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

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.

Study Overview

• Status: Terminated
• Conditions: Suicidal Ideation; Suicide Prevention
• Intervention / Treatment: Behavioral: Give to Others Module

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative interview on acceptability	Non-numerical identification of narrative textual themes from interviews.	Posttreatment assessment (week 6)
Interpersonal needs questionnaire	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.	Pretreatment (baseline) and week 6

Collaborators and Investigators

• Sponsor: Florida State University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Victor Buitron, PhD, Florida State University

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Actual): October 26, 2023
• Study Completion (Actual): October 26, 2023

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide Prevention
• Other Study ID Numbers: STUDY00003755; U54CA267730 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No