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Self-Advocacy for Independent Life (SAIL) After TBI

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ClinicalTrials.gov Identifier: NCT03385824
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Lenore Hawley, Craig Hospital

December 19, 2017
December 29, 2017
August 2, 2018
February 1, 2018
January 31, 2020   (Final data collection date for primary outcome measure)
  • Self-Advocacy Scale (SAS) [ Time Frame: Change in SAS score from Baseline to 11 weeks (immediately 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.
  • Self-Advocacy Scale (SAS) [ Time Frame: Change in SAS score from Baseline to 17 weeks (6 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.
  • Self-Advocacy Scale (SAS) [ Time Frame: 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.
  • Self-Advocacy Scale (SAS) [ Time Frame: Change in SAS score from Baseline to 11 weeks (immediately post-tx) ]
    Measures current beliefs about ability to produce desired self-advocacy outcomes
  • Self-Advocacy Scale (SAS) [ Time Frame: Change in SAS score from Baseline to 17 weeks (6 weeks post-tx) ]
    Measures current beliefs about ability to produce desired self-advocacy
  • Self-Advocacy Scale (SAS) [ Time Frame: Change in SAS score from Baseline to 23 weeks (12 weeks post-tx) ]
    Measures current beliefs about ability to produce desired self-advocacy
Complete list of historical versions of study NCT03385824 on ClinicalTrials.gov Archive Site
  • Personal Advocacy Activity Scale (PAAS) [ Time Frame: Change in PAAS score from Baseline to 11 weeks (immediately 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.
  • Personal Advocacy Activity Scale (PAAS) [ Time Frame: Change in PAAS score from Baseline to 17 weeks (6 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.
  • Personal Advocacy Activity Scale (PAAS) [ Time Frame: 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) [ Time Frame: Change in GSES score from Baseline to 11 weeks (immediately 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.
  • General Self Efficacy Scale (GSES) [ Time Frame: Change in GSES score from Baseline to 17 weeks (6 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.
  • General Self Efficacy Scale (GSES) [ Time Frame: 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) [ Time Frame: Change in SWLS score from Baseline to 11 weeks (immediately 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
  • Satisfaction With Life Scale (SWLS) [ Time Frame: Change in SWLS score from Baseline to 17 weeks (6 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
  • Satisfaction With Life Scale (SWLS) [ Time Frame: 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) [ Time Frame: Change in total Flourishing Scale score from Baseline to 11 weeks (immediately 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.
  • Flourishing Scale (FS) [ Time Frame: Change in total Flourishing Scale from Baseline to 17 weeks (6 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.
  • Flourishing Scale (FS) [ Time Frame: 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) [ Time Frame: Change in PART-O score from Baseline to 11 weeks (immediately post-tx) ]
    Objective measure of participation in society
  • Participation Assessment with Recombined Tools-Objective (PART-O) [ Time Frame: Change in PART-O score from Baseline to 17 weeks (6 weeks post-tx) ]
    Objective measure of participation in society
  • Participation Assessment with Recombined Tools-Objective (PART-O) [ Time Frame: Change in PART-O score from Baseline to 23 weeks (12 weeks post-tx) ]
    Objective measure of participation in society
  • Personal Advocacy Activity Scale (PAAS) [ Time Frame: Change in PAAS score from Baseline to 11 weeks (immediately post-tx) ]
    Self-rating of personal advocacy behaviors
  • Personal Advocacy Activity Scale (PAAS) [ Time Frame: Change in PAAS score from Baseline to 17 weeks (6 weeks post-tx) ]
    Self-rating of personal advocacy behaviors
  • Personal Advocacy Activity Scale (PAAS) [ Time Frame: Change in PAAS score from Baseline to 23 weeks (12 weeks post-tx) ]
    Self-rating of personal advocacy behaviors
  • General Self Efficacy Scale (GSES) [ Time Frame: Change in GSES score from Baseline to 11 weeks (immediately post-tx) ]
    Assesses one's ability to cope with various demands in life
  • General Self Efficacy Scale (GSES) [ Time Frame: Change in GSES score from Baseline to 17 weeks (6 weeks post-tx) ]
    Assesses one's ability to cope with various demands in life
  • General Self Efficacy Scale (GSES) [ Time Frame: Change in GSES score from Baseline to 23 weeks (12 weeks post-tx) ]
    Assesses one's ability to cope with various demands in life
  • Satisfaction With Life Scale (SWLS) [ Time Frame: Change in SWLS score from Baseline to 11 weeks (immediately post-tx) ]
  • Satisfaction With Life Scale (SWLS) [ Time Frame: Change in SWLS score from Baseline to 17 weeks (6 weeks post-tx) ]
  • Satisfaction With Life Scale (SWLS) [ Time Frame: Change in SWLS score from Baseline to 23 weeks (12 weeks post-tx) ]
  • Flourishing Scale (FS) [ Time Frame: Change in FS score from Baseline to 11 weeks (immediately post-tx) ]
    Measures self-perceived success in relationships, self-esteem, and purpose in life
  • Flourishing Scale (FS) [ Time Frame: Change in FS score from Baseline to 17 weeks (6 weeks post-tx) ]
    Measures self-perceived success in relationships, self-esteem, and purpose in life
  • Flourishing Scale (FS) [ Time Frame: Change in FS score from Baseline to 23 weeks (12 weeks post-tx) ]
    Measures self-perceived success in relationships, self-esteem, and purpose in life
  • Participation Assessment with Recombined Tools-Objective (PART-O) [ Time Frame: Change in PART-O score from Baseline to 11 weeks (immediately post-tx) ]
    Objective measure of participation in society
  • Participation Assessment with Recombined Tools-Objective (PART-O) [ Time Frame: Change in PART-O score from Baseline to 17 weeks (6 weeks post-tx) ]
    Objective measure of participation in society
  • Participation Assessment with Recombined Tools-Objective (PART-O) [ Time Frame: Change in PART-O score from Baseline to 23 weeks (12 weeks post-tx) ]
    Objective measure of participation in society
Not Provided
Not Provided
 
Self-Advocacy for Independent Life (SAIL) After TBI
Self-Advocacy for Independent Life (SAIL) After Traumatic Brain Injury
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
TBI (Traumatic Brain Injury)
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.
  • Experimental: 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.
    Intervention: Behavioral: Self-Advocacy for Independent Life (SAIL)
  • No Intervention: Control
    SAIL workbook provided at the conclusion of the study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
74
Same as current
January 31, 2020
January 31, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Clare Morey, MA 303-789-8621 cmorey@craighospital.org
Contact: Lenore Hawley, MSSW 303-789-8570 lhawley@craighospital.org
United States
 
 
NCT03385824
NIDILRR SAIL 2017
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Lenore Hawley, Craig Hospital
Craig Hospital
Not Provided
Not Provided
Craig Hospital
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP