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| ID | Type | Description | Link |
|---|---|---|---|
| R24HD096350 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RESET | Experimental | Children 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RESET | Behavioral | Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 weeks post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 weeks post-randomization |
| Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Connor David Resilience Scale | 10-item scale with LIkert response from 0 - not true to 4=true nearly all of the time. Range is 0 to 40 with higher scores indicating more resilience (better). | 10-weeks |
| PROMIS Pediatric Anger |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather T Keenan, MDCM | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati CHildren's Hospital | Cincinnati | Ohio | 45056 | United States | ||
| University of Texas Health Sciences Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42043806 | Derived | 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 Apr 27:e261143. doi: 10.1001/jamapediatrics.2026.1143. Online ahead of print. | |
| 38017574 | Derived | Keenan 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. |
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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.
36 months after last subject has completed all procedures. Data will be available for 36 months.
Investigators who provide a methodologically sound proposal
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130 children eligible for randomization No consent obtained = 37
Reasons:
Currently receiving psychotherapy (exclusion criteria), n=5 Parent felt too much time required, n=6 Participant no longer interested, n=9 No reason given/unknown, n=8 Other reason, n=9
93 children randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | RESET | Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth. |
| FG001 | Control | Children will receive usual post-trauma care. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | RESET | Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth. RESET: Therapy |
| BG001 | Control | Children will receive usual post-trauma care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | We had 3 children not complete the intervention and 4 controls not complete the final data collection as shown in participant flow. | Posted | Mean | Standard Deviation | Score on a scale | 10 weeks post-randomization |
|
From enrollment in the trial until completion of therapy or at 10 weeks dependent on arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Children will receive usual post-trauma care. Control: Usual care | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Keenan | University of Utah | 8015877567 | heather.keenan@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2023 | Aug 12, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 5, 2022 | Nov 13, 2023 | ICF_000.pdf |
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Study comparing treatment to usual care.
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Investigators will not be aware of study assignment.
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. |
| 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. | 10-weeks |
5 question PROMIS measure answered with a 5-point Likert scale. A higher score indicates more anger (worse). T-score with mean = 50; SD = 10.
| 10-weeks post-randomization |
| PROMIS Pediatric Psychological Stress Experience | 8-question PROMIS measure answered with a 5-point Likert scale. A higher score is more stress (worse). T-score with mean 50; SD 10. | 10-weeks post-randomization |
| PROMIS Pediatric Physical Stress Experience | 8-question PROMIS measure answered on a 5-point Likert scale. A higher score is more physical stress (worse). T-score with mean 50; SD 10. | 10-weeks |
| PROMIS Pediatric Anxiety | 8-question PROMIS measure answered on a 5-point LIkert scale. A higher score is more anxiety (worse). T-score with mean 50; SD 10. | 10-weeks |
| PROMIS Pediatric Global Health | Seven questions about global health with 5-point Likert response from excellent to poor. A higher score is more poor health (worse). T-score with mean 50; SD 10. | 10-weeks |
| Houston |
| Texas |
| 77030 |
| United States |
| University of Utah | Salt Lake City | Utah | 84101 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| CPSS | We measured the combined parent-child CPSS prior to randomization which served as the baseline. | Mean | Standard Deviation | CPSS score |
|
| Control |
Children will receive usual post-trauma care. |
|
|
|
| Secondary | 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 | Some participants did not complete the measure. | Posted | Mean | Standard Deviation | Score on a scale | 10 weeks post-randomization |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | 10-weeks post-randomization |
|
|
|
| Secondary | 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. | Some participants did not complete all scales. | Posted | Mean | Standard Deviation | Score on a scale | 10-weeks |
|
|
|
| Other Pre-specified | Connor David Resilience Scale | 10-item scale with LIkert response from 0 - not true to 4=true nearly all of the time. Range is 0 to 40 with higher scores indicating more resilience (better). | Posted | Mean | Standard Deviation | Score on a scale | 10-weeks |
|
|
|
| Other Pre-specified | PROMIS Pediatric Anger | 5 question PROMIS measure answered with a 5-point Likert scale. A higher score indicates more anger (worse). T-score with mean = 50; SD = 10. | Posted | Mean | Standard Deviation | Score on a scale | 10-weeks post-randomization |
|
|
|
| Other Pre-specified | PROMIS Pediatric Psychological Stress Experience | 8-question PROMIS measure answered with a 5-point Likert scale. A higher score is more stress (worse). T-score with mean 50; SD 10. | Not all children completed all measures. | Posted | Mean | Standard Deviation | Score on a scale | 10-weeks post-randomization |
|
|
|
| Other Pre-specified | PROMIS Pediatric Physical Stress Experience | 8-question PROMIS measure answered on a 5-point Likert scale. A higher score is more physical stress (worse). T-score with mean 50; SD 10. | Not all children completed all of the measures. | Posted | Mean | Standard Deviation | Score on a scale | 10-weeks |
|
|
|
| Other Pre-specified | PROMIS Pediatric Anxiety | 8-question PROMIS measure answered on a 5-point LIkert scale. A higher score is more anxiety (worse). T-score with mean 50; SD 10. | Not all children completed all of the measures. | Posted | Mean | Standard Deviation | Score on a scale | 10-weeks |
|
|
|
| Other Pre-specified | PROMIS Pediatric Global Health | Seven questions about global health with 5-point Likert response from excellent to poor. A higher score is more poor health (worse). T-score with mean 50; SD 10. | Not all children completed all of the measures. | Posted | Mean | Standard Deviation | Score on a scale | 10-weeks |
|
|
|
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | RESET | Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth. RESET: Therapy | 0 | 47 | 0 | 47 | 0 | 47 |
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