ViolenceNCT04850274
Using Re-inforcement Learning to Automatically Adapt a Remote Therapy Intervention (RTI) for Reducing Adolescent Violence Involvement
A study testing Remote Therapy Intervention (RTI) and Artificial Intelligence Remote Therapy Intervention in people with Violence and Substance Use, run by University of Michigan at 4 sites in United States.
Trial summary
This study will use a randomized control trial (RCT) design to administer two versions of a multisession remote behavioral intervention for youth seeking Emergency Department care for a violent injury with the goal to reduce their violence involvement and associated negative behaviors and consequences. Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Violence, Substance Use, Criminal Behavior
- What is being tested?
- Remote Therapy Intervention (RTI) and Artificial Intelligence Remote Therapy Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 May 2021to 13 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Youth will be eligible if they screen is positive for seeking treatment in the ED for a violent injury, age 14-24, and report ownership of a smartphone with texting capability and internet access.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Grady Health System
Atlanta, Georgia, 30303
Ascension St. John Hospital
Detroit, Michigan, 48236
Hurley Medical Center
Flint, Michigan, 48503
HUP and PPMC
Philadelphia, Pennsylvania, 19104
About this study
This study will use a randomized control trial (RCT) design to administer two versions of a multisession remote behavioral intervention for youth seeking Emergency Department care for a violent injury with the goal to reduce their violence involvement and associated negative behaviors and consequences. 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 just-in-time adaptive strategy to address youth violence is an important and novel direction for this research, particularly given the need to understand best practices for delivering behavioral interventions among lower-income populations.
Read the detailed description
The Specific Aims for the proposed study are to refine the Remote Therapy Intervention (RTI) for delivery using a standardized remote therapy package (S-RTI; 1 ED + 5 remote sessions) based on a piloted RTI and an adaptive RTI that optimizes bi-weekly dose and intervention intensity between four levels of therapy (remote therapy+, remote therapy; automated electronic tailored therapy; none) based on a reinforcement learning (RL) algorithm [AI-RTI]. A total of 750 youth (age=14-24) seeking ED care for a violent injury will be enrolled and randomly assigned (stratified by age/gender) to the S-RTI (n=250), AI-RTI (n=300), and a control (EUC; n=200) condition. In addition to the randomized assignment, all youth will take a daily assessment over the course of the intervention timeline. Outcomes will be assessed at 6 and 12 months.
- Conditions
- Violence, Substance Use, Criminal Behavior, Violence in Adolescence
- Being tested
- Remote Therapy Intervention (RTI), Artificial Intelligence Remote Therapy Intervention
- Medical subject headings
- Substance-Related Disorders, Criminal Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Therapy Intervention (RTI)Behavioural
A single ED session followed by 5 remote therapy sessions
Artificial Intelligence Remote Therapy InterventionBehavioural
Optimized by reinforcement learning to step up or down the intensity of treatment between three levels based on patient response to daily assessments.
| Study group | Role | What they receive |
|---|---|---|
| Remote Therapy Intervention | Experimental | Youth will receive the maximal dose of six S-RTI therapy sessions delivered by a remote therapist with no alteration in intensity Receives: Behavioral: Remote Therapy Intervention (RTI) |
| Artificial Intelligence Remote Therapy Intervention | Experimental | 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. Receives: Behavioral: Artificial Intelligence Remote Therapy Intervention |
| Enhanced Usual Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Aggression
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 is scored using a summary score (0=Never; 6=20+ Times).
Measured: Baseline, 6-months, 12-months
Change in Victimization
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 is scored using a summary score (0=Never; 6=20+ Times).
Measured: Baseline, 6-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start19 May 2021
- Primary completion13 Feb 2026
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 584 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Patrick Carter, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850274
- Sponsor's protocol ID
- HUM00160149
- Other IDs
- 5R01HD097107-03
- Status last verified
- May 2026
- First submitted
- 24 Mar 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Re-inforcement Learning to Automatically Adapt a Remote Therapy Intervention (RTI) for Reducing Adolescent Violence Involvement
- ClinicalTrials.gov ID
- NCT04850274
- Acronym / sponsor ID
- HUM00160149
- Conditions
- Violence, Substance Use, Criminal Behavior, Violence in Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 584 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 19 May 2021 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use a randomized control trial (RCT) design to administer two versions of a multisession remote behavioral intervention for youth seeking Emergency Department care for a violent injury with the goal to reduce their violence involvement and associated negative behaviors and consequences. 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 just-in-time adaptive strategy to address youth violence is an important and novel direction for this research, particularly given the need to understand best practices for delivering behavioral interventions among lower-income populations.
Detailed description
The Specific Aims for the proposed study are to refine the Remote Therapy Intervention (RTI) for delivery using a standardized remote therapy package (S-RTI; 1 ED + 5 remote sessions) based on a piloted RTI and an adaptive RTI that optimizes bi-weekly dose and intervention intensity between four levels of therapy (remote therapy+, remote therapy; automated electronic tailored therapy; none) based on a reinforcement learning (RL) algorithm [AI-RTI]. A total of 750 youth (age=14-24) seeking ED care for a violent injury will be enrolled and randomly assigned (stratified by age/gender) to the S-RTI (n=250), AI-RTI (n=300), and a control (EUC; n=200) condition. In addition to the randomized assignment, all youth will take a daily assessment over the course of the intervention timeline. Outcomes will be assessed at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Remote Therapy Intervention | Experimental | Behavioral: Remote Therapy Intervention (RTI)Youth will receive the maximal dose of six S-RTI therapy sessions delivered by a remote therapist with no alteration in intensity |
| Artificial Intelligence Remote Therapy Intervention | Experimental | Behavioral: Artificial Intelligence Remote Therapy InterventionYouth 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. |
| Enhanced Usual Care | No 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. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Youth will be eligible if they screen is positive for seeking treatment in the ED for a violent injury, age 14-24, and report ownership of a smartphone with texting capability and internet access.
Key exclusion criteria (1 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Therapy Intervention (RTI)A single ED session followed by 5 remote therapy sessions | Behavioural | Remote Therapy Intervention |
| Artificial Intelligence Remote Therapy InterventionOptimized by reinforcement learning to step up or down the intensity of treatment between three levels based on patient response to daily assessments. | Behavioural | Artificial Intelligence Remote Therapy Intervention |
Primary outcome
Change in Aggression
Time frame: Baseline, 6-months, 12-months
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 is scored using a summary score (0=Never; 6=20+ Times).
Change in Victimization
Time frame: Baseline, 6-months, 12-months
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 is scored using a summary score (0=Never; 6=20+ Times).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
Related trials for Violence
Not yet recruiting
Group Cognitive Processing Therapy for Women Survivors of Gender-Based Violence: Feasibility Study
Trauma, Psychological, Traumatic Stress Disorder
Active, not recruiting
Recovery Legal Care Pilot
Firearm Injury, Economic Problems
Recruiting
Virtual Reality Intervention (VR-GINSO) for Reducing Aggression in Young Offenders
Aggression
Recruiting
Adjunctive Motivational Alcohol Intervention to Prevent IPV
Alcohol Use and Intimate Partner Violence
Active, not recruiting
YES: Innovative Discussion for Engagement, Achievement, and Service
Violence Prevention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Therapy Intervention (RTI) and Artificial Intelligence Remote Therapy Intervention in people with Violence and Substance Use, run by University of Michigan at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Aggression (time frame: Baseline, 6-months, 12-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.