NCT04838977

Brief 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. Half of the participants will received the online therapy and half of the participants will receive usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 23, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

August 28, 2025

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

March 30, 2021

Results QC Date

July 23, 2025

Last Update Submit

August 12, 2025

Conditions

Post-Traumatic Stress Disorder in ChildrenPost-Traumatic Stress Disorder in Adolescence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Screen for Anxiety Related Emotional Disorders (SCARED)

    10 weeks post-randomization

  • Patient Reported Outcome Measurement Information System (PROMIS) Pediatric Depressive Symptoms

    10-weeks post-randomization

  • Pediatric Quality of Life Inventory (PedsQL)

    10-weeks

Other Outcomes (6)

  • Connor David Resilience Scale

    10-weeks

  • PROMIS Pediatric Anger

    10-weeks post-randomization

  • PROMIS Pediatric Psychological Stress Experience

    10-weeks post-randomization

  • +3 more other outcomes

Study Arms (2)

RESET

EXPERIMENTAL

Children will view 8 educational modules online and participate in 8 sessions with a therapist via telehealth.

Behavioral: RESET

Control

NO INTERVENTION

Children will receive usual post-trauma care.

Interventions

RESETBEHAVIORAL

Therapy

RESET

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cincinnati CHildren's Hospital

Cincinnati, Ohio, 45056, United States

Location

University of Texas Health Sciences Center

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84101, United States

Location

Related Publications (1)

  • 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.

    PMID: 38017574DERIVED

Results Point of Contact

Title
Heather Keenan
Organization
University of Utah
heather.keenan@hsc.utah.edu
8015877567

Study Officials

  • Heather T Keenan, MDCM

    University of Utah

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigators will not be aware of study assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study comparing treatment to usual care.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 9, 2021

Study Start

July 23, 2021

Primary Completion

January 18, 2024

Study Completion

September 5, 2024

Last Updated

August 28, 2025

Results First Posted

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
36 months after last subject has completed all procedures. Data will be available for 36 months.
Access Criteria
Investigators who provide a methodologically sound proposal

Locations

US(3)