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

NCT ID: NCT05936255

Last Updated: 2023-10-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2023-10-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Give to Others Module

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

Group Type: EXPERIMENTAL

Give to Others Module

Intervention Type: BEHAVIORAL

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

Interventions

Give to Others Module

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Victor Buitron

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor Buitron, PhD

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Florida State University

Tallahassee, Florida, United States

Countries

United States

Other Identifiers

U54CA267730

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003755

Identifier Type: -

Identifier Source: org_study_id