Self-Advocacy for Independent Life (SAIL) After TBI

NCT ID: NCT03385824

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2020-03-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Self-Advocacy for Independent Life (SAIL)

Intervention Type: 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.

Control

SAIL workbook provided at the conclusion of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lenore Hawley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Craig Hospital

Englewood, Colorado, United States

Countries

United States

Other Identifiers

NIDILRR SAIL 2017

Identifier Type: -

Identifier Source: org_study_id