Recruiting

Therapeutic Evaluative Conditioning

Sponsor:

Franciscan Hospital For Children, INC.

Code:

NCT05796531

Conditions

Self-Injurious Behavior

Suicidal Ideation

Suicide Attempts

Eligibility Criteria

Sex: All

Age: 12 - 19

Healthy Volunteers: Not accepted

Interventions

Therapeutic Evaluative Conditioning

Neutral comparison condition

Study Details

Brief summary:

Suicide is the 2nd leading cause of death among adolescents, with the highest risk period for suicide being the month following psychiatric inpatient hospitalization. The investigators propose testing a brief, scalable intervention using evaluative conditioning aimed at reducing suicidal thoughts and behaviors among adolescents during and after inpatient hospitalization. Scalable interventions, such as the one proposed that reduce suicide risk during this markedly high-risk period, could result in large-scale decreases in suicide death.

Conditions

Self-Injurious Behavior

Suicidal Ideation

Suicide Attempts

Study ID

NCT05796531

Start date

Mar 31, 2023

Status verified date

Jul, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Be a patient on McLean-Franciscan Child and Adolescent Inpatient Program (MF-CAIP) of Franciscan Children's (FC)
  • Be 12-19 years-old
  • Own a smartphone
  • Have a parent/guardian that can provide permission
  • Child can assent
  • Presentation to the hospital with non-suicidal self-injury (NSSI), suicidal ideation or a suicide attempt.

Exclusion Criteria:

  • Any factor that impairs an individual's ability to comprehend and effectively participate in the study, including
  • an inability to speak or write English fluently
  • the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, etc., or the presence of extremely agitated or violent behavior
  • a potential discharge location anticipated to be a residential program in which the average length of stay is more than 14 days

Study Design

Enrollment

155 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active intervention arm

Participants will complete the intervention on a mobile device.

sham comparator: Control arm

Participants will complete the sham comparator on a mobile device.

Interventions

Therapeutic Evaluative Conditioning

Participants are told which pictures are "matched pairs." They find the "matched pairs" among 4 or 8 pictures. By associating pictures and words associated with SITB (e.g., pictures of cut skin, pictures of people engaging in potentially suicidal behaviors, and the word "death") with naturally aversive images (e.g., snakes and spiders), it increases the aversion to SITB. The second goal is to increase liking toward the self by pairing self-relevant stimuli (e.g., the participant's name or other self-relevant details, as well as words like "I" and "me").

Neutral comparison condition

Match neutral pictures to account for doing an intervention.

Primary outcome measure

  • Self-injurious thoughts and behaviors [ Time Frame: During inpatient hospitalization (average 14 days), plus an additional two months post- hospitalization. ]

Central Contacts and Locations

Central contacts

Kelly Zuromski, PhD

617-475-0595kzuromski@franciscanchildrens.org

Locations

Franciscan Hospital For Children, Inc.

Recruiting

Brighton, Massachusetts, United States, 02135

Contacts

Jane O'Brien, M.D.

617-779-5811JOBrien@franciscanchildrens.org

Ralph Buonopane, Ph.D.

617-779-1689RBuonopane@franciscanchildrens.org

More Information

Sponsor

Franciscan Hospital For Children, INC.

Last update posted

Jul 12, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Franciscan Hospital For Children, INC. on 2024-07-12.