Recruiting

ASSIST Intervention

Sponsor:

Rhode Island Hospital

Code:

NCT07197476

Conditions

PTSD

Substance Use Disorder (SUD)

Acute Stress Disorder

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

ASSIST Video Intervention

Study Details

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

Study ID

NCT07197476

Start date

Mar 3, 2026

Status verified date

Jul, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

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

Study Design

Enrollment

92 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

ASSIST Video Intervention

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

Primary outcome measure

  • 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 ]
  • 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 ]
  • Develop the ASSIST implementation protocol [ Time Frame: 3 months ]

Central Contacts and Locations

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Michael J Mello, Doctor of Medicine

401-519-0330mjmello@brownhealth.org

More Information

Sponsor

Rhode Island Hospital

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2026-07-09.