Digital Star: HIV Prevention for Youth in Mental Health Treatment
| Status: | Active, not recruiting |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS, HIV / AIDS, Psychiatric |
| Therapuetic Areas: | Immunology / Infectious Diseases, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 13 - 20 |
| Updated: | 3/21/2019 |
| Start Date: | November 2016 |
| End Date: | July 2019 |
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).
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.
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.
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.
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