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

NCT05936255 | Terminated

• 2 other identifiers: STUDY00003755U54CA267730
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide Prevention; Suicidal Ideation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Give to Others Module

EXPERIMENTAL

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

Interventions

Give to Others Module BEHAVIORAL

Negative interpersonal beliefs are targeted via cognitive-behavioral strategies, including evaluation of cognitive distortions, and activity planning and tracking.

Give to Others Module

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Suicide Prevention; Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Victor Buitron, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 7, 2023
• Study Start: April 17, 2023
• Primary Completion: October 26, 2023
• Study Completion: October 26, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

US (1)