Clinical trial NCT04850274: 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
Overall status: RECRUITING
Phase: NA
Conditions: Violence
Substance Use
Criminal Behavior
Violence in Adolescence
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-04-20
Enrollment: 750
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in Aggression
timeFrame: Baseline, 6-months, 12-months
measure: Change in Victimization
timeFrame: Baseline, 6-months, 12-months
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Philadelphia
country: United States
facility: HUP and PPMC
state: Pennsylvania
Study officials:
References: