Indirect Assessment and Intervention for Perinatal Drug Use
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|ClinicalTrials.gov Identifier: NCT01650675|
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : December 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Drug Abuse||Behavioral: WIDUS computer-delivered, indirect brief intervention Behavioral: Nutrition time control/placebo intervention||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Indirect Assessment and Intervention for Perinatal Drug Use|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||May 2015|
Placebo Comparator: Control
Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.
Behavioral: Nutrition time control/placebo intervention
This time-control intervention, designed in part to help promote RA blinding as to participant condition, focuses on proper infant nutrition using a computer-delivered, interactive format and videos.
Experimental: Indirect intervention
Participants in this condition review a short series of parenting strengths that benefit infants, and are invited to consider their current status in each area. This list includes factors associated with drug use (e.g., safety, emotional health) as well as substance use itself.
Behavioral: WIDUS computer-delivered, indirect brief intervention
A single 20-minute interactive computer-delivered intervention designed to promote motivation to change drug use and risky sexual behavior, if any, without presuming those risks to be specifically present.
- Number of drug using days [ Time Frame: since last research visit; up to 90 days prior to current evaluation ]Drug use over past 90 days will be measured at a 3 and 6-month follow-up by self-report, hair, and urine analysis.
- Change from Baseline HIV and other STI risk at 3 months [ Time Frame: since last research visit; up to 90 days from baseline visit ]Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs
- Change from Baseline in HIV and Other STI Risk at 6 months [ Time Frame: since last research visit; up to 180 days since baseline visit ]Self-report of risky sexual and/or injection drug use that could place participants at risk of HIV and other STIs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650675
|United States, Michigan|
|Wayne State University|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Steven J Ondersma, Ph.D.||Wayne State University|