Technology-based Training Tool for PHAT Life

NCT ID: NCT05339412

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-26
• Study Completion Date: 2024-12-20

Brief Summary

Youth under age 18 involved in the criminal justice system are disproportionately minorities & affected by substance abuse, mental illness, & HIV/STI. Most young offenders are released on community supervision without the STI, mental health, or substance use screening, diagnosis, & treatment afforded detained youth, despite similar rates of risk behavior. Their long-term trajectory is poor, costs to society are high, & lasting effects on community well-being & individual employment prospects are profound. Altering this trajectory is a public health priority. Preventing HIV Among Teens (PHAT) Life is an evidence-based program that meets the need in juvenile justice to address youths' co-morbid health problems. The next step in ensuring that this decade-long line of research produces actual, real-world improvements in the lives of probation youth is to develop a PHAT Life training strategy that is effective, cost-effective, & sustainable within juvenile justice settings. The private/public collaboration between ORBIS & UIC will leverage existing resources & competencies to create a commercially viable technology-based training tool for PHAT Life with great potential for sustainability & cost-effectiveness. This Phase II uses a formative process to refine, enhance & complete the technology-based training tool to include: (a) an interactive multimedia web browser & mobile application, (b) dynamic multimedia presentations & interactive queries, (c) video examples of mock intervention delivery, (d) audio narration along with scripted language, (e) brief quizzes to ensure comprehension & knowledge acquisition, (f) opportunities to "learn more" by clicking on tabs for supplemental information, (g) targeted referrals to appendix materials, (h) games to promote engagement, & (i) other adaptations based on Phase I feedback. The proposed technology-based training tool should be highly sustainable, because it (a) relies on "indigenous" personnel to deliver the intervention, (b) is likely to prove cost-effective since it will utilize a technology that can deliver training at scale, & (c) will improve fidelity by leveraging technology to provide consistent training experiences to para-professionals. The training tool will be evaluated via a 2-arm RCT with 130 individuals who work with justice-involved youth. Trainees will receive the technology-based training tool.

Detailed Description

This study will comply with the NIH Policy on the Use of sIRB for Multi-Site Research. The University of Illinois Chicago (UIC) has been selected to serve as the single IRB of record (sIRB) for the research described in this proposal. Once the PHAT Life Training Tool is complete, Investigators will enroll 6 paraprofessionals to conduct a brief usability test to ensure the tool is working properly. After edits are made based on the feedback from the usability test, 10 paraprofessionals who work with justice-involved youth will pilot test the study materials and protocol to ensure that Investigators are ready for scale in a randomized trial. To meet the proposed study's aims, the research team has commitment from three sites who serve justice-involved youth (see Letters of Support): (a) Cook County Juvenile Temporary Detention Center, (b) Cook County Department of Probation and Court Services, and (c) Heartland Alliance. Together, there are about 445 eligible staff across settings. The proposed sample (N=130) represents 29% of eligible participants. Investigators, thus, expect minimal difficulty reaching the proposed sample size. Researchers will present the project at agency staff meetings and invite people to indicate interest. Flyers will be posted in relevant spaces with researcher contact information. Researchers will offer to present information about the project at agency events. Agency staff will distribute recruitment materials to eligible personnel (e.g., probation staff or public health educators) and invite them to contact the researchers. The agency staff will also invite individuals to consent to release their contact information for the research team to contact them directly. The recruitment coordinator will contact interested individuals by phone, email, text, and instant messenger. Recruitment will continue in this manner until enrollment goals are met for each condition.

Once enrolled in the study, participants will be assigned a unique, de-identifiable project ID number, which will be affiliated with their baseline survey, Training Tool, and post-training survey. Research staff will fully explain the study and ask for their consent to participate. Participants will indicate their consent via project webpage just prior to the baseline assessment. Participants will be randomized to condition after completing their baseline measures via Qualtrics. A table will be created based on a computer-generated random numbers list that will be used by research staff to assign condition. Participants will then be provided with their login information and instructions for accessing the PHAT Life Training Tool. For those in the Training Tool Plus Supervision condition, participants will receive individualized supervision and participate in two mock role-plays of PHAT Life activities after completing the training tool. All participants will be sent the post-training assessments via Qualtrics. Finally, participants will be instructed to lead one PHAT Life group where they will audio record sessions 1 and 4 of the PHAT Life curriculum.

Conditions

HIV Infection; Sexually Transmitted Infections; Implementation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Technology Based Training Tool Only

The technology-based training tool will train facilitators to deliver the behavioral health intervention PHAT Life, which is an innovative HIV/STI, substance use, and mental health intervention for juvenile offenders. The training tool reviews each of PHAT Life's 8 sessions. The curriculum targets broad psychosocial factors implicated in HIV/STI-risk behavior, including promoting positive attitudes toward HIV/STI prevention, self-efficacy to reduce risk, and less substance misuse and sexual risk taking. Content emphasizes the importance of emotion regulation skills to manage strong feelings, uses goal setting and training in positive thought processes to plan ahead, encourages recognition of personal responsibility in future outcomes, and helps youth identify strategies and behaviors to accomplish short- and long-term goals.

Group Type: EXPERIMENTAL

Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life

Intervention Type: BEHAVIORAL

The technology-based training tool will train facilitators to deliver the behavioral health intervention PHAT Life, which is an innovative HIV/STI, substance use, and mental health intervention for juvenile offenders. The training tool reviews each of PHAT Life's 8 sessions. The curriculum targets broad psychosocial factors implicated in HIV/STI-risk behavior, including promoting positive attitudes toward HIV/STI prevention, self-efficacy to reduce risk, and less substance misuse and sexual risk taking. Content emphasizes the importance of emotion regulation skills to manage strong feelings, uses goal setting and training in positive thought processes to plan ahead, encourages recognition of personal responsibility in future outcomes, and helps youth identify strategies and behaviors to accomplish short- and long-term goals.

Technology Based Training Tool plus Live Supervision

Participants randomized to this condition will receive (in addition to the training tool described above) access to live supervision delivered remotely via commercially available video conferencing software (Zoom). Facilitators-in-training will complete two mock roleplays of curriculum activities, which can be conducted live via Zoom with PHAT Life trainers (either Dr. Floyd or Dr. Snow-Hill) or can be recorded and submitted via the app. Trainers will review for fidelity and provide feedback. During the supervision sessions, participants will have the opportunity to clarify content, ask questions, roleplay group sessions to practice difficult parts of the group sessions, and review feedback on role plays.

Group Type: EXPERIMENTAL

Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life

Intervention Type: BEHAVIORAL

The technology-based training tool will train facilitators to deliver the behavioral health intervention PHAT Life, which is an innovative HIV/STI, substance use, and mental health intervention for juvenile offenders. The training tool reviews each of PHAT Life's 8 sessions. The curriculum targets broad psychosocial factors implicated in HIV/STI-risk behavior, including promoting positive attitudes toward HIV/STI prevention, self-efficacy to reduce risk, and less substance misuse and sexual risk taking. Content emphasizes the importance of emotion regulation skills to manage strong feelings, uses goal setting and training in positive thought processes to plan ahead, encourages recognition of personal responsibility in future outcomes, and helps youth identify strategies and behaviors to accomplish short- and long-term goals.

Interventions

Training Tool for Preventing HIV/AIDS among Teens (PHAT) Life

The technology-based training tool will train facilitators to deliver the behavioral health intervention PHAT Life, which is an innovative HIV/STI, substance use, and mental health intervention for juvenile offenders. The training tool reviews each of PHAT Life's 8 sessions. The curriculum targets broad psychosocial factors implicated in HIV/STI-risk behavior, including promoting positive attitudes toward HIV/STI prevention, self-efficacy to reduce risk, and less substance misuse and sexual risk taking. Content emphasizes the importance of emotion regulation skills to manage strong feelings, uses goal setting and training in positive thought processes to plan ahead, encourages recognition of personal responsibility in future outcomes, and helps youth identify strategies and behaviors to accomplish short- and long-term goals.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Any staff at the recruitment sites who provides services to justice-involved youth will be eligible for this study
• Given that the training and curriculum are only offered in English, English-speaking will be an inclusion criterion

Exclusion Criteria

• Unable to speak English

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: collaborator

Oregon Research Behavioral Intervention Strategies, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Behavioral Intervention Strategies, Inc.

Locations

Oregon Research Behavioral Intervention Strategies, Inc.

Springfield, Oregon, United States

Countries

United States

Other Identifiers

MD014113-02

Identifier Type: -

Identifier Source: org_study_id