp Psychiatry. 2012 Sep-Oct;34(5):439-49. doi: 10.1016/j.genhosppsych.2012.06.002. Epub 2012 Jul 12.

    PMID: 22795046RESULT

  • Xu X, Yonkers KA, Ruger JP. Economic evaluation of a behavioral intervention versus brief advice for substance use treatment in pregnant women: results from a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Mar 7;17(1):83. doi: 10.1186/s12884-017-1260-5.

    PMID: 28270105DERIVED

  • Forray A, Gotman N, Kershaw T, Yonkers KA. Perinatal smoking and depression in women with concurrent substance use. Addict Behav. 2014 Apr;39(4):749-56. doi: 10.1016/j.addbeh.2013.12.008. Epub 2013 Dec 17.

    PMID: 24447885DERIVED

MeSH Terms

Conditions

AlcoholismCocaine-Related DisordersMarijuana Abuse

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Did not acheive desired sample size; results were averaged across substances; women were not seeking substance abuse treatment (i.e. they were attending for prenatal care); treatment was brief

Results Point of Contact

Title
Dr. Kimberly Yonkers
Organization
Yale University
Kimberly.Yonkers@yale.edu
1-203-764-6621

Study Officials

  • Kimberly A Yonkers, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 28, 2005

Study Start

September 1, 2004

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

April 15, 2020

Results First Posted

August 21, 2013

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

only aggregate de-identified data

Locations

US(2)