Recovery After Stress Toolkit (RESET) Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-23

Study Completion Date

2024-09-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Post-Traumatic Stress Disorder in Children Post-Traumatic Stress Disorder in Adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study comparing treatment to usual care.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Investigators will not be aware of study assignment.

Study Groups

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RESET

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

Group Type EXPERIMENTAL

RESET

Intervention Type BEHAVIORAL

Therapy

Control

Children will receive usual post-trauma care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RESET

Therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No