Self-Advocacy for Independent Life (SAIL) After TBI

NCT03385824 | Completed

• 1 other identifier: NIDILRR SAIL 2017
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

TBI (Traumatic Brain Injury)

Keywords

traumatic brain injury; advocacy

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (15)

• Personal Advocacy Activity Scale (PAAS)

  Change in PAAS score from Baseline to 11 weeks (immediately post-tx)

• Personal Advocacy Activity Scale (PAAS)

  Change in PAAS score from Baseline to 17 weeks (6 weeks post-tx)

• Personal Advocacy Activity Scale (PAAS)

  Change in PAAS score from Baseline to 23 weeks (12 weeks post-tx)

• General Self Efficacy Scale (GSES)

  Change in GSES score from Baseline to 11 weeks (immediately post-tx)

• General Self Efficacy Scale (GSES)

  Change in GSES score from Baseline to 17 weeks (6 weeks post-tx)

Study Arms (2)

Self-Advocacy for Independent Life (SAIL)

EXPERIMENTAL

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.

Behavioral: Self-Advocacy for Independent Life (SAIL)

Control

NO INTERVENTION

SAIL workbook provided at the conclusion of the study.

Interventions

Self-Advocacy for Independent Life (SAIL) BEHAVIORAL

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.

Self-Advocacy for Independent Life (SAIL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2017
• First Posted: December 29, 2017
• Study Start: February 1, 2018
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)