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

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



Sponsors


Source

Children's Hospital Medical Center, Cincinnati

Oversight Info

Has Dmc

Yes

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2018-07-01

Completion Date

2019-08-01

Primary Completion Date

2019-07-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change in Psychological Distress, as measured by the Strengths and Difficulties Questionnaire (SDQ)
From baseline to 4 weeks post-injury

Secondary Outcome

Measure

Time Frame

Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form)
From baseline to 4 weeks post-injury
Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS)
From baseline to 4 weeks post-injury
Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)
From baseline to 4 weeks post-injury
Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)
From baseline to 4 weeks post-injury
Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI)
From baseline to 4 weeks post-injury
Change in concussion knowledge, as measured by the Concussion Questionnaire
From baseline to 4 weeks post-injury

Enrollment

100

Condition


Intervention

Intervention Type

Behavioral

Intervention Name


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.

Arm Group Label

SMART Intervention


Eligibility

Criteria

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.

Gender

All

Minimum Age

11 Years

Maximum Age

18 Years

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Lynn Babcock, M.D.
Principal Investigator
Children's Hospital Medical Center, Cincinnati

Overall Contact

Last Name

Lynn Babcock, M.D.

Phone

513-250-5188

Email

lynn.babcock@cchmc.org


Location

Facility

Status

Contact

Cincinnati Children's Hospital Medical Center
Cincinnati Ohio 45229 United States
Not yet recruiting
Last Name: Lynn Babcock, M.D.
Phone: 513-250-5188
Email: lynn.babcock@cchmc.org

Location Countries

Country

United States


Verification Date

2018-04-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

SMART Intervention

Arm Group Type

Experimental


Arm Group Label

Usual Care

Arm Group Type

No Intervention



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Shari Wade, Ph.D

Phone

513-636-3370

Email

shari.wade@cchmc.org


Acronym

SMART

Patient Data

Sharing Ipd

Undecided


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Supportive Care

Masking

None (Open Label)


Study First Submitted

April 4, 2018

Study First Submitted Qc

April 12, 2018

Study First Posted

April 13, 2018

Last Update Submitted

April 12, 2018

Last Update Submitted Qc

April 12, 2018

Last Update Posted

April 13, 2018


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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