PTSDASSISTNCT07197476
Adolescent Stress and Substance Intervention Subsequent to Trauma
A study testing ASSIST Video Intervention in people with PTSD and Substance Use Disorder (SUD), run by Rhode Island Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, Substance Use Disorder (SUD), Acute Stress Disorder
- What is being tested?
- ASSIST Video Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Mar 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Michael J Mello, Doctor of Medicine, 401-519-0330, mjmello@brownhealth.org
About this study
Official title: Adolescent Injury: Intervening to Prevent Posttraumatic Stress and Substance Use Outcomes
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.
Read more
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
- Being tested
- ASSIST Video Intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders, Stress Disorders, Traumatic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSIST Video InterventionBehavioural
Video intervention for participants: adolescent trauma patient-parent dyads.
| Study group | Role | What they receive |
|---|---|---|
| Develop and Pilot Test ASSIST Video Intervention | Experimental | 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. Receives: Behavioral: ASSIST Video Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single interaction for enrollment and qualitative interview up to 45 minutes
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.
Measured: From enrollment to the end of the surveys and exit interview at 3 months
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start3 Mar 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197476
- Sponsor's protocol ID
- 1R21DA062071
- Other IDs
- 1R21DA062071
- Acronym
- ASSIST
- Status last verified
- Jul 2026
- First submitted
- 19 Sep 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Injury: Intervening to Prevent Posttraumatic Stress and Substance Use Outcomes
- ClinicalTrials.gov ID
- NCT07197476
- Acronym / sponsor ID
- ASSIST / 1R21DA062071
- Conditions
- PTSD, Substance Use Disorder (SUD), Acute Stress Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Develop and Pilot Test ASSIST Video Intervention | Experimental | Behavioral: ASSIST Video InterventionThe 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASSIST Video InterventionVideo intervention for participants: adolescent trauma patient-parent dyads. | Behavioural | Develop and Pilot Test ASSIST Video Intervention |
Primary outcome
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASSIST Video Intervention in people with PTSD and Substance Use Disorder (SUD), run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.