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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
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 9, 2023
    Last Updated
    May 3, 2023
    Sponsor
    Kessler Foundation
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    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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