An interventional study of Brief Intervention (BI) with Technology Extender and Brochure in Alcohol and Substance-Related Mental Disorders and Sexually Transmitted Diseases, sponsored by The Miriam Hospital. Completed at 1 site in United States. Open to female participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-07.
Sponsored by The Miriam Hospital · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
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.
Behavioral: Brief Intervention (BI) with Technology Extender
Participants assigned to the Brochure condition will receive materials prepared by the Centers for Disease Control and Prevention on the study topics.
Other: Brochure
One, 45-60 minute BI, followed by three months of access to technology extenders
Brochures provided one time
Feasibility of Providing Intervention
percentage of individuals who attended their intervention
Time frame: Immediately following intervention session (post-intervention), up to 30 minutes
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.
Time frame: Immediately following intervention session (post-intervention), up to 30 minutes
Number of Sexual Partners
The number of male partners that the participant reported having penetrative sex with.
Time frame: 3-month Follow-up
Condomless Sex
The number of occasions of condomless sex
Time frame: 3-month Follow-up
Alcohol Use Quantity
The average number of drinks in a week
Time frame: 3-month Follow-up
Alcohol Use Binge Frequency
The number of drinking occasions (single day) when 4 or more drinks are consumed
Time frame: 3-month Follow-up
| Milestone | Brief Intervention (BI) With Technology Extender | Brochure |
|---|---|---|
| Started | 26 | 22 |
| Completed | 23 | 20 |
| Not completed | 3 | 2 |
| Withdrew: Lost to follow-up | 3 | 2 |
percentage of individuals who attended their intervention
| Participants | Brief Intervention (BI) With Technology Extender | Brochure |
|---|---|---|
| Feasibility of Providing Intervention | 25 | 22 |
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.
| units on a scale | Brief Intervention (BI) With Technology Extender | Brochure |
|---|---|---|
| Session Evaluation Questionnaire | 4.65 ± 0.36 | 3.98 ± 0.96 |
The number of male partners that the participant reported having penetrative sex with.
| partners | Brief Intervention (BI) With Technology Extender | Brochure |
|---|---|---|
| Number of Sexual Partners | 3.23 ± 3.22 | 4.00 ± 3.08 |
The number of occasions of condomless sex
| events of condomless sex | Brief Intervention (BI) With Technology Extender | Brochure |
|---|---|---|
| Condomless Sex | 3 (2 to 4) | 5 (4 to 6) |
The average number of drinks in a week
| drinks per week | Brief Intervention (BI) With Technology Extender | Brochure |
|---|---|---|
| Alcohol Use Quantity | 3.23 ± 3.22 | 4.00 ± 3.08 |
The number of drinking occasions (single day) when 4 or more drinks are consumed
| heavy episodic drinking days | Brief Intervention (BI) With Technology Extender | Brochure |
|---|---|---|
| Alcohol Use Binge Frequency | 2.36 ± 3.27 | 2.00 ± 2.00 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brief Intervention (BI) With Technology Extender | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Brochure | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Brief Intervention (BI) With Technology Extender | Brochure | Total |
|---|---|---|---|
| Mean | 21.28 ± 2.61 | 24.33 ± 2.92 | 22.67 ± 3.13 |
| Sex: Female, Male(Participants) | Brief Intervention (BI) With Technology Extender | Brochure | Total |
|---|---|---|---|
| Female | 26 | 22 | 48 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Brief Intervention (BI) With Technology Extender | Brochure | Total |
|---|---|---|---|
| Hispanic or Latino | 8 | 6 | 14 |
| Not Hispanic or Latino | 17 | 15 | 32 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Brief Intervention (BI) With Technology Extender | Brochure | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 16 | 12 | 28 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 4 | 2 | 6 |
| Region of Enrollment(participants) | Brief Intervention (BI) With Technology Extender | Brochure | Total |
|---|---|---|---|
| United States | 26 | 22 | 48 |
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The Miriam Hospital