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

Primary Purpose

Violence, Substance Use, Criminal Behavior

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Therapy Intervention (RTI)
Artificial Intelligence Remote Therapy Intervention
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Violence

Eligibility Criteria

14 Years - 24 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Youth will be eligible if they screen is positive for seeking treatment in the ED for a violent injury, age 14-20, 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).

Sites / Locations

  • Grady Health System
  • Ascension St. John HospitalRecruiting
  • Hurley Medical CenterRecruiting
  • HUP and PPMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Remote Therapy Intervention

Artificial Intelligence Remote Therapy Intervention

Enhanced Usual Care

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Full Information

First Posted
March 24, 2021
Last Updated
March 4, 2023
Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT04850274
Brief Title
Using Re-inforcement Learning to Automatically Adapt a Remote Therapy Intervention (RTI) for Reducing Adolescent Violence Involvement
Official Title
Using Re-inforcement Learning to Automatically Adapt a Remote Therapy Intervention (RTI) for Reducing Adolescent Violence Involvement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 19, 2021 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Violence, Substance Use, Criminal Behavior, Violence in Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
750 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote Therapy Intervention
Arm Type
Experimental
Arm Description
Youth will receive the maximal dose of six S-RTI therapy sessions delivered by a remote therapist with no alteration in intensity
Arm Title
Artificial Intelligence Remote Therapy Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
No Intervention
Arm Description
The youth's retaliatory risk will be assessed and a pamphlet with referrals for violence, substance use, and mental health services will be provided.
Intervention Type
Behavioral
Intervention Name(s)
Remote Therapy Intervention (RTI)
Intervention Description
A single ED session followed by 5 remote therapy sessions
Intervention Type
Behavioral
Intervention Name(s)
Artificial Intelligence Remote Therapy Intervention
Intervention Description
Optimized by reinforcement learning to step up or down the intensity of treatment between three levels based on patient response to daily assessments.
Primary Outcome Measure Information:
Title
Change in Aggression
Description
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).
Time Frame
Baseline, 6-months, 12-months
Title
Change in Victimization
Description
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).
Time Frame
Baseline, 6-months, 12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick M Carter, M.D.
Phone
734-615-8706
Email
cartpatr@med.umich.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lynn S Massey, MSW
Phone
734-615-8706
Email
lsmassey@med.umich.edu
Facility Information:
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Carter
Phone
734-647-6125
Email
cartpatr@med.umich.edu
Facility Name
Ascension St. John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Carter
Phone
734-647-6125
Email
cartpatr@med.umich.edu
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Carter
Phone
734-647-6125
Email
cartpatr@med.umich.edu
Facility Name
HUP and PPMC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Carter
Phone
734-647-6125
Email
cartpatr@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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