Adolescent Stress and Substance Intervention Subsequent to Trauma

NCT07197476 | Recruiting DMC

• 1 other identifier: 1R21DA062071
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The long-term goal of this study is to address the adoption of the new trauma center requirement to establish best practices of screening for acute stress with an intervention to prevent both adolescent PTSD and substance use. The investigators will develop, refine, and pilot test the Adolescent Stress and Substance Intervention Subsequent to Trauma (ASSIST) video interventions that build upon the American College of Surgeons Committee on Trauma guidelines to improve mental health care during and after hospitalization for traumatic injury. The aims are: PHASE I - Primary Aim 1: To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center. PHASE II

• Primary Aim 2a: To evaluate the feasibility, acceptability and implementation potential of the ASSIST video interventions.
• Primary Aim 2b: Develop the ASSIST implementation protocol using a national advisory panel of pediatric trauma center leaders. Participants in PHASE 1: Parent and child duo:
• Review storyboards for the video interventions
• Participate in qualitative interviews at hospital admission and 1 month following discharge Pediatric trauma center clinical staff members: \- Complete qualitative interviews Participants in PHASE II: Parent and child duo:
• Shown their own video interventions
• Complete assessments at admission and 1-, 2-, 3- months after discharge

Conditions

PTSD; Substance Use Disorder (SUD); Acute Stress Disorder

Outcome Measures

Primary Outcomes (3)

• To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center.

  Elicit feedback from content experts to further refine initial ASSIST video interventions. Conduct qualitative interviews with 15-20 parents and adolescents (12-17 years) to assess perceived usefulness of, and satisfaction with, intervention content as well as elicit feedback on areas for future refinement. Conduct qualitative interviews with 9-12 key stakeholders in the fields of pediatric trauma care to assess clinical concerns/strategies as well as implementation barriers/facilitators.

  30 days

• To evaluate the feasibility, acceptability, and implementation potential of the ASSIST video interventions.

  Examine the feasibility and acceptability of the ASSIST videos, over a 3-month period, as measured by rates of enrollment and retention, interest/satisfaction, knowledge regarding mental health symptoms/substance use, incidence (quantity/frequency) of substance use, self-efficacy in having discussions about mental health symptoms/ substance use, self-efficacy around connecting participant's child to mental health and/or addiction resources, and (when appropriate) engagement with a provider for mental health and/or addiction care.

  3 months

• Develop the ASSIST implementation protocol

  Develop the ASSIST implementation protocol using a national advisory panel of pediatric trauma center leaders. Using an expert panel from the national cohort of pediatric trauma centers the investigators have worked with in a previous implementation trial, and pilot data from the investigators' institution, an implementation protocol will be developed that will be tested in a subsequent fully powered R01 hybrid implementation-efficacy trial.

  3 months

Study Arms (1)

Develop and Pilot Test ASSIST Video Intervention

EXPERIMENTAL

The investigators will develop and pilot test the Adolescent Stress and Substance Intervention Subsequent to Trauma (ASSIST) video intervention that builds upon ACS-COT guidelines to improve mental health care during and after hospitalization for traumatic injury. The ASSIST video intervention is a simple, cost-effective, and scalable tool that may be easily integrated into usual care settings to address posttraumatic symptoms and decrease risk of subsequent substance use following discharge.

Behavioral: ASSIST Video Intervention

Interventions

ASSIST Video Intervention BEHAVIORAL

Video intervention for participants: adolescent trauma patient-parent dyads.

Develop and Pilot Test ASSIST Video Intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Must be 12-17 years
• Fluent in English or Spanish
• Able to provide informed assent
• Have a parent able to provide informed consent
• Live with an admitted pediatric trauma patient
• Fluent in English or Spanish
• Able to provide informed consent

You may not qualify if:

• Prisoner or in police custody
• Involvement with child protective services
• Admitted due to suicide attempt or non-suicidal self-injury
• Any acute condition that would preclude provision of informed consent or assent

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Rhode Island Hospital: lead

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders; Stress Disorders, Traumatic, Acute

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 29, 2025
• Study Start: March 3, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2025-09

Locations

US (1)