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Digital Star: HIV Prevention for Youth in Mental Health Treatment (DSTAR)

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ClinicalTrials.gov Identifier: NCT02921841
Recruitment Status : Completed
First Posted : October 3, 2016
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Virtually Better, Inc.
Information provided by (Responsible Party):
Dr. Larry K. Brown, Rhode Island Hospital

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Mental Health Behavioral: D*STAR Behavioral: D*HEALTH Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Digital Star: HIV Prevention for Youth in Mental Health Treatment
Study Start Date : November 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: D*STAR
Active Comparator: 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.
Behavioral: D*HEALTH
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 Outcome Measures :
  1. Sexual Behaviors [ Time Frame: Baseline, 3-months post-intervention (an average of 6 months) ]
    The Adolescent Risk Behavior Assessment (ARBA) is a computer-assisted structured interview designed specifically for use with adolescents to assess their self-reported sexual and drug behaviors associated with HIV infection. HIV-Related Behavior. Sexual-risk questions ask about type of sexual behavior lifetime and in past three months (i.e., anal, oral, vaginal), frequency of sexual intercourse, age of sexual debut, number of sexual partners and frequency of condom use, and condom use intentions in the next 3 months. Questions ask about alcohol and marijuana use including frequency and quantity.

  2. Greater HIV knowledge/attitudes [ Time Frame: Baseline, 8-weeks, 3 months post-intervention (an average of 6 months) ]
    A twenty-item (true, false, uncertain) scale surveys routes of transmission, casual contact misconceptions, general information and course of illness.

  3. Greater Self-efficacy for HIV prevention skills [ Time Frame: Baseline, 8-weeks, 3 months post-intervention (an average of 6 months) ]
    The scale contains 13 items that reflect the context of condom use, such as "could use a condom when I'm very upset" and was found to have a good factor structure and a strong alpha of 0.9.(87) Self-efficacy in emotionally stressful situations improved in STAR, presumably due to the improvement in affect management.


Secondary Outcome Measures :
  1. Affect Dysregulation Scale [ Time Frame: Baseline, 3 months post-intervention (average 6 months) ]
    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." The scale has a Cronbach's alpha =.72. The scale correlates strongly with behavioral risk in a sample of youth in mental health treatment.



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Ages Eligible for Study:   13 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  1. English speaking,
  2. adolescent assent given to participate in the study,
  3. consent of a parent/legal guardian and HIPAA research authorization permission and
  4. attending an alternative / therapeutic school, mental health day treatment program, partial hospital program, or therapeutic group homes.

Exclusion Criteria:

  1. self-report of HIV infection (STAR is not designed to address disclosure, stigma, and medical adherence issues),
  2. recent or current pregnancy,
  3. cognitive limitation that impairs consent capacity by judgment of clinical staff and
  4. current participation in another psychosocial intervention that is addressing STI/HIV prevention.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921841


Locations
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United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Rhode Island Hospital
Virtually Better, Inc.
Investigators
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Principal Investigator: Margo Adams Larsen, PhD Virtually Better, Inc.

Publications:
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.
UNAIDS. UNAIDS World AIDS Day Report, 2011, Accessed from: http://www.unaids.org/en/resources/documents/2011/20111121_JC2216_WordAIDSday_report_2011
CDC. 2008 Sexually Transmitted Disease Surveillance. 2009. Accessed from: http://www.cdc.gov/std/stats08/default.htm
Kaiser Family Foundation. Medicare and HIV/AIDS Fact Sheet. February, 2009. Accessed from: http://www.kff.org/hivaids/7171.cfm
CDC. Projecting Possible Future Courses of the HIV Epidemic in the United States. 2010. Accessed from: https://npin.cdc.gov/publication/projecting-possible-future-courses-hiv-epidemic-united-states
Jessor R, Jessor S. Problem behavior and psychosocial development: A longitudinal study of youth. New York: Academic Press; 1977.
Martin S, Oppenheim K. Video gaming: General and pathological use. Trends & Tudes. 2008; 6(1):1-6.
St. Lawrence S, Crosby A, Belcher L, et al. Sexual risk reduction and anger management interventions for incarcerated male adolescents: A randomized controlled trial of two interventions. Journal of Sex Education and Therapy. 1999; 24(1&2): 9-17.
Linehan MM. Skills training manual for treating borderline personality disorder. New York, NY: Guilford Press; 1993.
Beck J. Cognitive Therapy: Basics and Beyond. New York, N.Y: Guilford; 1995.
Wilson D, Bouffard L, MacKenzie D. A quantitative review of structured, group-oriented, cognitive-behavioral programs for offenders. Journal of Criminal Justice and Behavior. 2005; 32(2):172-204.
Krueger R, Casey M. Focus groups: A Practical Guide for Applied Research (3rd edition.) Thousand Oaks, CA: Sage; 2000.
Harper G, Contreras R, Bangi A, Pedraza A. Collaborative process evaluation: Enhancing community relevance and cultural appropriateness in HIV prevention. Journal of Prevention and Intervention in the Community. 2003; 26(2):53-71.
Brown L, Hadley W, Donenberg G, DiClemente R, Lescano C, et al. A multisite HIV prevention trial for youth in mental health treatment. Poster presented at the International AIDS Society Conference; 2012 July 22-27; Washington, DC.
Bernstein D, Fink L. Manual for the Childhood Trauma Questionnaire: A retrospective selfreport. San Antonio, TX: The Psychological Corporation; 1998.
Derogatis L, Spencer M. The Brief Symptom Inventory (BSI): Administration, scoring, and procedures manual-1. Baltimore, MD: Johns Hopkins University School of Medicine, Clinical Psychometrics Research Unit; 1982.
Miles M, Huberman A. Qualitative Data Analysis. Thousand Oaks, CA: Sage Publications; 1994.
Liang L, Zeger S. Longitudinal data analysis using generalized linear models. Biometrika. 1986; 73:13-22.
Raudenbush S, et al. Optimal Design Software for Multi-level and Longitudinal Research (Version 3.01) [Software]. www.wtgrantfoundation.org, 2011.
Anthony K, Nagel DM, Goss S. The Use of Technology in Mental Health: Applications ethics and practice. Sringfield, IL: Charles Thomas; 2010.
Luxton DD, McCann RA, Bush NE, Mishkind MC, Reger GM. mHealth for mental health: Integrating smartphone technology in behavioral healthcare. Professional Psychology: Research and Practice. 2011; 42(6):505-512.
Boschen M. Mobile Telephones and Psychotherapy: I: Capability and Applicability. The Behavior Therapist. 2009; 32(8):168-175.
Boschen, M. Mobile Telephones and Psychotherapy: II: A Review of the Empirical Research. The Behavior Therapist. 2009; 32(8):175-182.
CDC. HIV Prevention: Progress to date. 2013. Accessed from:https://www.cdc.gov/nchhstp/newsroom/docs/factsheets/progress-508.pdf

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Responsible Party: Dr. Larry K. Brown, Director of Research, Rhode Island Hospital
ClinicalTrials.gov Identifier: NCT02921841     History of Changes
Other Study ID Numbers: R44MH102140 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Keywords provided by Dr. Larry K. Brown, Rhode Island Hospital:
Adolescents
HIV prevention
computerized intervention
mental health treatment
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases