Targeting Burdensomeness Among Clinic Referred Youth

Florida International University (FIU)

Status: Completed

Conditions: Perceived Burdensomeness Toward Others

Treatments: Behavioral: GIVE Module

Study type: Interventional

Funder types: Other

Identifiers

NCT03781037

1F31MH116603

Details and patient eligibility

About

This study will develop and pilot test a novel intervention module targeting perceived burdensomeness toward others in 30 clinic referred youths who experience anxiety or depression and elevated levels of burdensomeness. All participants will be assigned to receive the intervention in this open trial.

Full description

Suicidal ideation is prevalent and impairing in youth, with approximately 15% of high school students reporting seriously considering a suicide attempt and making a specific plan for suicide in the past 12 months. Substantial evidence documents perceived burdensomeness towards others, or the belief that one is a burden or drain on others, as a risk factor for suicide ideation in youth. This evidence highlights the potential promise of perceived burdensomeness as a novel intervention target to prevent suicide ideation in youth. The current study will develop and preliminary evaluate a novel, brief behavioral treatment module targeting perceived burdensomeness in youth that can be embedded within existing psychosocial treatments. The study will use an open trial design. The first aim of this proposal is to develop a novel, brief psychosocial intervention module (the GIVE module) targeting perceived burdensomeness towards others that can be embedded within existing CBT protocols for youth internalizing problems. The second aim is to collect data relevant to client satisfaction and reductions in perceived burdensomeness. Participants will be N=30 clinic-referred youth ages 10 to 17 years with anxiety or depressive disorders in a university-based research clinic, who display elevated levels of perceived burdensomeness. In the context on ongoing CBT for anxiety or depression, participants will complete the GIVE module at sessions 6 and 7 of the CBT protocol. It is hypothesized that perceived burdensomeness will be significantly lower after the GIVE module is administered, and that client satisfaction will be high. Data collected in this study will provide the foundation for a subsequent randomized controlled trial of the GIVE module.

Enrollment: 18 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of an anxiety disorder, persistent depressive disorder, or major depressive disorder
• Score > 4 on the youth self-report Interpersonal Needs Questionnaire- Perceived Burdensomeness Scale

Exclusion criteria

• Clinical diagnosis of a Psychotic Disorder, Autism Spectrum Disorder or Intellectual Disability
• Show high risk of imminent self-injurious behaviors
• Be involved currently in another behavioral treatment
• Not live with a primary caregiver who is legally able to give consent for the youth's participation
• Be a victim of previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Children and Families.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

GIVE module

Experimental group

Description:

The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression. The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.

Treatment:

Behavioral: GIVE Module