N/A
N=18
Targeting Burdensomeness Among Clinic Referred Youth
Perceived Burdensomeness Toward Others
Bottom Line
View on ClinicalTrials.gov: NCT03781037 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: 6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire — 9.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GIVE Module (Behavioral)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- Florida International University
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire |
9.0 | — |
| SECONDARY 10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory |
13.00 | — |
| SECONDARY 10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory |
16.8 | — |
| SECONDARY 41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders |
43.27 | — |
| SECONDARY 41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders |
30.6 | — |
| SECONDARY 28-item Youth-rated Children's Depression Inventory - 2 |
18.3 | — |
| SECONDARY 17-item Parent Rated Children's Depression Inventory - 2 |
15.9 | — |
| SECONDARY 8-item Youth Rated Client Satisfaction Questionnaire |
28.27 | — |
| SECONDARY 8-item Parent Rated Client Satisfaction Questionnaire |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03781037). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.