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

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05936255
• Other study ID #: STUDY00003755
• Secondary ID: U54CA267730
• Status: Terminated
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: October 26, 2023

Study information

• Verified date: October 2023
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 26, 2023
• Est. primary completion date: October 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide Prevention

Intervention

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

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Florida State University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative interview on acceptability	Non-numerical identification of narrative textual themes from interviews.	Posttreatment assessment (week 6)
Primary	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