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
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | MI-CBT | Motivationally-enhanced cognitive behavioral skills counseling |
| BEHAVIORAL | Brief Advice | Advice 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.