Adolescent Stress and Substance Intervention Subsequent to Trauma

NCT ID: NCT07197476

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-04-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ASSIST Video Intervention

Intervention Type: BEHAVIORAL

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

Interventions

ASSIST Video Intervention

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Must be 12-17 years
• Fluent in English or Spanish
• Able to provide informed assent
• Have a parent able to provide informed consent

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

1R21DA062071

Identifier Type: NIH

Identifier Source: secondary_id

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1R21DA062071

Identifier Type: NIH

Identifier Source: org_study_id

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