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OpenTrials
Completed

NCT Number: NCT03781037

Targeting Burdensomeness Among Clinic Referred Youth

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.

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Key information

Conditions

Perceived Burdensomeness Toward Others

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida International University Center for Children and Families

Miami, Florida, 33199, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

    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).

  2. 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)

    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).

  3. 41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders

    Time frame: 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).

  4. 41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders

    Time frame: 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).

  5. 28-item Youth-rated Children's Depression Inventory - 2

    Time frame: 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.

  6. 17-item Parent Rated Children's Depression Inventory - 2

    Time frame: 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.

  7. 8-item Youth Rated Client Satisfaction Questionnaire

    Time frame: 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. 8-item Parent Rated Client Satisfaction Questionnaire

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 19, 2018
Registry last updated
Jun 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.