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RecruitingNCT07197476ASSISTUpdated Jul 9, 2026

Adolescent Stress and Substance Intervention Subsequent to Trauma

An interventional study of ASSIST Video Intervention in PTSD, Substance Use Disorder (SUD) and Acute Stress Disorder, sponsored by Rhode Island Hospital. Recruiting at 1 site in United States. Open to participants aged 12 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Rhode Island Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
92
Allocation
Not applicable
Ages
12 Years to 17 Years
Sex
All
01

Study 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
02

Conditions studied

03

Who can participate

Ages eligible
12 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
92 participants (estimated)

Study arms

  • Experimental
    Develop and Pilot Test ASSIST Video Intervention

    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

  • BehavioralASSIST Video Intervention

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Single interaction for enrollment and qualitative interview up to 45 minutes

  2. 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, (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.

    Time frame: From enrollment to the end of the surveys and exit interview at 3 months

  3. 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.

    Time frame: 3 months

06

Study locations

1 of 1 sites recruiting
  • Rhode Island Hospital
    Providence, Rhode Island 02903, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT07197476
Lead sponsor
Rhode Island Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Sponsor
First posted
Sep 29, 2025
Start date
Mar 3, 2026
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Jul 9, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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