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| Name | Class |
|---|---|
| Virtually Better, Inc. | INDUSTRY |
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Teenagers in mental health treatment are at greater risk for HIV and other sexually transmitted infections. This greater risk comes from many factors, some of which are related to poor emotion regulation and low self-confidence. There is a need for an HIV prevention program specifically for these at-risk teens. The goal of this study is to develop a computerized HIV prevention study tailored to adolescents in mental health treatment. The first part of the study will develop core sessions of D*STAR. It will do this by using focus group feedback from approximately 15 adolescents in mental health treatment, and approximately 10 parents of youth in mental health treatment and mental health treatment center staff. Feedback on D*STAR prototype sessions will also be collected from two individual interviews with approximately 15 youth in mental health treatment. Core sessions will then be reviewed in an open trial with approximately 30 adolescents.
The second part of the study will develop and refine digital versions of the remaining sessions of STAR and a digital general health promotion intervention. It will do this by using focus group feedback from approximately 20 adolescents in mental health treatment, and approximately 10 community advisory board members which include variety of staff from mental health treatment settings such as administrators, supervisors, therapists, health teachers at therapeutic schools, clinicians at day hospitals and day treatment programs, parents of youth in mental health treatment and from relevant community organizations, such as those serving lesbian, gay, bisexual, transgender, and questioning youth. Feedback on D*STAR prototype sessions will also be collected from two individual interviews with approximately 20 youth in mental health treatment. All developed sessions (from both Phase I and Phase II) will then be reviewed in an open trial with approximately 20 adolescents. A randomized control trial (RCT) will then be conducted to compare D*STAR to a time matched digital general health promotion intervention among approximately 120 adolescents. For the pilot and RCT phases, assessments will be administered prior to randomization, immediately following the last intervention session, and at one month post-intervention (pilot study) or at three month post-intervention (RCT).
Adolescents in mental health treatment are at greater risk for HIV and other STIs than their peers due to an earlier age of onset of sex, less protected sex, more sexual partners, and more frequent substance use. The numerous adolescents who receive mental health treatment do so in a variety of settings such as day hospital programs, therapeutic schools and residential centers. These programs offer a variety of health services but there is no efficacious HIV prevention program specifically tailored for the issues of youth in mental health treatment, other than the one described in this project. STAR ("Safe Thinking and Affect Regulation"). The goal of this SBIR (Small Business Innovation Research) Fast-Track project is to transform STAR into an engaging digital, multimedia format, Digital STAR (D*STAR), for easy and reliable use by care agencies that serve adolescents in mental health treatment. To transform this intervention, Virtually Better, a company with a successful history of production and distribution of cutting-edge technological interventions, has teamed with the research developers of STAR at Rhode Island Hospital and Brown University. During the two phases of this Fast-Track project, digital session development will be accomplished by an iterative process of feedback and refinement between Virtually Better, the developers of STAR, adolescents in mental health treatment, and a Community Advisory Board.
Phase 1: Specific Aims A. To develop and refine digital versions of core sessions of STAR that introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education. These sessions represent essential content areas and modalities of the D*STAR intervention.
B. To conduct focus groups of the feasibility, utility, and acceptability of the planned sessions. There will be focus groups with approximately 10 Community Advisory Board (CAB) members comprised of parents of youth in mental health treatment and mental health treatment staff. There will also be focus groups with approximately 15 adolescents in mental health treatment (13-18 years old) .
C. To conduct two qualitative interview sessions of approximately 15 youth with mental health treatment to determine the acceptability of the session's prototypes and revise based on feedback.
D. To conduct an open trial of D*STAR sessions with approximately 30 adolescents to determine its preliminary impact with self-report assessments at baseline and then 1 month post intervention.
Phase 2: Specific Aims A. To develop and refine digital versions the remaining sessions of STAR and a digital general health promotion (HP) intervention, building upon the essential content areas and refinements developed in Phase I.
B. To conduct qualitative evaluations of the feasibility, utility, and acceptability of D*STAR and the digital HP intervention with adolescents in mental health treatment, our Community Advisory Board (CAB), and mental health treatment center staff.
Hypothesis: Both digital interventions (HP and D*STAR) will be rated by youth, our CAB, and mental health treatment center staff as enjoyable, useful and easy to implement.
C. To conduct a randomized control trial of D*STAR compared to the time matched digital HP intervention among 120 adolescents ages 13 to 18 in mental health treatment.
Hypothesis: Participants in D*STAR will report safer sexual behaviors, greater HIV knowledge and greater self-efficacy for HIV prevention skills than participants in digital HP at three months follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DSTAR | Experimental | Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education. |
|
| DHEALTH | Active Comparator | Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D*STAR | Behavioral |
| ||
| D*HEALTH |
| Measure | Description | Time Frame |
|---|---|---|
| HIV Knowledge | HIV Knowledge Questionnaire. A 18-item (true, false, uncertain) scale surveys routes of transmission, casual contact misconceptions, general information and course of illness. Scores range from 0-18 with higher scores indicating greater HIV knowledge. | 3 months post-intervention |
| Self-efficacy for HIV Prevention | The scale contains 13 items that reflect the context of condom use, such as "could use a condom when I'm very upset". Scores range from 13 to 52 with higher scores indicated lower self-efficacy for HIV prevention. | 3 months post-intervention |
| Lifetime Sexual Intercourse | Lifetime oral, vaginal, and/or anal sex | 3-months post-intervention |
| Recent Oral, Vaginal, and/or Anal Sex | Oral, vaginal, and/or anal sex in the past 3 months | 3-months post-intervention |
| Frequency of Sexual Intercourse | Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months. | 3-months post-intervention |
| Number of Sexual Partners | Number of sexual partners in the past 3 months. | 3-months post-intervention |
| Frequency of Condom Use | Number of times a condom was used during oral, vaginal, and/or anal sex | 3-months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Affect Dysregulation Scale | A six-item scale assessing adolescents' perceived abilities to manage emotional upset (e.g., "In the past three months, I have had trouble controlling my feelings.") in sexual situations. Scores range from 6 to 24 with higher scores indicated poorer perceived ability to manage emotional upset in sexual situations. | 3 months post-intervention (average 6 months) |
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Inclusion Criteria:
Adolescent males and females ages 13 to 20 years who are in mental health treatment will be eligible for enrollment in each phase of study according to the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margo Adams Larsen, PhD | Virtually Better, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21961780 | Background | Brown LK, Nugent NR, Houck CD, Lescano CM, Whiteley LB, Barker D, Viau L, Zlotnick C. Safe Thinking and Affect Regulation (STAR): human immunodeficiency virus prevention in alternative/therapeutic schools. J Am Acad Child Adolesc Psychiatry. 2011 Oct;50(10):1065-74. doi: 10.1016/j.jaac.2011.06.018. Epub 2011 Aug 27. | |
| Background | CDC. Estimated HIV incidence in the United States, 2007-2010, HIV Surveillance Supplemental Report, 2012. Accessed from: http://www.cdc.gov/hiv/topics/surveillance/resources/reports/#supplemental. | ||
| Background | UNAIDS. UNAIDS World AIDS Day Report, 2011, Accessed from: http://www.unaids.org/en/resources/documents/2011/20111121_JC2216_WordAIDSday_report_2011 | ||
| Background | CDC. 2008 Sexually Transmitted Disease Surveillance. 2009. Accessed from: http://www.cdc.gov/std/stats08/default.htm |
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| ID | Title | Description |
|---|---|---|
| FG000 | DSTAR | Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education. |
| FG001 | DHEALTH | Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DSTAR | Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education. |
| BG001 | DHEALTH |
| 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 | HIV Knowledge | HIV Knowledge Questionnaire. A 18-item (true, false, uncertain) scale surveys routes of transmission, casual contact misconceptions, general information and course of illness. Scores range from 0-18 with higher scores indicating greater HIV knowledge. | Missing data accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | score on a scale | 3 months post-intervention |
|
Up to 5 months
Adverse events as described in the study protocol were reported by study staff to the principle investigator.
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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 | DSTAR | Digital HIV Prevention intervention developed to specifically address the needs of youth in mental health treatment. Sessions introduce affect regulation and cognitive monitoring in sexual situations, and provide basic sexual health skills and education. |
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This study had a small sample. Participants were recruited from alternative schools across Rhode Island which may not be representative of all adolescents that attend alternative schools.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Larry K. Brown, MD | Rhode Island Hospital | (401) 793 - 8808 | lkbrown@lifespan.org |
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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 | Apr 16, 2019 | Dec 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included. |
|
| Condom Use Intention | On a scale of 0 to 100, participants report how likely it is that they will use a condom when they have sex in the next 3 months. Zero represented "I will not use a condom", "50" represented "I will use a condom half the time.", and "100" represented "I will use a condom all the time.". | 3-months post-intervention |
| Recent Alcohol Use | Alcohol use in the past 30 days (yes/no) | 3-months post-intervention |
| Frequency of Recent Alcohol Use | Number of days alcohol was used in the past 30 days | 3-months post-intervention |
| Quantity of Recent Alcohol Use | Number of drinks reported on days that a participant drank alcohol in the past 30 days | 3-months post-intervention |
| Recent Marijuana Use | Marijuana use in the past 30 days (yes/no) | 3-months post-intervention |
| Frequency of Recent Marijuana Use | Number of days marijuana was used in the past 30 days | 3-months post-intervention |
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Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| History of Arrest | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
| School Lunch Price | Count of Participants | Participants |
|
Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included. |
|
|
| Primary | Self-efficacy for HIV Prevention | The scale contains 13 items that reflect the context of condom use, such as "could use a condom when I'm very upset". Scores range from 13 to 52 with higher scores indicated lower self-efficacy for HIV prevention. | Missing data accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | score on a scale | 3 months post-intervention |
|
|
|
| Primary | Lifetime Sexual Intercourse | Lifetime oral, vaginal, and/or anal sex | Posted | Count of Participants | Participants | 3-months post-intervention |
|
|
|
| Primary | Recent Oral, Vaginal, and/or Anal Sex | Oral, vaginal, and/or anal sex in the past 3 months | Missing data accounts for the discrepancies in the analytic sample for this measure. | Posted | Count of Participants | Participants | 3-months post-intervention |
|
|
|
| Primary | Frequency of Sexual Intercourse | Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months. | Restricted to those that were sexually active in the past 3 months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in analytic sample for this measure. | Posted | Mean | Standard Deviation | sexual acts | 3-months post-intervention |
|
|
|
| Primary | Number of Sexual Partners | Number of sexual partners in the past 3 months. | Restricted to those that were sexually active in the past 3 months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | sexual partners | 3-months post-intervention |
|
|
|
| Primary | Frequency of Condom Use | Number of times a condom was used during oral, vaginal, and/or anal sex | Restricted to those who were sexually active in the past three months at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | times a condom was used | 3-months post-intervention |
|
|
|
| Primary | Condom Use Intention | On a scale of 0 to 100, participants report how likely it is that they will use a condom when they have sex in the next 3 months. Zero represented "I will not use a condom", "50" represented "I will use a condom half the time.", and "100" represented "I will use a condom all the time.". | Missing data accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | units on a scale | 3-months post-intervention |
|
|
|
| Primary | Recent Alcohol Use | Alcohol use in the past 30 days (yes/no) | Posted | Count of Participants | Participants | 3-months post-intervention |
|
|
|
| Primary | Frequency of Recent Alcohol Use | Number of days alcohol was used in the past 30 days | Restricted to those that indicated alcohol use in the past 30 days at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | days | 3-months post-intervention |
|
|
|
| Primary | Quantity of Recent Alcohol Use | Number of drinks reported on days that a participant drank alcohol in the past 30 days | Restricted to those that indicated alcohol use in the past 30 days at the 3-month post-intervention follow-up. Missing data also accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | alcoholic drinks | 3-months post-intervention |
|
|
|
| Primary | Recent Marijuana Use | Marijuana use in the past 30 days (yes/no) | Missing data accounts for the discrepancy in analytic sample for this measure. | Posted | Count of Participants | Participants | 3-months post-intervention |
|
|
|
| Primary | Frequency of Recent Marijuana Use | Number of days marijuana was used in the past 30 days | Restricted to those that indicated marijuana use in the past 30 days at the 3-month post-intervention follow-up. | Posted | Mean | Standard Deviation | days | 3-months post-intervention |
|
|
|
| Secondary | Affect Dysregulation Scale | A six-item scale assessing adolescents' perceived abilities to manage emotional upset (e.g., "In the past three months, I have had trouble controlling my feelings.") in sexual situations. Scores range from 6 to 24 with higher scores indicated poorer perceived ability to manage emotional upset in sexual situations. | Missing data accounts for the discrepancy in the analytic sample for this measure. | Posted | Mean | Standard Deviation | score on a scale | 3 months post-intervention (average 6 months) |
|
|
|
| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
| EG001 | DHEALTH | Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included. | 0 | 57 | 0 | 57 | 0 | 57 |
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |