Project IntERact Study

NCT03940716 | Completed

• 2 other identifiers: HUM00104549K23DA039341
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Violence; Substance Use; Criminal Behavior

Outcome Measures

Primary Outcomes (6)

• Acceptability: enrollment rates

  Acceptability will be measured at baseline using study enrollment rates

  Baseline

• 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

• 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)

• Feasibility of Remote Sessions: Completion rates for Remote Therapy Sessions

  Completion rates for Remote Therapy Sessions

  Baseline to Post-Intervention (~5 weeks)

• 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

• Fidelity

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

  Baseline to 4-month Follow-up

Secondary Outcomes (1)

• Change in Risky Firearm Behaviors

  Baseline to 4-month Follow-up

Study Arms (2)

IntERact

EXPERIMENTAL

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.

Behavioral: IntERact

Enhanced Usual Care Condition

NO INTERVENTION

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

Interventions

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.

IntERact

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Hurley Medical Center

Flint, Michigan, 48503, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Criminal Behavior

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 7, 2019
• Study Start: May 27, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 6, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)