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Completed

NCT Number: NCT04850274

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.

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Key information

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grady Health System, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Remote Therapy Intervention (RTI)

Behavioral

A single ED session followed by 5 remote therapy sessions

Artificial Intelligence Remote Therapy Intervention

Behavioral

Optimized by reinforcement learning to step up or down the intensity of treatment between three levels based on patient response to daily assessments.

Primary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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