AI-Enhanced Remote Therapy for Adolescent Violence

Not currently recruiting at 3 trial locations

Overseen By Lynn S Massey, MSW

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Non-English speakers, Mental incompetence, Incarceration, Medical instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce violence involvement among young people who have visited the Emergency Department (ED) for violent injuries. It will test two versions of remote therapy: a standard remote therapy intervention (S-RTI) and an AI-enhanced version (AI-RTI, Artificial Intelligence Remote Therapy Intervention), which uses artificial intelligence to tailor therapy sessions. The trial seeks to identify the best methods for delivering these interventions, particularly for young people from lower-income backgrounds. Young individuals treated in the ED for violent injuries who own a smartphone with texting and internet access might be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches that could significantly impact young people's lives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that remote therapy methods, like those in this study, have generally been well-received in past trials. These methods have reduced violence and aggression among participants. Although specific safety data for the Artificial Intelligence Remote Therapy Intervention (AI-RTI) is limited, similar AI therapy programs have not reported major negative effects.

For the Remote Therapy Intervention (RTI), studies have demonstrated a reduction in violence-related issues without major side effects. Participants have been monitored over time, and these methods are generally considered safe.

While no specific safety concerns have been reported for these therapies, the trial remains in the early stages of testing for this purpose. However, the techniques used have been applied safely in other situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they integrate artificial intelligence (AI) with remote therapy to manage adolescent violence, a novel approach compared to traditional in-person therapy or self-help resources. The AI-enhanced remote therapy uses a reinforcement learning system to tailor the intensity of therapy sessions, offering personalized interventions like video chats or electronic Motivational Interviewing. This dynamic, tech-driven method could provide more accessible, flexible, and individualized care, potentially improving outcomes for youths who might not otherwise engage with conventional therapy options.

What evidence suggests that this trial's treatments could be effective for reducing adolescent violence?

Research has shown that the Remote Therapy Intervention (RTI), one of the treatments in this trial, yields promising results in reducing violence among teenagers. In one study, violent behaviors significantly decreased from 90% to 20%, marking a substantial improvement. Another study found that RTI helped reduce aggression, victimization, and negative effects related to violence and alcohol use.

In this trial, some participants will receive the AI-Enhanced Remote Therapy Intervention. Early results suggest that this version can automatically adjust therapy sessions using artificial intelligence, making treatments more effective and personalized. The AI system determines the intensity of each session based on individual needs, aiming to enhance the therapy's effectiveness. This new approach seeks to reduce involvement in violence by tailoring the therapy to each teenager's unique situation. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for young people aged 14-24 who have been treated in the emergency department for a violent injury and own a smartphone. They must understand English and be able to consent. Those with mental incompetence, without a guardian if under 18, or involved in certain crimes like sexual assault are excluded.

Inclusion Criteria

I am aged 14-24, was injured in violence, own a smartphone with text and internet.

Exclusion Criteria

Youth will be excluded if they do not understand English, cannot provide informed consent due to mental incompetence, incarceration or medical instability (unstable patients will be recruited if they stabilize within 72 hours), are 14-17 years old and presenting without an accessible parent/guardian, are presenting for suicide attempt/intent, sexual assault, and/or child abuse (due to high intensity of social services needed for such patients during their ED visit).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Remote Therapy Session

Youth receive an initial remote therapy session in the Emergency Department

1 session

1 visit (in-person)

Adaptive Remote Therapy

The RL system determines the intensity of subsequent therapy sessions over 11 weeks

11 weeks

Bi-weekly sessions (remote)

Follow-up

Participants are monitored for changes in victimization and aggression at 6 and 12 months

12 months

Assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Artificial Intelligence Remote Therapy Intervention
• Remote Therapy Intervention (RTI)

Trial Overview The study compares two remote therapy interventions aimed at reducing violence among adolescents: one standard version (S-RTI) and another enhanced by Artificial Intelligence (AI-RTI). It's set up as a randomized control trial where participants are randomly assigned to either intervention.

How Is the Trial Designed?

Group I: Remote Therapy Intervention Experimental Treatment 1 Intervention

Youth will receive the maximal dose of six S-RTI therapy sessions delivered by a remote therapist with no alteration in intensity

Group II: Artificial Intelligence Remote Therapy Intervention Experimental Treatment 1 Intervention

Youth will first receive a remote therapy session in the Emergency Department (ED). The RL system will then make decisions about the intensity of each subsequent therapy session (the initial decision is seven days post ED visit and bi-weekly \[i.e., every other two weeks\] thereafter) for the next 11 weeks. Potential treatment decisions include a 30-minute remote therapy session delivered via phone or video chat (mirroring the S-RTI), a less intensive tailored Motivational Interviewing (MI)-adherent electronic remote therapy (delivered by an electronic robot), or an assessment only without intervention.

Group III: Enhanced Usual Care Active Control 1 Intervention

The youth's retaliatory risk will be assessed and a pamphlet with referrals for violence, substance use, and mental health services will be provided.

Artificial Intelligence Remote Therapy Intervention is already approved in United States for the following indications:

Approved in United States as AI-RTI for:

• Reducing adolescent violence involvement
• Negative behaviors and consequences associated with violent injuries

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A systematic review of 10 studies found that using artificial intelligence (AI), particularly conversational AI agents like chatbots, can significantly enhance psychotherapy outcomes and reduce symptoms in patients with emotional disorders.

Patients reported high satisfaction and engagement when AI was integrated into therapy, suggesting that AI can make psychological interventions more personalized and effective, although further robust research is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Artificial Intelligence to Enhance Ongoing Psychological Interventions for Emotional Problems in Real- or Close to Real-Time: A Systematic Review. Gual-Montolio, P., Jaén, I., Martínez-Borba, V., et al.[2022]

Remote access therapy has shown significant benefits for veterans, including improved accessibility, flexibility in scheduling, and ease of use of technology, as evidenced by a review of 15 studies from the US and UK.

Despite some limitations, such as concerns about acceptability and the need for better infrastructure, the overall outcomes for veterans using remote therapy were positive, indicating that this method can be effective for delivering psychological support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Access Therapy for Veterans With Psychological Problems: Current State of the Art. Fleuty, K., Almond, MK.[2021]

The behavioral coaching chatbot Tess was successfully integrated into the counseling of 23 adolescent patients dealing with weight management and prediabetes, showing high engagement with 4,123 messages exchanged and 96% of users finding it helpful.

Adolescents reported positive progress toward their health goals 81% of the time, indicating that Tess effectively supported treatment adherence and behavior change, demonstrating the potential for BITs to enhance behavioral health interventions in pediatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of pediatric obesity and prediabetes treatment support through Tess, the AI behavioral coaching chatbot. Stephens, TN., Joerin, A., Rauws, M., et al.[2020]

In a study involving 40 racially and ethnically diverse children aged 3-5 with disruptive behavior disorders, Internet-delivered parent-child interaction therapy (I-PCIT) showed a higher treatment response rate (70%) compared to standard clinic-based PCIT (55%) after treatment.

I-PCIT not only resulted in significant improvements in children's symptoms and reduced parental burden but also had fewer perceived barriers to treatment, indicating it may be a more accessible option for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remotely delivering real-time parent training to the home: An initial randomized trial of Internet-delivered parent-child interaction therapy (I-PCIT). Comer, JS., Furr, JM., Miguel, EM., et al.[2022]

The Robot-mediated Imitation Skill Training Architecture (RISTA) shows promise in teaching imitation skills to children with autism spectrum disorder (ASD), as it captures their attention more effectively than traditional human therapists.

Preliminary user studies indicate that RISTA may enhance gesture learning in children with ASD, suggesting that robotic interventions could be a valuable tool in therapy, although further research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-Mediated Imitation Skill Training for Children With Autism. Zheng, Z., Young, EM., Swanson, AR., et al.[2023]

Remote psychotherapies for youth have been found to be effective, with a pooled effect size of 0.47 at post-treatment, comparable to in-person therapy, based on a review of 37 randomized controlled trials involving various mental health issues.

The effectiveness of remote therapy is enhanced when there is direct contact with a therapist, particularly for anxiety and conduct problems, and when skill-building activities are included, indicating that the type of support and engagement significantly influences treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of youth psychotherapy delivered remotely: A meta-analysis. Venturo-Conerly, KE., Fitzpatrick, OM., Horn, RL., et al.[2022]

A systematic review of 30 studies involving 1462 participants found that robot-assisted psychological interventions generally foster positive therapeutic engagement, particularly among older adults with dementia and children with autism.

Despite the promising results, the studies had methodological limitations, including small sample sizes and a lack of control groups, indicating that more rigorous research is needed to fully understand the effectiveness and implications of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic engagement in robot-assisted psychological interventions: A systematic review. Riches, S., Azevedo, L., Vora, A., et al.[2022]

The use of artificial intelligence (AI) in psychiatry has increased significantly, especially during the COVID-19 pandemic, to address the shortage of mental health providers and improve access to mental health care.

AI applications, such as chatbots and therapy bots, are being developed to assist with psychiatric diagnoses, symptom tracking, and emotional coping mechanisms, showing promise in enhancing mental health support and treatment delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artificial Intelligence and Chatbots in Psychiatry. Pham, KT., Nabizadeh, A., Selek, S.[2022]

This study will evaluate the effectiveness of an innovative internet-based cognitive behavioral therapy (iCBT) program enhanced by artificial intelligence (AI) technologies to improve depression among 1400 healthy workers during the COVID-19 pandemic.

The program, called SMART-CBT, consists of a 6-week course with machine-guided exercises and aims to provide a cost-effective mental health solution that can be widely disseminated, marking the first randomized controlled trial of its kind.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Internet-Based Machine-Guided Stress Management Program Based on Cognitive Behavioral Therapy for Improving Depression Among Workers: Protocol for a Randomized Controlled Trial. Kawakami, N., Imamura, K., Watanabe, K., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04850274

Study Details | NCT04850274 | Using Re-inforcement ... The study examines two versions of the remote therapy intervention - a standard RTI (S-RTI) and an Artificial Intelligence RTI (AI-RTI). The application of a ...

2. reporter.nih.gov reporter.nih.gov/project-details/9915957

Clinical Studies - NIH RePORTER Using Re-inforcement Learning to Automatically Adapt a Remote Therapy Intervention (RTI) for Reducing Adolescent Violence Involvement. Project Number ...

3. withpower.com withpower.com/trial/phase-substance-related-disorders-4-2021-2ac35

AI-Enhanced Remote Therapy for Adolescent Violence This study will evaluate the effectiveness of an innovative internet-based cognitive behavioral therapy (iCBT) program enhanced by artificial intelligence (AI) ...

4. clinicaltrial.be clinicaltrial.be/en/details/44985?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Using Re-inforcement Learning to Automatically Adapt a Re... Aggression will be measured at baseline, 6-month follow-up, 12-month follow-up. Conflict Tactic Scale measures have been used in prior work and ...

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04850274?keyword=%22Criminal%20Behavior%22

San Mateo Clinical Trial Using Re-inforcement Learning to ... Using Re-inforcement Learning to Automatically Adapt a Remote Therapy Intervention (RTI) for Reducing Adolescent Violence Involvement. Share: Global Content ...