Clinical Trials Directory

Trials / Completed

CompletedNCT00227903

Therapeutic Substance Abuse Treatment in Pregnancy - 1

Psychosocial Research to Improve Drug Treatment in Pregnancy (PRIDE-P)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
168 (actual)
Sponsor
Yale University · Academic / Other
Sex
Female
Age
16 Years – 45 Years
Healthy volunteers
Not accepted

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).

Detailed description

We propose an integrated system of counseling services onsite in primary care obstetrical clinics, comparing a manualized brief advice (closely approximating "treatment as usual") to manualized motivationally enhanced cognitive behavioral therapy. Treatment providers are obstetrical nurses. Therapy patients are taught skill sets designed to enhance motivation to abstain from drugs of abuse, as well as designed to prevent relapse during the perinatal period. It is our hypothesis that therapy patients will be more successful at achieving stated study aims than those receiving brief advice.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMI-CBTMotivationally-enhanced cognitive behavioral skills counseling
BEHAVIORALBrief AdviceAdvice and education

Timeline

Start date
2004-09-01
Primary completion
2010-08-01
Completion
2010-08-01
First posted
2005-09-28
Last updated
2020-04-15
Results posted
2013-08-21

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00227903. Inclusion in this directory is not an endorsement.