Project IntERact Study

Substance Use Clinical Trial

Official title:

M-Health to Decrease Youth Substance Misuse & High-Risky Illegal Firearm Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940716
• Other study ID #: HUM00104549
• Secondary ID: K23DA039341
• Status: Completed
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: July 2021
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 24 Years

Eligibility

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.

Related Conditions & MeSH terms

• Criminal Behavior
• Substance Use
• Violence

Intervention

Behavioral:
• IntERact
This intervention integrates motivational interviewing, cognitive behavioral skills therapy, and care management into a single behavioral counseling intervention delivered by a therapist. The intervention is delivered either in the emergency department or remotely over the subsequent 5 weeks for a total of six therapy sessions (~30 min each). A smartphone app is also loaded on the participant's phone and delivers additional behavioral intervention content, including tailored MI+CBT messages (tailored by daily survey responses), one-touch pro-social contact encouragement, psycho-educational materials, GPS-enabled "just-in-time" tailored alerts, and facilitated access to care management resources.

Locations

Country	Name	City	State
United States	Hurley Medical Center	Flint	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability: enrollment rates	Acceptability will be measured at baseline using study enrollment rates	Baseline
Primary	Participant Satisfaction (Helpfulness/Likability)	Participant satisfaction measures of helpfulness and likability will be assessed for individual intervention sessions and content (measured during post-tests after each session and at the 4-month follow-up).; Measures have been used in prior work (Walton 2010) and each item is scored on a 5-point likert scale (1=not at all; 5=extremely) with % of enrolled patients who completed sessions reporting scores of 4 or 5 reporting high likability or helpfulness.	Baseline to 4-month follow-up
Primary	Feasibility of Daily Assessments: completion rates of daily assessments	Feasibility will be measured during the course of the study by examining completion rates of daily assessments.	Baseline to Post-Intervention (~5 weeks)
Primary	Feasibility of Remote Sessions: Completion rates for Remote Therapy Sessions	Completion rates for Remote Therapy Sessions	Baseline to Post-Intervention (~5 weeks)
Primary	Feasibility of 4-month follow-ups: % of eligible enrolled youth who complete follow-up	Completion rates for 4-month follow-up assessments (i.e., % of eligible enrolled youth who complete follow-up).	4-month Follow-up
Primary	Fidelity	Fidelity will be measured using standard therapy adherence measures coding audio tapings of remote therapy sessions.	Baseline to 4-month Follow-up
Secondary	Change in Risky Firearm Behaviors	Composite measure used in prior work (Carter 2019). Composite measure uses items from the Tulane University Youth Study and Conflict Tactics Scale capturing frequency and severity of firearm-related behaviors (e.g., carriage, threats, use, etc.). Items will be summed to create a summary score.	Baseline to 4-month Follow-up