Clinical trial NCT03385824: Self-Advocacy for Independent Life (SAIL) After TBI
Official title: Self-Advocacy for Independent Life (SAIL) After Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: TBI (Traumatic Brain Injury)
Keywords: traumatic brain injury
advocacy
Lead sponsor: Craig Hospital
Sponsor class: OTHER
First posted: 2017-12-29
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Self-Advocacy Scale (SAS)
timeFrame: Change in SAS score from Baseline to 11 weeks (immediately post-tx)
measure: Self-Advocacy Scale (SAS)
timeFrame: Change in SAS score from Baseline to 17 weeks (6 weeks post-tx)
measure: Self-Advocacy Scale (SAS)
timeFrame: Change in SAS score from Baseline to 23 weeks (12 weeks post-tx)
Secondary outcomes:
measure: Personal Advocacy Activity Scale (PAAS)
timeFrame: Change in PAAS score from Baseline to 11 weeks (immediately post-tx)
measure: Personal Advocacy Activity Scale (PAAS)
timeFrame: Change in PAAS score from Baseline to 17 weeks (6 weeks post-tx)
measure: Personal Advocacy Activity Scale (PAAS)
timeFrame: Change in PAAS score from Baseline to 23 weeks (12 weeks post-tx)
measure: General Self Efficacy Scale (GSES)
timeFrame: Change in GSES score from Baseline to 11 weeks (immediately post-tx)
measure: General Self Efficacy Scale (GSES)
timeFrame: Change in GSES score from Baseline to 17 weeks (6 weeks post-tx)
measure: General Self Efficacy Scale (GSES)
timeFrame: Change in GSES score from Baseline to 23 weeks (12 weeks post-tx)
measure: Satisfaction With Life Scale (SWLS)
timeFrame: Change in SWLS score from Baseline to 11 weeks (immediately post-tx)
measure: Satisfaction With Life Scale (SWLS)
timeFrame: Change in SWLS score from Baseline to 17 weeks (6 weeks post-tx)
measure: Satisfaction With Life Scale (SWLS)
timeFrame: Change in SWLS score from Baseline to 23 weeks (12 weeks post-tx)
measure: Flourishing Scale (FS)
timeFrame: Change in total Flourishing Scale score from Baseline to 11 weeks (immediately post-tx)
measure: Flourishing Scale (FS)
timeFrame: Change in total Flourishing Scale from Baseline to 17 weeks (6 weeks post-tx)
measure: Flourishing Scale (FS)
timeFrame: Change in total Flourishing Scale score from Baseline to 23 weeks (12 weeks post-tx)
measure: Participation Assessment with Recombined Tools-Objective (PART-O)
timeFrame: Change in PART-O score from Baseline to 11 weeks (immediately post-tx)
measure: Participation Assessment with Recombined Tools-Objective (PART-O)
timeFrame: Change in PART-O score from Baseline to 17 weeks (6 weeks post-tx)
measure: Participation Assessment with Recombined Tools-Objective (PART-O)
timeFrame: Change in PART-O score from Baseline to 23 weeks (12 weeks post-tx)
Other outcomes:
Locations:
city: Englewood
country: United States
facility: Craig Hospital
state: Colorado
Study officials:
References: