Project IntERact Study

University of Michigan

Status: Completed

Conditions: Substance Use; Criminal Behavior; Violence

Treatments: Behavioral: IntERact

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03940716

K23DA039341 (U.S. NIH Grant/Contract)

HUM00104549

Details and patient eligibility

About

This study will use a randomized control trial design (RCT) to pilot test a multisession remote therapy behavioral intervention for risky firearm behaviors and associated behaviors/consequences among adolescents. The study will pilot a state-of-the-art intervention delivery approaches (e.g., remote therapy, smartphone-based APP intervention content delivery) for reducing violence and associated behaviors among urban youth. Given the significant morality and mortality associated with firearm violence, the study will have significant impact by identifying optimal intervention strategies for future large-scale behavioral intervention trials.

Full description

The specific aim of this pilot study is to pilot test an m-health intervention, as compared to enhanced usual care [n=70; 35/group], with eligible youth to assess intervention acceptability, feasibility, and fidelity, as well as trends towards decreased risky firearm behaviors, substance use, and criminal justice involvement. Specifically, 70 youth (ages 16-24) in the ED screening positive for firearm carriage and smartphone ownership will be randomly assigned (stratified by age/gender) to either the IntERact group or the control group. IntERact group participants will receive an Emergency Department (ED) session of behavioral therapy, followed by five additional remote therapy sessions of behavioral therapy delivered over the 5 weeks following their ED visit. Behavioral therapy will be comprised of motivational interviewing (MI), cognitive behavioral therapy (CBT), and strengths-based care management (CM). In addition, youth in the IntERact group will also receive a smartphone APP that will be downloaded to their phone. The APP will deliver daily surveys, daily tailored MI and CBT messages in response to survey results, one-touch access to pro-social supports, psycho-educational materials, GPS-enabled message alerts, and facilitated access to CM resources. Youth enrolled in the control group will receive a pamphlet with local violence, substance use, and mental health resources. A follow-up assessment will be completed in each group at 4 months post-ED visit. Pilot data will aid in refining and clarifying content and clinical trial design elements for a future fully powered randomized control trial of the intervention (i.e., R01 proposal).

Enrollment: 15 patients

Sex: All

Ages: 16 to 24 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Past 4-month firearm carriage
• Ownership of a smartphone with APP capabilities

Exclusion criteria

• Non-english speaking patients
• Patients unable to provide informed consent due to mental incompetence, incarceration (i.e., active police custody), medically unstable (abnormal vital signs requiring urgent resuscitation)
• Patients presenting for acute suicidal ideation or acute suicide attempt, child abuse or sexual assault.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

15 participants in 2 patient groups

IntERact

Experimental group

Description:

Participants randomized to this condition will receive behavioral therapy comprised of motivational interviewing, cognitive behavioral skills therapy, and care management. Youth will receive a total of six sessions, one delivered in the emergency department at the time of recruitment and five delivered over the five subsequent weeks after the ED visit (i.e., baseline). Participants will also receive a smartphone APP that will deliver intervention content between therapy sessions, including tailored MI+CBT messages (tailored by daily survey responses), one-touch pro-social contact, psycho-educational materials, GPS-enabled "just-in-time" tailored alerts, and facilitated access to care management resources.

Treatment:

Behavioral: IntERact

Enhanced Usual Care Condition

No Intervention group

Description:

Participants randomized to this condition will receive a pamphlet with violence, mental health, and substance use resources.