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Recruiting NCT07197476

Adolescent Stress and Substance Intervention Subsequent to Trauma

No phase Interventional PTSD Substance Use Disorder (SUD) Acute Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ASSIST Video Intervention.
Who it may be relevant to
Registry conditions: PTSD, Substance Use Disorder (SUD), Acute Stress Disorder. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral ASSIST Video Intervention
    Video intervention for participants: adolescent trauma patient-parent dyads.

Primary outcome measures

  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rhode Island Hospital — Providence

Identifiers

NCT: NCT07197476 · 1R21DA062071 · 1R21DA062071

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗