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Adolescent Stress and Substance Intervention Subsequent to Trauma

Adolescent Injury: Intervening to Prevent Posttraumatic Stress and Substance Use Outcomes

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07197476
Acronym
ASSIST
Enrollment
92
Registered
2025-09-29
Start date
2026-03-03
Completion date
2027-04-01
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

BEHAVIORALASSIST Video Intervention

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

Sponsors

Rhode Island Hospital
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

for Youth: * Must be 12-17 years * Fluent in English or Spanish * Able to provide informed assent * Have a parent able to provide informed consent Inclusion Criteria for Parents: * Live with an admitted pediatric trauma patient * Fluent in English or Spanish * Able to provide informed consent

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

Design outcomes

Primary

MeasureTime frameDescription
To develop and refine two ASSIST video interventions for adolescents and parents admitted to a level 1 pediatric trauma center.Single interaction for enrollment and qualitative interview up to 45 minutesElicit 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.From enrollment to the end of the surveys and exit interview at 3 monthsExamine 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, (when appropriate) engagement with a provider for mental health and/or addiction care. These will be assessed in the form of self-administered surveys and a qualitative exit interview.
Develop the ASSIST implementation protocol3 monthsDevelop 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026