Back to resultsPilot Examination of a Telehealth, Cognitive-behavioral Therapy for Adolescents
Primary Purpose
Suicide Prevention, Suicidal Ideation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Give to Others Module
Sponsored by
About this trial
This is an interventional treatment trial for Suicide Prevention
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
Sites / Locations
- Florida State UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Give to Others Module
Arm Description
A brief, talk therapy protocol that targets negative interpersonal beliefs (i.e., perceived social disconnection, burdensomeness) using cognitive-behavioral strategies.
Outcomes
Primary Outcome Measures
Qualitative interview on acceptability
Non-numerical identification of narrative textual themes from interviews.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05936255
First Posted
June 30, 2023
Last Updated
June 30, 2023
Sponsor
Florida State University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT05936255
Brief Title
Pilot Examination of a Telehealth, Cognitive-behavioral Therapy for Adolescents
Official Title
Pilot Examination of a Telehealth, Cognitive-behavioral Therapy for Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
March 17, 2024 (Anticipated)
Study Completion Date
April 17, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Prevention, Suicidal Ideation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Give to Others Module
Arm Type
Experimental
Arm Description
A brief, talk therapy protocol that targets negative interpersonal beliefs (i.e., perceived social disconnection, burdensomeness) using cognitive-behavioral strategies.
Intervention Type
Behavioral
Intervention Name(s)
Give to Others Module
Intervention Description
Negative interpersonal beliefs are targeted via cognitive-behavioral strategies, including evaluation of cognitive distortions, and activity planning and tracking.
Primary Outcome Measure Information:
Title
Qualitative interview on acceptability
Description
Non-numerical identification of narrative textual themes from interviews.
Time Frame
Posttreatment assessment (week 6)
Title
Interpersonal needs questionnaire
Description
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.
Time Frame
Pretreatment (baseline) and week 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Buitron, PhD
Phone
850-794-8002
Email
buitron@psy.fsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Victor Victor, PhD
Phone
PhD
Email
buitron@psy.fsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Buitron, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Buitron, phd
Phone
850-794-8002
Email
BUITRON@psy.fsu.edu
First Name & Middle Initial & Last Name & Degree
Victor Buitron, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Pilot Examination of a Telehealth, Cognitive-behavioral Therapy for Adolescents
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