Pilot Clinical Trial of Computer-based Motivational Intervention - 1

Substance-Related Disorders Clinical Trial

Official title:

Pilot Clinical Trial of Computer-based Motivational Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230022
• Other study ID #: NIDA-14621-1
• Secondary ID: R21DA014621
• Status: Completed
• Phase: Phase 1
• First received: September 29, 2005
• Last updated: June 10, 2013
• Start date: October 2004
• Est. completion date: April 2005

Study information

• Verified date: June 2013
• Source: Wayne State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Pilot trial of computer-based motivational intervention. Hypothesis: The brief computer-delivered intervention would result in higher motivation to change at follow-up.

Description:

Participants were randomized into brief intervention vs. assessment-only conditions, with follow-up to measure overall motivation to change.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Woman in immediate post-partum period

Inclusion Criteria:

Self-report of drug use prior to pregnancy

Exclusion Criteria:

Frank psychosis or other cognitive impairment; inability to communicate in English; fatigue; recent receipt of narcotic pain medication; grieving over medically compromised infant

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-Related Disorders

Intervention

Behavioral:
• Brief computer-delivered intervention
20-minute interaction with voice-enabled software that could provide reflections, images, text, etc.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Wayne State University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ondersma SJ, Chase SK, Svikis DS, Schuster CR. Computer-based brief motivational intervention for perinatal drug use. J Subst Abuse Treat. 2005 Jun;28(4):305-12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Motivation to Change Substance Use	An eight-item measure tapping motivation to change, self-efficacy, and change intention was assessed using visual analog scales. The average of the eight items was calculated resulting in a score ranging from 1 to 100. The measure was asked at baseline (reported in baseline data) and the one month follow-up. Scores here represent average level of motivation for change at the time of follow-up. Higher scores represent higher levels of motivation to change, self-efficacy and intention to change.	One month	No