ACTIVE_NOT_RECRUITING

Narrative Discourse Treatment Development

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Discourse impairments are breakdowns in meaningful communication beyond the level of single sentences and have a functional impact on the lives of Veterans with TBI, disrupting return to work, communication re integration, socialization, and quality of life. The few prior attempts to treat discourse impairments have been small case studies and resulted in no change or limited gains. The proposed study evaluates the feasibility of a novel narrative discourse treatment that builds upon these prior attempts by addressing breakdowns in both story content and story organization using a theoretically-driven approach. If feasible, as demonstrated by tolerability and acceptability to participants, and later shown to be effective, the proposed discourse treatment has the potential to improve daily communication, which provides a gateway for Veterans with TBI to increase meaningful participation and improve functioning in major life domains.

Official Title

Remediating Narrative Discourse Impairments in Veterans With TBI: Initial Treatment Development

Quick Facts

Study Start:2023-11-27
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05008419

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Veteran with diagnosis of TBI with mild to moderate functional cognitive impairments
  2. * Self-report of communication difficulty following TBI that interferes with activities
  3. * Can identify a significant other (e.g., spouse, family member, friend) who is able and willing to serve as an informant, who will verify discourse ability pre- and post-treatment
  4. * The informant must be an individual with whom the participant engages in weekly social communication
  5. * Adequate hearing and visual acuity to participate in study procedures
  6. * Those who are willing and able to participate in telehealth sessions must have appropriate equipment and access
  7. * e.g., smartphone, tablet, computer with camera, internet access
  8. * Stable housing
  9. * Participants must have a safe, private and quiet environment in their home to engage in telehealth sessions
  10. * English as a primary language
  1. * Penetrating head injury
  2. * History of or current developmental disability (e.g., dyslexia), psychotic disorder, neurological illness
  3. * e.g., stroke, dementia, Parkinson's disease), aphasia or auditory processing disorder (APD)
  4. * Current (past 30 days) diagnosis of alcohol or substance abuse
  5. * An exception will be made for marijuana as a number of Veterans use marijuana occasionally to manage ailments, such as pain and PTSD
  6. * Marijuana use must not occur regularly or interfere with daily functioning
  7. * Inclusion of Veterans using marijuana aligns with the VA's position that Veterans will not be denied VA benefits because of marijuana use

Contacts and Locations

Principal Investigator

Karen Le, PhD
PRINCIPAL_INVESTIGATOR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Locations (Sites)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Karen Le, PhD, PRINCIPAL_INVESTIGATOR, VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2023-11-27
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • traumatic brain injury
  • neurogenic communication disorders
  • pragmatic communication disorders

Additional Relevant MeSH Terms

  • Traumatic Brain Injury
  • Neurogenic Communication Disorders