Clinical trial NCT03781037: Targeting Burdensomeness Among Clinic Referred Youth
Official title: Targeting Burdensomeness Among Clinic Referred Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perceived Burdensomeness Toward Others
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 18
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open label pilot study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire
timeFrame: post-intervention (within one week of completing the GIVE Module)
Secondary outcomes:
measure: 10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory
timeFrame: post-intervention (within one week of completing the GIVE Module)
measure: 10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory
timeFrame: post-intervention (within one week of completing the GIVE Module)
measure: 41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders
timeFrame: post-intervention (within one week of completing the GIVE Module)
measure: 41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders
timeFrame: post-intervention (within one week of completing the GIVE Module)
measure: 28-item Youth-rated Children's Depression Inventory - 2
timeFrame: post-intervention (within one week of completing the GIVE Module)
measure: 17-item Parent Rated Children's Depression Inventory - 2
timeFrame: post-intervention (within one week of completing the GIVE Module)
measure: 8-item Youth Rated Client Satisfaction Questionnaire
timeFrame: post-intervention (within one week of completing the GIVE Module)
measure: 8-item Parent Rated Client Satisfaction Questionnaire
timeFrame: post-intervention (within one week of completing the GIVE Module)
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University Center for Children and Families
state: Florida
Study officials:
References: