- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05705817
Assistive Soft Skills and Employment Training (ASSET) in TBI Injury
Assistive Soft Skills and Employment Training (ASSET) in Traumatic Brain Injury
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jeannie Lengenfelder
- Phone Number: 19733248447
- Email: jlengenfelder@kesslerfoundation.org
Study Contact Backup
- Name: Nancy Moore
- Phone Number: 973.324.8450
- Email: nbmoore@kesslerfoundation.org
Study Locations
-
-
New Jersey
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East Hanover, New Jersey, United States, 07936
- Recruiting
- Kessler Foundation
-
Contact:
- Nancy Moore
- Phone Number: 973-324-8450
- Email: nbmoore@kesslerfoundation.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Skills Questionnaire for Traumatic Brain Injury
Time Frame: Within 2 weeks
|
This is a 41-tem scale to assess social skills in TBI
|
Within 2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jeannie Lengenfelder, Kessler Foundation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-1201-22
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Assistive Soft Skills and Employment Training (ASSET)
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Florida Gulf Coast UniversityCompletedAutism Spectrum Disorder High-FunctioningUnited States
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Michigan State UniversityIllinois Institute of TechnologyCompletedAutism Spectrum Disorder | Social Skills | Transition | Confidence, SelfUnited States
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Rutgers, The State University of New JerseyRecruitingMental Health Wellness 1 | Occupational Problems | Mental Health Wellness 2United States
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Universitas PadjadjaranCompletedAdolescent Mental Health | Bullying Behavior | Emotional Regulation DifficultiesIndonesia
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Danderyd HospitalUniversity of TsukubaCompletedStroke | Hemiparesis | Gait, Hemiplegic | Ambulation DifficultySweden
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Danderyd HospitalUmeå University; Sahlgrenska University Hospital, Sweden; University of TsukubaTerminatedStroke | Hemiparesis | Ambulation DifficultySweden
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The University of Hong KongNot yet recruitingPsychological Well-being | Caregiver Burden of Caregivers
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University of Sao PauloUnknownSchizophrenia and Disorders With Psychotic FeaturesBrazil
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Istituto Auxologico ItalianoCompletedPsychological StressItaly
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Palo Alto Veterans Institute for ResearchUnited States Department of DefenseUnknownDementia | Alzheimer Disease | Head Injury | TBI | Concussion, Brain | Traumas, BrainUnited States