Clinical trial NCT03940716: Project IntERact Study
Official title: M-Health to Decrease Youth Substance Misuse & High-Risky Illegal Firearm Behaviors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Substance Use
Criminal Behavior
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-05-07
Enrollment: 15
Sex: ALL
Minimum age (years): 16
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 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Acceptability: enrollment rates
timeFrame: Baseline
measure: Participant Satisfaction (Helpfulness/Likability)
timeFrame: Baseline to 4-month follow-up
measure: Feasibility of Daily Assessments: completion rates of daily assessments
timeFrame: Baseline to Post-Intervention (~5 weeks)
measure: Feasibility of Remote Sessions: Completion rates for Remote Therapy Sessions
timeFrame: Baseline to Post-Intervention (~5 weeks)
measure: Feasibility of 4-month follow-ups: % of eligible enrolled youth who complete follow-up
timeFrame: 4-month Follow-up
measure: Fidelity
timeFrame: Baseline to 4-month Follow-up
Secondary outcomes:
measure: Change in Risky Firearm Behaviors
timeFrame: Baseline to 4-month Follow-up
Other outcomes:
Locations:
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
Study officials:
References: