Digital Star: HIV Prevention for Youth in Mental Health Treatment
Condition: Human Immunodeficiency Virus; Mental Health
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

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).
    

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.
    

Intervention name(s): D*STAR; D*HEALTH
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescents; HIV prevention; computerized intervention; mental health treatment