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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD065942 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Brown University | OTHER |
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The long-term objectives of this research are to develop effective treatments to reduce unplanned pregnancy and Sexually Transmitted Infections (STIs) for a highly under-served at-risk youth population.
This trial will evaluate a Motivational Interviewing (MI) intervention designed to improve contraceptive use and decrease STIs for at-risk youth for both those who do and do not want a pregnancy. Those interested in becoming pregnant will be counseled in the risks associated with teen pregnancy and what it means to have a healthy pregnancy and raise a child. The investigators will utilize Title X programs in Rhode Island to provide reproductive health services in the community. The investigators will recruit 250 at risk youth from RI Juvenile Probation Department (JPD), RI group homes and alternative schools, Job Corps of Rhode Island, and Community Mental Health Centers and randomize them to two interventions: two sessions of personalized MI or two sessions of Awareness for Sexual Health (ASH), both delivered individually by trained counselors. MI is based on the principles of the Transtheoretical Model (TTM) and on MI, an empirically supported counseling technique designed to enhance readiness to change targeted behaviors. ASH provides didactic information about contraception, STI prevention and abstinence, and is intended to control for the effects of assessment and attention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Intervention | Experimental | There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up. |
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| Didactic Educational Intervention | Active Comparator | There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Intervention | Behavioral | There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months. | Using the Timeline Followback (TLFB): Contraceptive use was measured via a calendar recall for both interventions.Continuous use of highly effective contraceptives at 9 Month follow up is determined if a participant remains on a highly effective contraceptive for 9 months. A participant switching from one highly effective contraceptive method to another is recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective. | 9 month follow-up |
| Number of Participants With a Positive STI Test After A Baseline Negative Test. | Conducted STI testing for T. vaginalis, N. gonorrhoeae, and C. trachomatis through urine specimen collection. If a participant is diagnosed with an STI at baseline the youth will be referred for treatment at a Title X clinic and will be retested at the next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection. | 9 month follow-up |
| Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months. | Using the Timeline Followback (TLFB): The types of contraceptives used was captured via a calendar recall for both interventions. Initiation of highly effective contraceptives is determined if a participant ever endorses beginning a highly effective contraceptive at any time within 9 months. | 9 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Positive Pregnancy Test After Baseline Assessment | The secondary outcome is pregnancy as documented by a positive pregnancy test by at follow-up visit. Pregnancy tests were administered by urine collection and Home Pregnancy Test sticks. | 9 month follow up |
| Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynda Stein, Ph.D. | University of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juvenile Probation | Cranston | Rhode Island | 02920 | United States | ||
| Exeter Job Corps |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34735198 | Derived | Delaney DJ, Stein LAR, Bassett SS, Clarke JG. Motivational interviewing for family planning and reducing risky sexual behavior among incarcerated men nearing release: A randomized controlled pilot study. Psychol Serv. 2023 Aug;20(3):538-552. doi: 10.1037/ser0000552. Epub 2021 Nov 4. |
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This project enrolled 272 at-risk females aged 14-21. Participants were eligible if they had sexual intercourse with a male partner in the past four months, were not pregnant and intended to have intercourse with a male in the next 6 months. Recruitment began in February of 2013 and the last participant was recruited in August of 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Motivational Intervention | There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up. Motivational Intervention: There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up. |
| FG001 | Didactic Educational Intervention | There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up. Didactic Educational Intervention: There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Motivational Intervention | There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up. Motivational Intervention: There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Continuous Use of Highly Effective Contraceptives Over 9 Months. | Using the Timeline Followback (TLFB): Contraceptive use was measured via a calendar recall for both interventions.Continuous use of highly effective contraceptives at 9 Month follow up is determined if a participant remains on a highly effective contraceptive for 9 months. A participant switching from one highly effective contraceptive method to another is recorded as maintaining continuous contraceptive use at follow-up if she switches methods during times when the original method is still effective. | Continuous use of highly effective birth control is defined as those who are using effective birth control for 6 months or more. Thus this analysis only includes participants who initiated effective birth control for at least 6 months of data collection. | Posted | Count of Participants | Participants | 9 month follow-up |
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Clients were assessed over a 9 month period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Motivational Intervention | There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up. Motivational Intervention: There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lynda Stein, Ph.D. | University of Rhode Island | 401-874-2830 | lmurphy@uri.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2023 | Jan 31, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D012749 | Sexually Transmitted Diseases |
| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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|
| Didactic Educational Intervention | Behavioral | There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up. |
|
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Using the Timeline Followback (TLFB): Condom use was measured via a calendar recall for both interventions. Participants indicate whether or not condoms were used each time sex was reported. |
| 9 month follow up |
| Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex. | Using the Timeline Follow-back (TLFB): Condom and substance use were measured via a calendar recall for both interventions. Participants indicate whether or not condoms and substances were used each time sex was reported. | 9 month follow-up |
| Exeter |
| Rhode Island |
| 02882 |
| United States |
| Family Services of Rhode Island (i.e. group homes) | Providence | Rhode Island | 02905 | United States |
| MET Schools (i.e., network of alternative schools throughout Providence and Newport) | Providence | Rhode Island | 02905 | United States |
| Community Care Alliance (i.e., Community Mental Health Center) | Woonsocket | Rhode Island | 02895 | United States |
| BG001 |
| Didactic Educational Intervention |
There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up. Didactic Educational Intervention: There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
There are two, 45-60 minute sessions of tailored Motivational Interviewing (MI). The first session occurs at the enrollment of the study, the second at 3 month follow-up. Motivational Intervention: There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up. |
| OG001 | Didactic Educational Intervention | There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up. Didactic Educational Intervention: There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up. |
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| Primary | Number of Participants With a Positive STI Test After A Baseline Negative Test. | Conducted STI testing for T. vaginalis, N. gonorrhoeae, and C. trachomatis through urine specimen collection. If a participant is diagnosed with an STI at baseline the youth will be referred for treatment at a Title X clinic and will be retested at the next follow-up visit. Any positive test after a baseline negative test will be documented as an incident infection. | Analysis conducted on all participants who provided a urine sample at baseline. 1 participant refused. | Posted | Count of Participants | Participants | 9 month follow-up |
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|
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| Primary | Number of Participants Who Initiated a Highly Effective Contraceptive Post Treatment in 9 Months. | Using the Timeline Followback (TLFB): The types of contraceptives used was captured via a calendar recall for both interventions. Initiation of highly effective contraceptives is determined if a participant ever endorses beginning a highly effective contraceptive at any time within 9 months. | Analysis conducted on participants who initiated highly effective contraceptive use post treatment intervention. Those who initiated highly effective contraceptives at baseline (pre treatment) were not included in this analysis. | Posted | Count of Participants | Participants | 9 month follow up |
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|
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| Secondary | Number of Participants With a Positive Pregnancy Test After Baseline Assessment | The secondary outcome is pregnancy as documented by a positive pregnancy test by at follow-up visit. Pregnancy tests were administered by urine collection and Home Pregnancy Test sticks. | Posted | Count of Participants | Participants | 9 month follow up |
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|
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| Secondary | Number of Participants Who Used Condoms 100% of the Time Thus Reducing the Risk of STIs. | Using the Timeline Followback (TLFB): Condom use was measured via a calendar recall for both interventions. Participants indicate whether or not condoms were used each time sex was reported. | Not Posted | Nov 2025 | 9 month follow up | Participants |
| Secondary | Number of Participants Who Reported Any Occasion of Substance Use and no Condom Use at the Time of Sex. | Using the Timeline Follow-back (TLFB): Condom and substance use were measured via a calendar recall for both interventions. Participants indicate whether or not condoms and substances were used each time sex was reported. | Not Posted | Nov 2025 | 9 month follow-up | Participants |
| 0 |
| 142 |
| 0 |
| 142 |
| 0 |
| 142 |
| EG001 | Didactic Educational Intervention | There are two, 45-60 minute sessions of didactic educational intervention related to promoting awareness for sexual health involving contraception and STI prevention. The first session occurs at the enrollment of the study, the second at 3 month follow-up. Didactic Educational Intervention: There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up. | 0 | 130 | 0 | 130 | 0 | 130 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |