Self-Advocacy for Independent Life (SAIL) After TBI

Craig Hospital

Status: Completed

Conditions: TBI (Traumatic Brain Injury)

Treatments: Behavioral: Self-Advocacy for Independent Life (SAIL)

Study type: Interventional

Funder types: Other

Identifiers

NCT03385824

NIDILRR SAIL 2017

Details and patient eligibility

About

Traumatic brain injury (TBI) has been conceptualized as a chronic health condition, warranting self-advocacy for health management services across the lifespan. Successful self-advocacy requires a combination of cognitive and communication skills (problem solving, organization, negotiation, etc), which may be impaired following TBI. This project focuses on developing and testing the efficacy of an intervention to enhance self-advocacy skills in individuals who have sustained TBI. This two-arm, randomized controlled trial will include approximately 74 participants, recruited in 4 waves of approximately 18-20 per wave, with each wave recruited from a different geographic area of the state. The primary hypothesis states that participants receiving the treatment intervention will demonstrate significantly greater improvements in self-advocacy beliefs (SAS) from baseline to post-intervention as compared to participants in the control group. Treatment will consist of interactive 4-session workshops along with 2 booster phone calls. Control participants will receive a copy of a self-advocacy workbook after all assessments are completed. Baseline, post-treatment and two follow-up assessments will take place.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented TBI due to an external mechanical force
• Received inpatient or outpatient rehabilitation for TBI
• At least 9 months post TBI
• Able to travel independently in the community
• Able to attend intervention sessions

Exclusion criteria

• Unable to read or speak English well enouth to complete assessments and actively participate in study intervention
• Currently in inpatient TBI rehabilitation
• Previously participated in a SAIL program
• Participating in another research trial
• Unable to perform neuropsychological baseline assessment
• Score of 30 or above on GSES

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Self-Advocacy for Independent Life (SAIL)

Experimental group

Description:

10 week treatment program to improve self-advocacy skills. Includes 4 in-person group sessions (3 hours per session) and two supportive phone calls; workbook and home assignments.

Treatment:

Behavioral: Self-Advocacy for Independent Life (SAIL)

Control

No Intervention group

Description:

SAIL workbook provided at the conclusion of the study.