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Online Therapy for Post-Traumatic Stress Disorder (ReSeT Trial)

N/A
Recruiting
Led By Heather T Keenan, MDCM
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Treated for an injury in the ED or hospitalized
8 years to 17 years at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-weeks
Awards & highlights

ReSeT Trial Summary

This trial will test whether online therapy can help kids with PTSD who have received medical attention for an injury.

Who is the study for?
This trial is for children aged 8-17 who have been treated in the ER or hospitalized for an injury, with internet at home and living with a parent or guardian. They must speak English but can't join if they've had certain psychiatric disorders, are already in psychotherapy, suffered abuse-related injuries, severe brain injury, intellectual disabilities, were hospitalized over 30 days for the injury, or lost a family member/friend at the time of injury.Check my eligibility
What is being tested?
The study tests a web-based educational program combined with telehealth therapy to help kids with post-traumatic stress symptoms after an injury. Participants are randomly split into two groups: one receives this online therapy while the other gets usual care without these additional resources.See study design
What are the potential side effects?
Since this intervention involves non-medical treatment (education and therapy), typical medical side effects aren't expected. However, participants may experience emotional discomfort when discussing traumatic events during sessions.

ReSeT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was treated in the emergency department or was hospitalized for an injury.
Select...
I am between 8 and 17 years old.

ReSeT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-Traumatic Stress Disorder
Secondary outcome measures
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms
Pediatric Quality of Life Inventory (PedsQL)
Anxiety
Other outcome measures
Connor David Resilience Scale
PROMIS Pediatric Anger
PROMIS Pediatric Anxiety
+3 more

ReSeT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RESETExperimental Treatment1 Intervention
Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.
Group II: ControlActive Control1 Intervention
Children will receive usual post-trauma care.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,635 Total Patients Enrolled
University of UtahLead Sponsor
1,098 Previous Clinical Trials
1,778,524 Total Patients Enrolled
Heather T Keenan, MDCMPrincipal InvestigatorUniversity of Utah

Media Library

RESET Clinical Trial Eligibility Overview. Trial Name: NCT04838977 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Control, RESET
Post-Traumatic Stress Disorder Clinical Trial 2023: RESET Highlights & Side Effects. Trial Name: NCT04838977 — N/A
RESET 2023 Treatment Timeline for Medical Study. Trial Name: NCT04838977 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to join this clinical investigation?

"This research study is accepting 106 minors between the ages of 8 and 17 who have experienced moral injury. To be eligible, applicants must satisfy these requirements: age range from 8 to 17 when entering the trial, previous medical attention in an ED or hospital setting for the injury received, AIS score of 2 or higher, English-speaking parent/guardian and patient duo, possession of a broadband internet connection at their residence, and cohabitation with either legal guardian or parent."

Answered by AI

Does this research trial accept applicants aged over twenty?

"The requirements for entry into this trial demand that participants be within the 8-17 age bracket. In total, there are 279 trials available to children below 18 and 814 studies targeted at elderly patients above 65 years of age."

Answered by AI

What is the current enrollment number of this research initiative?

"To conduct this medical experiment, 106 volunteers that meet the pre-defined qualifications are needed. Participants can join from specific sites in Salt Lake City, Utah and Houston, Texas respectively."

Answered by AI

Are participants currently being accepted into this experiment?

"Indeed, clinicaltrials.gov reveals that this experiment is actively recruiting participants since its inception on July 23rd 2021 and last update on March 24th 2022. The research team seeks to recruit 106 patients from 3 distinct medical centres."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Texas
How old are they?
< 18
What site did they apply to?
Cincinnati CHildren's Hospital
University of Texas Health Sciences Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
0
Recent research and studies
clinicaltrials.govStudy
Recovery After Stress Toolkit (RESET) Study
2021. "Recovery After Stress Toolkit (RESET) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04838977.
All > Ptsd Houston
~29 spots leftby Apr 2025
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