Trial Outcomes & Findings for Targeting Burdensomeness Among Clinic Referred Youth (NCT NCT03781037)
NCT ID: NCT03781037
Last Updated: 2021-06-08
Results Overview
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).
COMPLETED
NA
18 participants
post-intervention (within one week of completing the GIVE Module)
2021-06-08
Participant Flow
Participant milestones
| Measure |
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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Overall Study
STARTED
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18
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Overall Study
COMPLETED
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18
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting Burdensomeness Among Clinic Referred Youth
Baseline characteristics by cohort
| Measure |
GIVE Module
n=18 Participants
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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Age, Customized
Between 10 and 17 years
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18 Participants
n=5 Participants
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Sex: Female, Male
Female
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15 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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15 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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1 Participants
n=5 Participants
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Race (NIH/OMB)
White
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16 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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18 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: post-intervention (within one week of completing the GIVE Module)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).
Outcome measures
| Measure |
Give Module
n=18 Participants
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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6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire
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9.0 score on a scale
Standard Deviation 9.2
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SECONDARY outcome
Timeframe: post-intervention (within one week of completing the GIVE Module)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).
Outcome measures
| Measure |
Give Module
n=18 Participants
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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|---|---|
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10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory
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13.00 score on a scale
Standard Deviation 4.06
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SECONDARY outcome
Timeframe: post-intervention (within one week of completing the GIVE Module)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).
Outcome measures
| Measure |
Give Module
n=18 Participants
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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|---|---|
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10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory
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16.8 score on a scale
Standard Deviation 2.8
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SECONDARY outcome
Timeframe: post-intervention (within one week of completing the GIVE Module)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).
Outcome measures
| Measure |
Give Module
n=18 Participants
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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41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders
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43.27 score on a scale
Standard Deviation 13.94
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SECONDARY outcome
Timeframe: post-intervention (within one week of completing the GIVE Module)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).
Outcome measures
| Measure |
Give Module
n=18 Participants
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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41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders
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30.6 score on a scale
Standard Deviation 14.43
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SECONDARY outcome
Timeframe: post-intervention (within one week of completing the GIVE Module)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.
Outcome measures
| Measure |
Give Module
n=18 Participants
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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28-item Youth-rated Children's Depression Inventory - 2
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18.3 score on a scale
Standard Deviation 9.6
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SECONDARY outcome
Timeframe: post-intervention (within one week of completing the GIVE Module)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.
Outcome measures
| Measure |
Give Module
n=18 Participants
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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17-item Parent Rated Children's Depression Inventory - 2
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15.9 score on a scale
Standard Deviation 8.7
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SECONDARY outcome
Timeframe: post-intervention (within one week of completing the GIVE Module)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).
Outcome measures
| Measure |
Give Module
n=18 Participants
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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|---|---|
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8-item Youth Rated Client Satisfaction Questionnaire
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28.27 score on a scale
Standard Deviation 2.37
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SECONDARY outcome
Timeframe: post-intervention (within one week of completing the GIVE Module)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.
Outcome measures
Outcome data not reported
Adverse Events
Give Module
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place