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

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850274
• Other study ID #: HUM00160149
• Secondary ID: 5R01HD097107-03
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: March 2025

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: Patrick M Carter, M.D.
• Phone: 734-615-8706
• Email: cartpatr[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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).

Related Conditions & MeSH terms

• Criminal Behavior
• Substance Use
• Substance-Related Disorders
• Violence
• Violence in Adolescence

Intervention

Behavioral:
• Remote Therapy Intervention (RTI)
A single ED session followed by 5 remote therapy sessions
• 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.

Locations

Country	Name	City	State
United States	Grady Health System	Atlanta	Georgia
United States	Ascension St. John Hospital	Detroit	Michigan
United States	Hurley Medical Center	Flint	Michigan
United States	HUP and PPMC	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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