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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA023158 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Planned Parenthood of Southern New England | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This study will investigate whether BI and technology extenders are feasible and acceptable for female patients at a reproductive health center (ages 18-29).
This study will assess the feasibility and acceptability, and obtain initial evidence of the efficacy, of the BI and technology extenders. At-risk women drinkers (N = 50) recruited from a reproductive health care clinic will be assessed, randomly assigned to the integrated BI or control (a Centers for Disease Control and Prevention-produced brochure with information about alcohol and women's health), and reassessed at 3 months to determine impact on alcohol use, condom use, and number of partners as well as hypothesized mediators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Intervention (BI) with Technology Extender | Experimental | Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics. |
|
| Brochure | Other | Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Intervention (BI) with Technology Extender | Behavioral | One, 45-60 minute BI, followed by three months of access to technology extenders |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Providing Intervention | percentage of individuals who attended their intervention | Immediately following intervention session (post-intervention), up to 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Session Evaluation Questionnaire | Measure Name: Session Evaluation Questionnaire; Construct Assessed: Treatment Satisfaction; Minimum total scale score = 1; Maximum total scale score = 5; Scoring: averaged ratings across 4 items; Interpretation: Higher scores represent a better outcome. | Immediately following intervention session (post-intervention), up to 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
sex assigned at birth
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Carey, PhD | The Miriam Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Planned Parenthood of Southern New England | Providence | Rhode Island | 02906 | United States |
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50 women enrolled in the trial. Two women who enrolled withdrew prior to randomization. Thus, 48 women were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Brief Intervention (BI) With Technology Extender | Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics. Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders |
| FG001 | Brochure | Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics. Brochure: Brochures provided one time |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Brief Intervention (BI) With Technology Extender | Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics. Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Feasibility of Providing Intervention | percentage of individuals who attended their intervention | 50 patients enrolled. 2 patients withdrew prior to randomization. Leaving 48 participants for this analysis. | Posted | Count of Participants | Participants | Immediately following intervention session (post-intervention), up to 30 minutes |
|
3 months
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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 | Brief Intervention (BI) With Technology Extender | Participants assigned to BI condition will receive a face to face session lasting 45-60 minutes delivered by a health coach. Following the session, participants will be given access to a study website and receive texts-of-the day on study topics. Brief Intervention (BI) with Technology Extender: One, 45-60 minute BI, followed by three months of access to technology extenders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael Carey | The Miriam Hospital | 401 793 8218 | michael_carey@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 28, 2018 | Dec 6, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2018 | Dec 6, 2019 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 4, 2017 | Dec 6, 2019 | ICF_002.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 |
|---|---|
| D003419 | Crisis Intervention |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Brochure | Other | Brochures provided one time |
|
| Number of Sexual Partners | The number of male partners that the participant reported having penetrative sex with. | 3-month Follow-up |
| Condomless Sex | The number of occasions of condomless sex | 3-month Follow-up |
| Alcohol Use Quantity | The average number of drinks in a week | 3-month Follow-up |
| Alcohol Use Binge Frequency | The number of drinking occasions (single day) when 4 or more drinks are consumed | 3-month Follow-up |
| BG001 | Brochure | Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics. Brochure: Brochures provided one time |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Brochure |
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics. Brochure: Brochures provided one time |
|
|
| Secondary | Session Evaluation Questionnaire | Measure Name: Session Evaluation Questionnaire; Construct Assessed: Treatment Satisfaction; Minimum total scale score = 1; Maximum total scale score = 5; Scoring: averaged ratings across 4 items; Interpretation: Higher scores represent a better outcome. | 50 patients enrolled. However, 2 patients withdrew prior to randomization and 2 withdrew post-randomization leaving a total of 46 patients who provided data at this post-intervention assessment. | Posted | Mean | Standard Deviation | units on a scale | Immediately following intervention session (post-intervention), up to 30 minutes |
|
|
|
| Secondary | Number of Sexual Partners | The number of male partners that the participant reported having penetrative sex with. | 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment. | Posted | Mean | Standard Deviation | partners | 3-month Follow-up |
|
|
|
| Secondary | Condomless Sex | The number of occasions of condomless sex | 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment. | Posted | Median | 99% Confidence Interval | events of condomless sex | 3-month Follow-up |
|
|
|
| Secondary | Alcohol Use Quantity | The average number of drinks in a week | 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment. | Posted | Mean | Standard Deviation | drinks per week | 3-month Follow-up |
|
|
|
| Secondary | Alcohol Use Binge Frequency | The number of drinking occasions (single day) when 4 or more drinks are consumed | 50 patients enrolled. However, 2 patients withdrew prior to randomization, 2 withdrew post-randomization, and 3 were lost to follow-up, leaving a total of 43 patients who provided data at this 3-month follow-up assessment. | Posted | Mean | Standard Deviation | heavy episodic drinking days | 3-month Follow-up |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | Brochure | Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics. Brochure: Brochures provided one time | 0 | 22 | 0 | 22 | 0 | 22 |
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |