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

Sponsor
Florida State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05936255
Collaborator
National Cancer Institute (NCI) (NIH)
10
1
1
12
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Give to Others Module
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Examination of a Telehealth, Cognitive-behavioral Therapy for Adolescents
Actual Study Start Date :
Apr 17, 2023
Anticipated Primary Completion Date :
Mar 17, 2024
Anticipated Study Completion Date :
Apr 17, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Give to Others Module

A brief, talk therapy protocol that targets negative interpersonal beliefs (i.e., perceived social disconnection, burdensomeness) using cognitive-behavioral strategies.

Behavioral: Give to Others Module
Negative interpersonal beliefs are targeted via cognitive-behavioral strategies, including evaluation of cognitive distortions, and activity planning and tracking.

Outcome Measures

Primary Outcome Measures

  1. Qualitative interview on acceptability [Posttreatment assessment (week 6)]

    Non-numerical identification of narrative textual themes from interviews.

  2. Interpersonal needs questionnaire [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Florida State University Tallahassee Florida United States 32306

Sponsors and Collaborators

  • Florida State University
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Victor Buitron, PhD, Florida State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Victor Buitron, Principal Investigator, Florida State University
ClinicalTrials.gov Identifier:
NCT05936255
Other Study ID Numbers:
  • STUDY00003755
  • U54CA267730
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 7, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 7, 2023