Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151151
Status:
COMPLETED
Last Update Posted:
2011-09-13
First Post:
2005-09-06
Brief Title:
The SAFE Study Computer-Aided Counseling to Prevent Teen PregnancySexually Transmitted Diseases STDs
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
The SAFE Study Computer-Aided Counseling to Prevent Teen PregnancySTDs - Validity and Reliability Testing of Computer Measures Pilot-testing of Timeline Followback Calendar Protocol and Randomized Efficacy Study
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized clinical trial assessing the efficacy of two types of counseling Computer-Assisted Motivational Intervention CAMI versus Didactic Educational Counseling DEC to see which can better reduce female adolescents risk taking behaviors that put them at risk for unintended pregnancy and sexually transmitted diseases STDs The intervention phase consists of three 30-minute counseling sessions over the first 6 months followed by a visit every three months during the 12 month follow up phase We the researchers hypothesize that the CAMI will decrease the proportion of subjects who engage in any intercourse that is poorly protected against pregnancy and against STDs
Detailed Description:
Adolescent unintended pregnancy and STDs remain at epidemic levels in the United States Healthy People 2010 Objectives set a goal to increase to 90 the proportion of sexually active adolescents who use contraception that both effectively prevents pregnancy and provides barrier protection against disease How to effectively counsel adolescents to reach this goal is unclear Counseling and feedback based on the Transtheoretical Model TTM have demonstrated greater success than standard action-oriented advice in several domains of behavior change The effectiveness of this type of counseling to alter female adolescents sexual and contraceptive behaviors has not been rigorously evaluated We propose recruiting 660 female adolescents ages 13 to 21 years from an inner-city hospital-based clinic and randomizing them to either an innovative Computer-Assisted Motivational Intervention CAMI or a Didactic Educational Control DEC The CAMI group will receive three 30-minute sessions of one-on-one counseling with a counselor that is guided by computer-generated personalized feedback The CAMI is based on the principles of the TTM and on Motivational Interviewing The DEC provides three 30-minute sessions of one-on-one didactic information on contraception STD prevention and abstinence The two interventions are identical in length and timing but vary in educational content counseling style and the provision of personalized feedback We will track the two groups of female adolescents in this study through a 6-month intervention phase and a 12-month follow-up phase to assess differences in sexual and contraceptive behaviors by group The primary specific aim for the study is to evaluate the efficacy of the CAMI as compared to the DEC in reducing sexual behaviors that increase the risks of both unintended pregnancy and STDs We will examine protective sexual behaviors in three ways 1 behaviors that protect against pregnancy 2 behaviors that protect against STDs and 3 behaviors that protect against both pregnancy and STDs Our primary hypothesis is that the CAMI will decrease the proportion of subjects who engage in any intercourse that is poorly protected against pregnancy and against STDs We also predict that among sexually active subjects the CAMI will increase the percentage of episodes of intercourse that are well protected by the use of both condoms plus another contraceptive Finally we also predict that the CAMI will increase the prevalence of abstinence among the entire sample If proven effective computer-assisted personalized motivational counseling could be broadly implemented as a method to decrease the incidence of unintended pregnancy and STDs among female adolescents
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HD41058 | None | None | None |