Ignite Creation Date:
2024-05-06 @ 9:11 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02921841
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2016-09-29
Brief Title:
Digital Star HIV Prevention for Youth in Mental Health Treatment
Sponsor:
Rhode Island Hospital
Organization:
Rhode Island Hospital
Study Overview
Official Title:
Digital Star HIV Prevention for Youth in Mental Health Treatment
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DSTAR
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 DSTAR 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 DSTAR 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 DSTAR 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 DSTAR 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
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 DSTAR 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 DSTAR 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 DSTAR 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 DSTAR 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 sessions prototypes and revise based on feedback
D To conduct an open trial of DSTAR 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 DSTAR 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 DSTAR 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 DSTAR compared to the time matched digital HP intervention among 120 adolescents ages 13 to 18 in mental health treatment
Hypothesis Participants in DSTAR 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
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 DSTAR 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 sessions prototypes and revise based on feedback
D To conduct an open trial of DSTAR 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 DSTAR 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 DSTAR 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 DSTAR compared to the time matched digital HP intervention among 120 adolescents ages 13 to 18 in mental health treatment
Hypothesis Participants in DSTAR 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None