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Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program for Kids With Mild Traumatic Brain Injury (SMART)

Primary Purpose

Brain Injury Traumatic Mild

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Self-Monitoring Activity-restriction and Relaxation Training (SMART)

About this trial

This is an interventional supportive care trial for Brain Injury Traumatic Mild

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

11-18 years old
Sustained mTBI within the past week

Exclusion Criteria:

Patient and/or family do not speak and read English
Patient and/or family do not have Internet access
Patient experiencing more severe brain injury (Glasgow coma score <13)
Patient with more than one moderate extracranial injury
Patients with non-mTBI reasons for altered mental status
Patients with severe pre-existing neurologic or cognitive disorders or other disorders that may impair ability to participate in the intervention.

Sites / Locations

Cincinnati Children's Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMART Intervention

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)

The PedsQL includes 23 items measuring physical, emotional, social, and school functioning.

Secondary Outcome Measures

Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form)

The CSI-S is a coping styles measure and has been used with other pediatric TBI samples. Adolescents rate how much they agree with 32-statements regarding different ways of coping with difficult situations on a 5-point Likert scale. Responses are then grouped into primary subscales reflecting eight different coping strategies (e.g., problem-solving, problem avoidance, social withdrawal, etc.).

Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS)

This 2-item measure will be developed by the research team based on Bandura's self-efficacy theory. Adolescents will rate their level of confidence that they are able to maintain a plan to manage their symptoms each week

Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)

PROMIS collects data from the adolescent participant and the parent about the impact a condition has on the adolescent's functioning.

Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI)

The HBI is a 20-item questionnaire which includes a variety of cognitive, somatic, emotional, and behavioral symptoms requiring parents and adolescents to rate the frequency of occurrence of each symptom over the past week on a 4-point scale, ranging from "never" to "often."

Full Information

NCT ID

NCT03498495

First Posted

April 4, 2018

Last Updated

July 6, 2023

Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

University of Cincinnati

1. Study Identification

Unique Protocol Identification Number

NCT03498495

Brief Title

Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program for Kids With Mild Traumatic Brain Injury

Acronym

SMART

Official Title

Kids With mTBI Get SMART: Development and Pilot Trial of a Web-Based Self-Monitoring Activity-Restriction and Relaxation Training Program

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

May 12, 2019 (Actual)

Primary Completion Date

August 31, 2020 (Actual)

Study Completion Date

August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Hospital Medical Center, Cincinnati

Collaborators

University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

SMART is an interactive web-based program that will allow youth with mild traumatic brain injuries (mTBI) to monitor their symptoms and receive education on problem-solving and coping strategies. This study will evaluate the effectiveness of SMART as a means of improving symptom-management, coping skills, and general well-being during recovery from mTBI. Half of participants will receive the SMART intervention, while half will receive usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injury Traumatic Mild

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SMART Intervention

Arm Type

Experimental

Arm Title

Usual Care

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Self-Monitoring Activity-restriction and Relaxation Training (SMART)

Intervention Description

SMART integrates real-time self-monitoring of symptoms and activities with interactive modules designed to increase self-efficacy through psychoeducation and training in problem solving/problem-focused coping strategies.

Primary Outcome Measure Information:

Title

Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)

Description

The PedsQL includes 23 items measuring physical, emotional, social, and school functioning.

Time Frame