Targeting Burdensomeness Among Clinic Referred Youth

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03781037

Enrollment

Registered

2018-12-19

Start date

2019-03-20

Completion date

2020-12-30

Last updated

2021-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perceived Burdensomeness Toward Others

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.

Interventions

BEHAVIORALGIVE 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

open label pilot study

Eligibility

Sex/Gender

ALL

Age

10 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire	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).

Secondary

Measure	Time frame	Description
10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory	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).
41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders	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).
41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders	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).
10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory	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).
17-item Parent Rated Children's Depression Inventory - 2	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.
8-item Youth Rated Client Satisfaction Questionnaire	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).
8-item Parent Rated Client Satisfaction Questionnaire	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.
28-item Youth-rated Children's Depression Inventory - 2	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	18
Total	18

Baseline characteristics

Characteristic	GIVE Module
Age, Customized Between 10 and 17 years	18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	1 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	16 Participants
Region of Enrollment United States	18 Participants
Sex: Female, Male Female	15 Participants
Sex: Female, Male Male	3 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 18
other Total, other adverse events	0 / 18
serious Total, serious adverse events	0 / 18

Outcome results

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).