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

• ClinicalTrials.gov Identifier: NCT02921841
• Recruitment Status: Completed
• First Posted: October 3, 2016
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Sponsor: Rhode Island Hospital
• Collaborator: Virtually Better, Inc.
• Information provided by (Responsible Party): Dr. Larry K. Brown, Rhode Island Hospital

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. HIV Knowledge [ Time Frame: 3 months post-intervention ]
   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.
2. Self-efficacy for HIV Prevention [ Time Frame: 3 months post-intervention ]
   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. Lifetime Sexual Intercourse [ Time Frame: 3-months post-intervention ]
   Lifetime oral, vaginal, and/or anal sex
4. Recent Oral, Vaginal, and/or Anal Sex [ Time Frame: 3-months post-intervention ]
   Oral, vaginal, and/or anal sex in the past 3 months
5. Frequency of Sexual Intercourse [ Time Frame: 3-months post-intervention ]
   Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months.
6. Number of Sexual Partners [ Time Frame: 3-months post-intervention ]
   Number of sexual partners in the past 3 months.
7. Frequency of Condom Use [ Time Frame: 3-months post-intervention ]
   Number of times a condom was used during oral, vaginal, and/or anal sex
8. Condom Use Intention [ Time Frame: 3-months post-intervention ]
   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.".
9. Recent Alcohol Use [ Time Frame: 3-months post-intervention ]
   Alcohol use in the past 30 days (yes/no)
10. Frequency of Recent Alcohol Use [ Time Frame: 3-months post-intervention ]
    Number of days alcohol was used in the past 30 days
11. Quantity of Recent Alcohol Use [ Time Frame: 3-months post-intervention ]
    Number of drinks reported on days that a participant drank alcohol in the past 30 days
12. Recent Marijuana Use [ Time Frame: 3-months post-intervention ]
    Marijuana use in the past 30 days (yes/no)
13. Frequency of Recent Marijuana Use [ Time Frame: 3-months post-intervention ]
    Number of days marijuana was used in the past 30 days

Secondary Outcome Measures :

1. Affect Dysregulation Scale [ Time Frame: 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.") in sexual situations. Scores range from 6 to 24 with higher scores indicated poorer perceived ability to manage emotional upset in sexual situations.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Rhode Island

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Sponsors and Collaborators

Rhode Island Hospital

Virtually Better, Inc.

Investigators

• Principal Investigator: Margo Adams Larsen, PhD; Virtually Better, Inc.

  Study Documents (Full-Text)

Documents provided by Dr. Larry K. Brown, Rhode Island Hospital:

Study Protocol and Statistical Analysis Plan  [PDF] April 16, 2019

More Information

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• Responsible Party: Dr. Larry K. Brown, Director of Research, Rhode Island Hospital
• ClinicalTrials.gov Identifier: NCT02921841
• Other Study ID Numbers: R44MH102140 ( U.S. NIH Grant/Contract )
• First Posted: October 3, 2016
• Results First Posted: January 27, 2020
• Last Update Posted: January 27, 2020
• Last Verified: January 2020

Keywords provided by Dr. Larry K. Brown, Rhode Island Hospital:

Adolescents; HIV prevention; computerized intervention; mental health treatment

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases