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Traumatic Brain InjuryNCT05705817

Assistive Soft Skills and Employment Training (ASSET) in TBI Injury

A study testing Assistive Soft Skills and Employment Training (ASSET) in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 25 years
Conditions the study is for
Traumatic Brain Injury
What is being tested?
Assistive Soft Skills and Employment Training (ASSET)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
5 Jun 2023to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 15-25
  • At least one year post injury.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting
  • Kessler Foundation

    East Hanover, New Jersey, 07936

    Nancy Moore, 973-324-8450, nbmoore@kesslerfoundation.org

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Assistive Soft Skills and Employment Training (ASSET)
Medical subject headings
Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Assistive Soft Skills and Employment Training (ASSET)Behavioural

    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.

Study groups in NCT05705817
Study groupRoleWhat they receive
TreatmentExperimentalNot described
Receives: Behavioral: Assistive Soft Skills and Employment Training (ASSET)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Social Skills Questionnaire for Traumatic Brain Injury

    This is a 41-tem scale to assess social skills in TBI

    Measured: Within 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2023
  2. Study start5 Jun 2023
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05705817
Sponsor's protocol ID
E-1201-22
Status last verified
Oct 2023
First submitted
9 Jan 2023
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Assistive Soft Skills and Employment Training (ASSET) in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jeannie Lengenfelder (19733248447, jlengenfelder@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Skills Questionnaire for Traumatic Brain Injury (time frame: Within 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.

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