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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIVE module | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GIVE Module | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida International University Center for Children and Families | Miami | Florida | 33199 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Give Module | All participants were assigned to the Give Module, consisting 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | GIVE Module | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | score on a scale | post-intervention (within one week of completing the GIVE Module) |
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through study completion, up to 14 weeks for each participant
This intervention conferred minimal risk to participants. All participants were young (10 to 17 years) and and no study procedures put participants at risk for serious adverse events, mortality, or other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Give Module | All participants were assigned to the Give Module, consisting 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeremy Pettit | Florida International University | 305-348-1671 | jpettit@fiu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2020 | May 11, 2021 | Prot_SAP_000.pdf |
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open label pilot study
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| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Participants |
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| Participants |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | post-intervention (within one week of completing the GIVE Module) |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | post-intervention (within one week of completing the GIVE Module) |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | post-intervention (within one week of completing the GIVE Module) |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | post-intervention (within one week of completing the GIVE Module) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | post-intervention (within one week of completing the GIVE Module) |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | post-intervention (within one week of completing the GIVE Module) |
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| 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). | Posted | Mean | Standard Deviation | score on a scale | post-intervention (within one week of completing the GIVE Module) |
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| 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. | Not Posted | post-intervention (within one week of completing the GIVE Module) | Participants |
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| 18 |
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