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Clinical Trials/NCT05936255
NCT05936255
Terminated
Not Applicable

Pilot Examination of a Telehealth, Cognitive-behavioral Therapy for Adolescents

Florida State University1 site in 1 country5 target enrollmentApril 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide Prevention
Sponsor
Florida State University
Enrollment
5
Locations
1
Primary Endpoint
Qualitative interview on acceptability
Status
Terminated
Last Updated
2 years ago

Overview

Brief Summary

This project is designed to refine a 6-week telehealth therapy intervention targeting negative interpersonal beliefs among community-dwelling youth with elevated levels of psychopathology. The study design is a single-arm open trial. The intervention is comprised of weekly teen and parent group cognitive-behavioral therapy, regular check-ins with the youths, and a module embedded throughout treatment that targets negative interpersonal beliefs (i.e., perceived social disconnection, burdensomeness). The goal of the study is to evaluate the feasibility of the treatment and assessment protocol, refine the intervention based on qualitative feedback, and evaluate changes in negative interpersonal beliefs. Youths complete two qualitative interviews about their interpersonal relationships and their feedback about the intervention.

Registry
clinicaltrials.gov
Start Date
April 17, 2023
End Date
October 26, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Victor Buitron

Principal Investigator

Florida State University

Eligibility Criteria

Inclusion Criteria

  • 14-17 years of age
  • endorsement of perceived burdensomeness (score of greater than 3 on the Interpersonal Needs Questionnaire)
  • emotional/behavioral problems broadly defined (Pediatric Symptom Checklist score greater than 14)
  • The family being under-resourced (i.e., family is below the US census poverty line; family is receiving economic or medical government aid; child is receiving reduced fee lunch; or primary caregiver is currently unemployed) or living in an under-resourced community (i.e., majority of households in the family's census block lives under the poverty line).

Exclusion Criteria

  • Current need for acute psychiatric care (e.g., inpatient hospitalization)
  • autism spectrum disorder
  • psychosis
  • other condition(s) related to pronounced cognitive impairment (i.e., marked impairment that precludes completion of questionnaires, verbal communication)
  • Wards of the state

Outcomes

Primary Outcomes

Qualitative interview on acceptability

Time Frame: Posttreatment assessment (week 6)

Non-numerical identification of narrative textual themes from interviews.

Interpersonal needs questionnaire

Time Frame: Pretreatment (baseline) and week 6

A 6 question survey assessing thoughts of being a burden on others. Range of possible scores is 6 to 42. Higher scores indicate more severe thoughts of being a burden on others.

Study Sites (1)

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