Self-Advocacy for Independent Life (SAIL) After TBI

TBI (Traumatic Brain Injury) Clinical Trial

Official title:

Self-Advocacy for Independent Life (SAIL) After Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03385824
• Other study ID #: NIDILRR SAIL 2017
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2020
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)

Intervention

Behavioral:
• Self-Advocacy for Independent Life (SAIL)
SAIL program is based on an interactive workshop model. In -person sessions will focus on: enhancement of self-efficacy beliefs; enhancement of knowledge of TBI self-advocacy information; group process to instill hope and universality; and practice of self-advocacy behaviors in a supportive neuro-rehabilitation structured group environment.

Locations

Country	Name	City	State
United States	Craig Hospital	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Craig Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-Advocacy Scale (SAS)	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.	Change in SAS score from Baseline to 11 weeks (immediately post-tx)
Primary	Self-Advocacy Scale (SAS)	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.	Change in SAS score from Baseline to 17 weeks (6 weeks post-tx)
Primary	Self-Advocacy Scale (SAS)	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.	Change in SAS score from Baseline to 23 weeks (12 weeks post-tx)
Secondary	Personal Advocacy Activity Scale (PAAS)	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.	Change in PAAS score from Baseline to 11 weeks (immediately post-tx)
Secondary	Personal Advocacy Activity Scale (PAAS)	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.	Change in PAAS score from Baseline to 17 weeks (6 weeks post-tx)
Secondary	Personal Advocacy Activity Scale (PAAS)	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.	Change in PAAS score from Baseline to 23 weeks (12 weeks post-tx)
Secondary	General Self Efficacy Scale (GSES)	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.	Change in GSES score from Baseline to 11 weeks (immediately post-tx)
Secondary	General Self Efficacy Scale (GSES)	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.	Change in GSES score from Baseline to 17 weeks (6 weeks post-tx)
Secondary	General Self Efficacy Scale (GSES)	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.	Change in GSES score from Baseline to 23 weeks (12 weeks post-tx)
Secondary	Satisfaction With Life Scale (SWLS)	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	Change in SWLS score from Baseline to 11 weeks (immediately post-tx)
Secondary	Satisfaction With Life Scale (SWLS)	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	Change in SWLS score from Baseline to 17 weeks (6 weeks post-tx)
Secondary	Satisfaction With Life Scale (SWLS)	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	Change in SWLS score from Baseline to 23 weeks (12 weeks post-tx)
Secondary	Flourishing Scale (FS)	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.	Change in total Flourishing Scale score from Baseline to 11 weeks (immediately post-tx)
Secondary	Flourishing Scale (FS)	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.	Change in total Flourishing Scale from Baseline to 17 weeks (6 weeks post-tx)
Secondary	Flourishing Scale (FS)	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.	Change in total Flourishing Scale score from Baseline to 23 weeks (12 weeks post-tx)
Secondary	Participation Assessment with Recombined Tools-Objective (PART-O)	Objective measure of participation in society	Change in PART-O score from Baseline to 11 weeks (immediately post-tx)
Secondary	Participation Assessment with Recombined Tools-Objective (PART-O)	Objective measure of participation in society	Change in PART-O score from Baseline to 17 weeks (6 weeks post-tx)
Secondary	Participation Assessment with Recombined Tools-Objective (PART-O)	Objective measure of participation in society	Change in PART-O score from Baseline to 23 weeks (12 weeks post-tx)