Adolescent Stress and Substance Intervention Subsequent to Trauma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorRhode Island Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Must be 12-17 years
Fluent in English or Spanish
Able to provide informed assent
Have a parent able to provide informed consent
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ASSIST Video Intervention
BehavioralVideo intervention for participants: adolescent trauma patient-parent dyads.
Treatment groups
92 Participants
are divided into 1 treatment groupGroup A: Develop and Pilot Test ASSIST Video InterventionExperimental treatment 1 intervention
Trial outcomes
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 minutes2
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 months3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rhode Island Hospital
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov