Using Re-inforcement Learning to Automatically Adapt a Remote Therapy Intervention (RTI) for Reducing Adolescent Violence Involvement

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use; Violence in Adolescence; Violence; Criminal Behavior
• Intervention / Treatment: Behavioral: Remote Therapy Intervention (RTI); Behavioral: Artificial Intelligence Remote Therapy Intervention

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 Type: Interventional
• Enrollment (Estimated): 750
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick M Carter, M.D.; Phone Number: 734-615-8706; Email: cartpatr@med.umich.edu
• Study Contact Backup: Name: Lynn S Massey, MSW; Phone Number: 734-615-8706; Email: lsmassey@med.umich.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Recruiting
      • Grady Health System
      • Contact: Patrick Carter; Phone Number: 734-647-6125; Email: cartpatr@med.umich.edu
  • Michigan
    • Detroit, Michigan, United States, 48236
      • Recruiting
      • Ascension St. John Hospital
      • Contact: Patrick Carter; Phone Number: 734-647-6125; Email: cartpatr@med.umich.edu
    • Flint, Michigan, United States, 48503
      • Recruiting
      • Hurley Medical Center
      • Contact: Patrick Carter; Phone Number: 734-647-6125; Email: cartpatr@med.umich.edu
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • HUP and PPMC
      • Contact: Patrick Carter; Phone Number: 734-647-6125; Email: cartpatr@med.umich.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 24 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote Therapy Intervention; Youth will receive the maximal dose of six S-RTI therapy sessions delivered by a remote therapist with no alteration in intensity	Behavioral: Remote Therapy Intervention (RTI); A single ED session followed by 5 remote therapy sessions
Experimental: Artificial Intelligence Remote Therapy 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.	Behavioral: Artificial Intelligence Remote Therapy Intervention; Optimized by reinforcement learning to step up or down the intensity of treatment between three levels based on patient response to daily assessments.
No Intervention: Enhanced Usual Care; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	Baseline, 6-months, 12-months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 24, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 16, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: HUM00160149; 5R01HD097107-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No