Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study (Native-CHOICES)
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|ClinicalTrials.gov Identifier: NCT03930342|
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Contraceptive Usage Alcohol Use Complicating Childbirth Alcohol Drinking||Behavioral: Native-CHOICES||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Women will be randomized 1:1 to the intervention or usual care conditions.|
|Official Title:||Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study|
|Actual Study Start Date :||March 28, 2019|
|Estimated Primary Completion Date :||March 14, 2022|
|Estimated Study Completion Date :||November 30, 2022|
Experimental: Native CHOICES Intervention
Native-CHOICES will comprise usual care plus 2 MI sessions delivered over 4 weeks; a contraception counseling session at a local clinic; and 3 months of electronic messaging to boost the effects of MI and counseling by increasing perceptions of social connection and social support for behavior change. Contraception counseling will be completed within 2 weeks after the second MI session, so the maximum duration of MI and counseling for each participant will be 6 weeks. Electronic messaging will include positive motivational content consistent with alcohol and contraception use goals set in the MI sessions.
Native CHOICES is a behavioral intervention for prevention of prenatal alcohol exposure in women at high risk for alcohol-exposed pregnancies. The intervention uses motivational interviewing and cognitive-behavioral strategies, and targets adoption of effective contraception and reduction of alcohol use.
No Intervention: Wait-list Control Group
The control condition will comprise usual care for the 6-month study period, with a wait-list design that offers women the Native- CHOICES program after they have completed the 6-month data collection.
- Reduction in alcohol exposed pregnancy [ Time Frame: Baseline, 6 weeks, 3 months and 6 months post intervention ]Our primary outcome is reduction in risk of alcohol exposed pregnancy, defined as no heavy or binge drinking or effective contraception use, or both.
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): NCT03930342
|Contact: Dedra Buchwald, MDfirstname.lastname@example.org|
|Contact: Odile Madesclaire, MPHemail@example.com|
|United States, South Dakota|
|Missouri Breaks Industries Research Inc||Recruiting|
|Eagle Butte, South Dakota, United States, 57625|
|Contact: Marcia O'Leary, BSN|
|Principal Investigator:||Dedra Buchwald, MD||Washington State University|