Post-Traumatic Stress Disorder in ChildrenReSeTNCT04838977
Recovery After Stress Toolkit (RESET) Study
A study testing RESET in people with Post-Traumatic Stress Disorder in Children and Post-Traumatic Stress Disorder in Adolescence, run by University of Utah at 3 sites in United States.
Trial summary
This study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (PTSS) after receiving hospital based medical attention for an injury. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Post-Traumatic Stress Disorder in Children, Post-Traumatic Stress Disorder in Adolescence
- What is being tested?
- RESET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jul 2021to 5 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8 years to 17 years at enrollment
- Treated for an injury in the ED or hospitalized
- Abbreviated Injury Scale (AIS) score 2 or greater
- Parent and child English speaking
- Broad band internet availability at home
- Residing with parent or legal guardian
Who cannot join
- Moderate or severe traumatic brain injury (GCS less than 13)
- Diagnosed with moderate or severe intellectual disability
- Pre-existing psychiatric disorder that required hospitalization
- Abuse or interpersonal injury as mechanism of injury
- Currently receiving psychotherapy
- Hospitalized for injury over 30 ays
- Death of a family member or friend at time of injury
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati CHildren's Hospital
Cincinnati, Ohio, 45056
University of Texas Health Sciences Center
Houston, Texas, 77030
University of Utah
Salt Lake City, Utah, 84101
About this study
Official title: Pediatric Injury: Modules to Manage Medical Stress
This study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (PTSS) after receiving hospital based medical attention for an injury. Half of the participants will received the online therapy and half of the participants will receive usual care.
Read the detailed description
As many as 30% of children develop post-traumatic stress symptoms after an injury. Post-traumatic stress symptoms can decrease children's quality of life. Psychological distress may emerge after the child is discharged from the hospital and may go unrecognized. Cognitive behavioral therapy and graduated exposures are standard treatments for PTSS.
- Being tested
- RESET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESETBehavioural
Therapy
| Study group | Role | What they receive |
|---|---|---|
| RESET | Experimental | Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth. Receives: Behavioral: RESET |
| Control | No intervention | Children will receive usual post-trauma care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child PTSD Symptom Scale (CPSS)
17 items listing potential PTSD symptoms scored on a Likert scale of 0 to 3 with 0=Not at all and 3= 5 or more times a week. 7 additional yes/no questions ask if problems interfered with various activities. Higher score is worse. Range 0 to 80. We used the combined child report and parent report. The highest item score from either parent or child was summed.
Measured: 10 weeks post-randomization
Secondary outcomes (3)
Screen for Anxiety Related Emotional Disorders (SCARED)
41-item survey with three point Likert scale responses (not sure, somewhat true, very true) that asks about common difficulties for children with anxiety. Higher scores indicate worse outcomes. Range 0-82
Measured: 10 weeks post-randomization
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms
PROMIS pediatric item bank : 8 questions with a 5-point Likert response from Never to Almost Always. Higher scores means more depressive symptoms. T-score with mean = 50; Standard Deviation (SD)=10.
Measured: 10-weeks post-randomization
Pediatric Quality of Life Inventory (PedsQL)
15 question scale based on physical, emotional, social and school functioning answered on a 5-point Likert scale (never to almost always). Score is 0 - 100 with higher scores indicating better HRQoL. Parent proxy scale.
Measured: 10-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start23 Jul 2021
- Primary completion18 Jan 2024
- Study completion5 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress Disorder in ChildrenStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study comparing treatment to usual care.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Heather T Keenan, MDCM, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04838977
- Sponsor's protocol ID
- HD096350
- Other IDs
- R24HD096350
- Acronym
- ReSeT
- Status last verified
- Aug 2025
- First submitted
- 30 Mar 2021
- Last updated
- 28 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data underlying the trial will be made available 3 years after the last enrolled subject has completed all procedures to investigators who provide a methodologically sound proposal.
Publications
Ewing-Cobbs L, Wade SL, Murphy DM, McNally K, Hickingbotham H, Clark AE, Presson AP, Keenan HT. Reducing Stress After Trauma in Physically Injured Children: A Randomized Clinical Trial. JAMA Pediatr. 2026 Jul 1;180(7):729-738. doi: 10.1001/jamapediatrics.2026.1143.
PubMed 42043806Keenan HT, Wade SL, Miron D, Presson AP, Clark AE, Ewing-Cobbs L. Reducing Stress after Trauma (ReSeT): study protocol for a randomized, controlled trial of an online psychoeducational program and video therapy sessions for children hospitalized after trauma. Trials. 2023 Nov 28;24(1):766. doi: 10.1186/s13063-023-07806-y.
PubMed 38017574
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Injury: Modules to Manage Medical Stress
- ClinicalTrials.gov ID
- NCT04838977
- Acronym / sponsor ID
- ReSeT / HD096350
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 5 Sep 2024 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Posted 28 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the use of web-based educational modules combined with telehealth delivered therapy for children with post-traumatic stress symptoms (PTSS) after receiving hospital based medical attention for an injury. Half of the participants will received the online therapy and half of the participants will receive usual care.
Detailed description
As many as 30% of children develop post-traumatic stress symptoms after an injury. Post-traumatic stress symptoms can decrease children's quality of life. Psychological distress may emerge after the child is discharged from the hospital and may go unrecognized. Cognitive behavioral therapy and graduated exposures are standard treatments for PTSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Study comparing treatment to usual care.
| Arm | Type | Receives |
|---|---|---|
| RESET | Experimental | Behavioral: RESETChildren will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth. |
| Control | No intervention | –Children will receive usual post-trauma care. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 8 years to 17 years at enrollment
- Treated for an injury in the ED or hospitalized
- Abbreviated Injury Scale (AIS) score 2 or greater
- Parent and child English speaking
- Broad band internet availability at home
Key exclusion criteria (7 listed)
- Moderate or severe traumatic brain injury (GCS less than 13)
- Diagnosed with moderate or severe intellectual disability
- Pre-existing psychiatric disorder that required hospitalization
- Abuse or interpersonal injury as mechanism of injury
- Currently receiving psychotherapy
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 |
|---|---|---|
| RESETTherapy | Behavioural | RESET |
Primary outcome
Child PTSD Symptom Scale (CPSS)
Time frame: 10 weeks post-randomization
17 items listing potential PTSD symptoms scored on a Likert scale of 0 to 3 with 0=Not at all and 3= 5 or more times a week. 7 additional yes/no questions ask if problems interfered with various activities. Higher score is worse. Range 0 to 80. We used the combined child report and parent report. The highest item score from either parent or child was summed.
3 secondary outcomes
Screen for Anxiety Related Emotional Disorders (SCARED)
Time frame: 10 weeks post-randomization
Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms
Time frame: 10-weeks post-randomization
Pediatric Quality of Life Inventory (PedsQL)
Time frame: 10-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42043806Ewing-Cobbs L, Wade SL, Murphy DM, McNally K, Hickingbotham H, Clark AE, Presson AP, Keenan HT. Reducing Stress After Trauma in Physically Injured Children: A Randomized Clinical Trial. JAMA Pediatr. 2026 Jul 1;180(7):729-738. doi: 10.1001/jamapediatrics.2026.1143.
- Derived from this study: PubMed 38017574Keenan HT, Wade SL, Miron D, Presson AP, Clark AE, Ewing-Cobbs L. Reducing Stress after Trauma (ReSeT): study protocol for a randomized, controlled trial of an online psychoeducational program and video therapy sessions for children hospitalized after trauma. Trials. 2023 Nov 28;24(1):766. doi: 10.1186/s13063-023-07806-y.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data underlying the trial will be made available 3 years after the last enrolled subject has completed all procedures to investigators who provide a methodologically sound proposal.
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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. This study is not recruiting at the moment.
Heather T Keenan, MDCM principal investigator
University of Utah
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESET in people with Post-Traumatic Stress Disorder in Children and Post-Traumatic Stress Disorder in Adolescence, run by University of Utah at 3 sites 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 28 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child PTSD Symptom Scale (CPSS) (time frame: 10 weeks post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04838977, which also lists 2 linked publications.
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 28 Aug 2025.