Self-Advocacy for Independent Life (SAIL) After TBI

Not Applicable

Completed

• Conditions: TBI (Traumatic Brain Injury)
• Interventions: Behavioral: Self-Advocacy for Independent Life (SAIL)

• Registration Number: NCT03385824
• Lead Sponsor: Craig Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-19
• Study First Submitted QC: 2017-12-27
• Study First Posted: 2017-12-29
• Study Start: 2018-02-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Self-Advocacy for Independent Life (SAIL)	Self-Advocacy for Independent Life (SAIL)	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.

Primary Outcome Measures

Name	Time	Method
Self-Advocacy Scale (SAS)	Change in SAS score from Baseline to 23 weeks (12 weeks post-tx)	The Self-Advocacy Scale (SAS) is an eight-item 1-4 Likert rating scale (1 = not confident to 4 = very confident), conceptualized as a domain specific self-efficacy scale. The SAS is designed to measure an individual's current beliefs about his or her ability to produce desired self-advocacy outcomes. Scores range from 8 to 32 with higher scores indicative of better self-advocacy skills.

Secondary Outcome Measures

Name	Time	Method
Personal Advocacy Activity Scale (PAAS)	Change in PAAS score from Baseline to 23 weeks (12 weeks post-tx)	The Personal Advocacy Activity Scale (PAAS) is a 12-item self-rating of personal advocacy behaviors. Participants respond to each item by indicating how frequently they perform each activity, "Not at all", "1 - 4 times", or "5 or more times". Scores range from 12 to 36 with higher scores indicating more personal advocacy behavior.
General Self Efficacy Scale (GSES)	Change in GSES score from Baseline to 23 weeks (12 weeks post-tx)	General Self Efficacy Scale (GSES) is a 10-item Likert rating scale assessing beliefs about one's ability to cope with various demands in life, a core component of self-advocacy.The GSES produces a single score ranging from 10 to 40, with higher scores indicating greater general self-efficacy.
Satisfaction With Life Scale (SWLS)	Change in SWLS score from Baseline to 23 weeks (12 weeks post-tx)	The Satisfaction with Life Scale (SWLS) is a subjective, five-item 1-7 Likert rating scale measuring global life satisfaction - a cognitive self-assessment of quality of life. Scores range from 5 to 35 with higher scores indicative of greater life satisfaction
Flourishing Scale (FS)	Change in total Flourishing Scale score from Baseline to 23 weeks (12 weeks post-tx)	The Flourishing Scale (FS) is a brief eight-item, self-rated, 1-7 point Likert scale measure of self-perceived success in areas such as social relationships, self-esteem, and purpose in life. Scores range from 5 to 35 with higher scores indicating better self-perceived success.
Participation Assessment with Recombined Tools-Objective (PART-O)	Change in PART-O score from Baseline to 23 weeks (12 weeks post-tx)	Objective measure of participation in society

Trial Locations

Locations (1)

Craig Hospital; 🇺🇸 Englewood, Colorado, United States