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Project IntERact Study

Primary Purpose

Violence, Substance Use, Criminal Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IntERact
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Violence

Eligibility Criteria

16 Years - 24 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • Hurley Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IntERact

Enhanced Usual Care Condition

Arm 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.

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

Outcomes

Primary Outcome Measures

Acceptability: enrollment rates
Acceptability will be measured at baseline using study enrollment rates
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.
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.
Feasibility of Remote Sessions: Completion rates for Remote Therapy Sessions
Completion rates for Remote Therapy Sessions
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).
Fidelity
Fidelity will be measured using standard therapy adherence measures coding audio tapings of remote therapy sessions.

Secondary Outcome Measures

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.

Full Information

First Posted
April 30, 2019
Last Updated
July 30, 2021
Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03940716
Brief Title
Project IntERact Study
Official Title
M-Health to Decrease Youth Substance Misuse & High-Risky Illegal Firearm Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 27, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Violence, Substance Use, Criminal Behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IntERact
Arm Type
Experimental
Arm 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.
Arm Title
Enhanced Usual Care Condition
Arm Type
No Intervention
Arm Description
Participants randomized to this condition will receive a pamphlet with violence, mental health, and substance use resources.
Intervention Type
Behavioral
Intervention Name(s)
IntERact
Intervention Description
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 Outcome Measure Information:
Title
Acceptability: enrollment rates
Description
Acceptability will be measured at baseline using study enrollment rates
Time Frame
Baseline
Title
Participant Satisfaction (Helpfulness/Likability)
Description
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.
Time Frame
Baseline to 4-month follow-up
Title
Feasibility of Daily Assessments: completion rates of daily assessments
Description
Feasibility will be measured during the course of the study by examining completion rates of daily assessments.
Time Frame
Baseline to Post-Intervention (~5 weeks)
Title
Feasibility of Remote Sessions: Completion rates for Remote Therapy Sessions
Description
Completion rates for Remote Therapy Sessions
Time Frame
Baseline to Post-Intervention (~5 weeks)
Title
Feasibility of 4-month follow-ups: % of eligible enrolled youth who complete follow-up
Description
Completion rates for 4-month follow-up assessments (i.e., % of eligible enrolled youth who complete follow-up).
Time Frame
4-month Follow-up
Title
Fidelity
Description
Fidelity will be measured using standard therapy adherence measures coding audio tapings of remote therapy sessions.
Time Frame
Baseline to 4-month Follow-up
Secondary Outcome Measure Information:
Title
Change in Risky Firearm Behaviors
Description
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.
Time Frame
Baseline to 4-month Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Project IntERact Study

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