NCT04850274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
584

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 24, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

May 19, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2026

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

4.7 years

First QC Date

March 24, 2021

Last Update Submit

May 1, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (3)

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

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.

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.

Interventions

A single ED session followed by 5 remote therapy sessions

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.

Artificial Intelligence Remote Therapy Intervention

Eligibility Criteria

Age14 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

HUP and PPMC

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Substance-Related DisordersCriminal Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Emergency Medicine

Study Record Dates

First Submitted

March 24, 2021

First Posted

April 20, 2021

Study Start

May 19, 2021

Primary Completion

February 13, 2026

Study Completion

February 13, 2026

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations