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Completed

NCT Number: NCT03940716

Project IntERact Study

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.

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Key information

Conditions

Violence Behavior Chemically-Induced Disorders Criminal Behavior Mental Disorders Substance Use Substance-Related Disorders

Age range

16 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hurley Medical Center

Flint, Michigan, 48503, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

IntERact

Behavioral

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.

Primary outcomes

  1. Acceptability: enrollment rates

    Time frame: Baseline

    Acceptability will be measured at baseline using study enrollment rates

  2. Participant Satisfaction (Helpfulness/Likability)

    Time frame: Baseline to 4-month follow-up

    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.

  3. Feasibility of Daily Assessments: completion rates of daily assessments

    Time frame: Baseline to Post-Intervention (~5 weeks)

    Feasibility will be measured during the course of the study by examining completion rates of daily assessments.

  4. Feasibility of Remote Sessions: Completion rates for Remote Therapy Sessions

    Time frame: Baseline to Post-Intervention (~5 weeks)

    Completion rates for Remote Therapy Sessions

  5. Feasibility of 4-month follow-ups: % of eligible enrolled youth who complete follow-up

    Time frame: 4-month Follow-up

    Completion rates for 4-month follow-up assessments (i.e., % of eligible enrolled youth who complete follow-up).

  6. Fidelity

    Time frame: Baseline to 4-month Follow-up

    Fidelity will be measured using standard therapy adherence measures coding audio tapings of remote therapy sessions.

Secondary outcomes

  1. Change in Risky Firearm Behaviors

    Time frame: Baseline to 4-month Follow-up

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 7, 2019
Registry last updated
Aug 6, 2021

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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