Targeting Burdensomeness Among Clinic Referred Youth

Perceived Burdensomeness Toward Others Clinical Trial

Official title:

Targeting Burdensomeness Among Clinic Referred Youth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781037
• Other study ID #: 1F31MH116603
• Status: Completed
• Phase: N/A
• Start date: March 20, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: May 2021
• Source: Florida International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Perceived Burdensomeness Toward Others

Intervention

Behavioral:
• GIVE Module
The GIVE Module is a brief cognitive behavioral intervention targeting youths' beliefs that they are a burden or drain on others. It consists of two sessions embedded within a larger CBT protocol for anxiety or depression.

Locations

Country	Name	City	State
United States	Florida International University Center for Children and Families	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida International University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire	Youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 6 and 42. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).	post-intervention (within one week of completing the GIVE Module)
Secondary	10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory	Youth ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like parent; 3 = a lot like parent), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).	post-intervention (within one week of completing the GIVE Module)
Secondary	10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory	Parent self-ratings on parental warmth over the past week. Each of 10 items is scored 1-3 (1 = not like me; 3 = a lot like me), yielding a total score of 10 to 30. Higher scores indicate higher levels of parental warmth (better outcome).	post-intervention (within one week of completing the GIVE Module)
Secondary	41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders	Youth self-ratings on anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).	post-intervention (within one week of completing the GIVE Module)
Secondary	41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders	Parent ratings on youth anxiety symptom severity. Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82. Higher scores indicate higher levels of anxiety (worse outcome).	post-intervention (within one week of completing the GIVE Module)
Secondary	28-item Youth-rated Children's Depression Inventory - 2	Youth self-ratings on depressive symptom severity. Each item is scored 0-2, yielding total scores of 0 to 56, with higher scores corresponding to more severe symptoms.	post-intervention (within one week of completing the GIVE Module)
Secondary	17-item Parent Rated Children's Depression Inventory - 2	Parent ratings on youth depressive symptom severity. Each item is scored 0-3, yielding total scores of 0 to 51, with higher scores corresponding to more severe symptoms.	post-intervention (within one week of completing the GIVE Module)
Secondary	8-item Youth Rated Client Satisfaction Questionnaire	Youth ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32. Higher scores indicate higher satisfaction (better outcome).	post-intervention (within one week of completing the GIVE Module)
Secondary	8-item Parent Rated Client Satisfaction Questionnaire	Parent ratings of satisfaction with the GIVE module. Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32.	post-intervention (within one week of completing the GIVE Module)