Perceived Burdensomeness Toward OthersNCT03781037
Targeting Burdensomeness Among Clinic Referred Youth
A study testing GIVE Module in people with Perceived Burdensomeness Toward Others, run by Florida International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Perceived Burdensomeness Toward Others
- What is being tested?
- GIVE Module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2019to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida International University Center for Children and Families
Miami, Florida, 33199
About this study
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.
Read the 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.
- Conditions
- Perceived Burdensomeness Toward Others
- Being tested
- GIVE Module
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIVE ModuleBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: GIVE Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: post-intervention (within one week of completing the GIVE Module)
Secondary outcomes (8)
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).
Measured: post-intervention (within one week of completing the GIVE Module)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: post-intervention (within one week of completing the GIVE Module)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start20 Mar 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perceived Burdensomeness Toward OthersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open label pilot study
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781037
- Sponsor's protocol ID
- 1F31MH116603
- Status last verified
- May 2021
- First submitted
- 18 Dec 2018
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Burdensomeness Among Clinic Referred Youth
- ClinicalTrials.gov ID
- NCT03781037
- Acronym / sponsor ID
- 1F31MH116603
- Conditions
- Perceived Burdensomeness Toward Others
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 8 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open label pilot study
| Arm | Type | Receives |
|---|---|---|
| GIVE module | Experimental | Behavioral: GIVE ModuleThe 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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIVE ModuleThe 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. | Behavioural | GIVE module |
Primary outcome
6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire
Time frame: 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).
8 secondary outcomes
10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory
Time frame: post-intervention (within one week of completing the GIVE Module)
10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory
Time frame: post-intervention (within one week of completing the GIVE Module)
41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders
Time frame: post-intervention (within one week of completing the GIVE Module)
41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders
Time frame: post-intervention (within one week of completing the GIVE Module)
28-item Youth-rated Children's Depression Inventory - 2
Time frame: post-intervention (within one week of completing the GIVE Module)
17-item Parent Rated Children's Depression Inventory - 2
Time frame: post-intervention (within one week of completing the GIVE Module)
8-item Youth Rated Client Satisfaction Questionnaire
Time frame: post-intervention (within one week of completing the GIVE Module)
8-item Parent Rated Client Satisfaction Questionnaire
Time frame: post-intervention (within one week of completing the GIVE Module)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIVE Module in people with Perceived Burdensomeness Toward Others, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire (time frame: post-intervention (within one week of completing the GIVE Module)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2021.