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

January 15, 2020 updated by: Dr. Larry K. Brown, Rhode Island Hospital

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months post-intervention
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 months post-intervention
Lifetime Sexual Intercourse
Time Frame: 3-months post-intervention
Lifetime oral, vaginal, and/or anal sex
3-months post-intervention
Recent Oral, Vaginal, and/or Anal Sex
Time Frame: 3-months post-intervention
Oral, vaginal, and/or anal sex in the past 3 months
3-months post-intervention
Frequency of Sexual Intercourse
Time Frame: 3-months post-intervention
Number of oral, vaginal, and/or anal sexual occurrences in the past 3 months.
3-months post-intervention
Number of Sexual Partners
Time Frame: 3-months post-intervention
Number of sexual partners in the past 3 months.
3-months post-intervention
Frequency of Condom Use
Time Frame: 3-months post-intervention
Number of times a condom was used during oral, vaginal, and/or anal sex
3-months post-intervention
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.".
3-months post-intervention
Recent Alcohol Use
Time Frame: 3-months post-intervention
Alcohol use in the past 30 days (yes/no)
3-months post-intervention
Frequency of Recent Alcohol Use
Time Frame: 3-months post-intervention
Number of days alcohol was used in the past 30 days
3-months post-intervention
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
3-months post-intervention
Recent Marijuana Use
Time Frame: 3-months post-intervention
Marijuana use in the past 30 days (yes/no)
3-months post-intervention
Frequency of Recent Marijuana Use
Time Frame: 3-months post-intervention
Number of days marijuana was used in the past 30 days
3-months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months post-intervention (average 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Collaborators

Virtually Better, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

September 29, 2016

First Submitted That Met QC Criteria

September 30, 2016

First Posted (Estimate)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 15, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R44MH102140 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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