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NCT Number: NCT07197476

Adolescent Stress and Substance Intervention Subsequent to Trauma

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

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Key information

Conditions

PTSD Acute Stress Disorder Chemically-Induced Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Stress Disorders, Traumatic, Acute Substance Use Disorder (SUD) Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location status: Recruiting

Location contact

Michael J Mello, Doctor of Medicine

CONTACT

[email protected]

401-519-0330

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASSIST Video Intervention

Behavioral

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

Primary outcomes

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

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

    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.

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

    Time frame: From enrollment to the end of the surveys and exit interview at 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, (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.

  3. Develop the ASSIST implementation protocol

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: ASSIST

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 29, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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