Therapeutic Evaluative Conditioning to Reduce Adolescents' Self-injurious Thoughts and Behaviors During and After Psychiatric Inpatient Hospitalization
TEC
1 other identifier
interventional
155
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2023
CompletedStudy Start
First participant enrolled
March 31, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
July 12, 2024
July 1, 2024
3.4 years
February 6, 2023
July 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Self-injurious thoughts and behaviors
The investigators will assess the presence and frequency of non-suicidal self-injury, suicidal thoughts, suicide plans, suicide attempts and other suicidal behaviors, such as aborted suicide attempts. The investigators will also assess the severity of suicidal thoughts as well.
During inpatient hospitalization (average 14 days), plus an additional two months post- hospitalization.
Study Arms (2)
Active intervention arm
ACTIVE COMPARATORParticipants will complete the intervention on a mobile device.
Control arm
SHAM COMPARATORParticipants will complete the sham comparator on a mobile device.
Interventions
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").
Match neutral pictures to account for doing an intervention.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Franciscan Hospital For Children, INC.lead
- National Institute of Mental Health (NIMH)collaborator
- Harvard Universitycollaborator
Study Sites (1)
Franciscan Hospital For Children, Inc.
Brighton, Massachusetts, 02135, United States
Related Publications (1)
Franklin JC, Fox KR, Franklin CR, Kleiman EM, Ribeiro JD, Jaroszewski AC, Hooley JM, Nock MK. A brief mobile app reduces nonsuicidal and suicidal self-injury: Evidence from three randomized controlled trials. J Consult Clin Psychol. 2016 Jun;84(6):544-57. doi: 10.1037/ccp0000093. Epub 2016 Mar 28.
PMID: 27018530BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will not know which group they are in but researchers will know.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research
Study Record Dates
First Submitted
February 6, 2023
First Posted
April 3, 2023
Study Start
March 31, 2023
Primary Completion (Estimated)
August 15, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
July 12, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- Twice yearly.
- Access Criteria
- public
In accordance with the guidelines of this funding opportunity announcement (FOA), all data will be shared via the National Database for Clinical Trials related to Mental Illness (NDCT) and the National Institute of Mental Health Data Archive (NDA). Raw (descriptive) data. The investigators will share all baseline data, summaries from behavioral tasks (i.e., Affect Misattribution Procedure) and intervention (Therapeutic Evaluative Conditioning), follow-up data, and real-time monitoring data. These data will be linked by Globally Unique Identifier (GUID) and stored in comma separated variable (CSV) format. A formal "data expected list" will be created within six months of award, as required by the FOA.