Adolescent Stress and Substance Intervention Subsequent to Trauma

Not Applicable

Not yet recruiting

• Conditions: PTSD; Substance Use Disorder (SUD); Acute Stress Disorder

• Registration Number: NCT07197476
• Lead Sponsor: Rhode Island Hospital

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-19
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Study Start: 2026-01-01
• Primary Completion: 2027-04
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center.	30 days	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.
To evaluate the feasibility, acceptability, and implementation potential of the ASSIST video interventions.	3 months	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.
Develop the ASSIST implementation protocol	3 months	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.