Assistive Soft Skills and Employment Training (ASSET) in TBI Injury
Primary Purpose
Traumatic Brain Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Assistive Soft Skills and Employment Training (ASSET)
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria: Age 15-25 At least one year post injury. Exclusion Criteria: any other significant neurological history other than their TBI. unstable or uncontrolled seizures (as defined by an increase in the rate of seizures over the 3 months before study participation)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
Social Skills Questionnaire for Traumatic Brain Injury
This is a 41-tem scale to assess social skills in TBI
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05705817
Brief Title
Assistive Soft Skills and Employment Training (ASSET) in TBI Injury
Official Title
Assistive Soft Skills and Employment Training (ASSET) in Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pediatric traumatic brain injury (TBI) is often associated with difficulties in social functioning. Loss of social contacts and difficulties maintaining social connections is common after pediatric TBI, extending into adulthood. Social skills are a key aspect of social functioning critical to forming and maintaining social relationships with others, including family, friends, teachers and co-workers. Social skills deficits are thus critical to social participation and overall quality of life. The identification of treatment techniques to effectively address these issues are thus of paramount importance. The ability to improve social skills in adolescents and young adults is critical as they transition from school settings into the workforce. Impairments in social skills have been demonstrated to underlie difficulties transitioning from school to work and independent living in students with disabilities. Therefore, targeting social skills interventions as individuals enter adulthood and enter the workforce is likely to improve overall functioning during this transitional period in their lives.
The current study will examine preliminary efficacy of a manualized group intervention that targets social skills, specifically work-related social skills known as soft skills. Targeting not only general social skills, but soft skills in particular, is expected to be particularly useful for teens and young adults as they transition from school into the workforce.
The Assistive Soft Skills and Employment Training (ASSET) is a 15-session training program that combines specific skill training, structured learning, social performance training and a social hour to practice skills through a manualized group intervention. Specific skills taught within the program include communication, attitude and enthusiasm, teamwork, networking, problem-solving and critical thinking, professionalism, mental health and stress management, awareness of self and others, workplace relationships and self-advocacy. ASSET utilizes a manualized curriculum and provides additional support including handouts, PowerPoint summaries, instructional procedures, video models, materials for caregivers, and an online platform to support learning the program. ASSET has been utilized with young adults with ASD with very positive results, improving performance on measures of social skills, social communication, self-confidence/self-efficacy and psychological wellness. The current proposal will test the efficacy of the ASSET program in youth and young adults with TBI between the ages of 15 and 25, a critical time as individuals' transition from school settings into the workforce. The proposal will evaluate the primary outcome of improvements in social skills following completion of the ASSET program. Secondary outcomes of self-efficacy, depression, anxiety and quality of life will also be evaluated following completion of the program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Assistive Soft Skills and Employment Training (ASSET)
Intervention Description
The ASSET program is a 15-session training program that combines specific skill training, structured learning, social performance training and a social hour to practice skills through a manualized group intervention. Specific skills taught within the program include communication, enthusiasm and attitude, teamwork, networking, problem-solving and critical thinking, and professionalism.
Primary Outcome Measure Information:
Title
Social Skills Questionnaire for Traumatic Brain Injury
Description
This is a 41-tem scale to assess social skills in TBI
Time Frame
Within 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 15-25
At least one year post injury.
Exclusion Criteria:
any other significant neurological history other than their TBI.
unstable or uncontrolled seizures (as defined by an increase in the rate of seizures over the 3 months before study participation)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeannie Lengenfelder
Phone
19733248447
Email
jlengenfelder@kesslerfoundation.org
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Moore
Phone
973.324.8450
Email
nbmoore@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannie Lengenfelder
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assistive Soft Skills and Employment Training (ASSET) in TBI Injury
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