NCT06720753 Real-time Examination of Skills and Coping Use in Teen's Everyday Lives
| NCT ID | NCT06720753 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Self Injurious Behavior |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-07-29 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2024-07-29 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare two core intervention skills among adolescents with a history of engaging in at least 3 lifetime incidents of self-inflicted injury (SII), at least one of which was a suicide attempt of at least moderate lethality and moderate intent to die. The main questions it aims to answer are: Whether and when youth use skills in daily life, how quickly skill use declines after teaching, and whether exposure to life stress influences skill learning and retention. The Investigators also want to know whether brain-related, family-related, and physiology-related factors influence skills practice and any associated changes in self-harm/suicide risk and emotion dysregulation. Participants will complete surveys 5 times a day on their phones at baseline, and following each skill learning session. All participants will learn and practice the two skills with a parent while discussing topics they often argue about. During these discussions, participants will be hooked up to psychophysiological equipment to measure their cardiovascular functioning and their palm sweat. Participants' discussions will be coded for skill use and also for indices of family functioning. Approximately half of the participants will undergo two sets of fMRI scans to assess potential neural underpinnings of skill use.
Eligibility Criteria
Inclusion Criteria: * 3+ incidents of self-inflicted injury (SII). At least one SII episode must score a minimum of "3" on lethality (moderate; e.g., overdose on 11-50 pills; deep cuts anywhere but neck) and "4" on intent (somewhat serious \[about dying\]) - even if aborted or interrupted. Adolescents with 3+ SIIs may also enroll if they have been hospitalized for suicide preparatory behavior. * English language proficiency * Access to a smart phone * Parent/caregiver/legal guardian to participate with the adolescent Exclusion Criteria: * Moderate to severe developmental or intellectual disability, psychosis, or a schizophrenia spectrum diagnosis. * Those taking medications with well-documented effects on psychophysiological responding.
Contact & Investigator
Erin Kaufman, Ph.D.
PRINCIPAL INVESTIGATOR
University of Utah
Frequently Asked Questions
Who can join the NCT06720753 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying Self Injurious Behavior. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06720753 currently recruiting?
Yes, NCT06720753 is actively recruiting participants. Contact the research team at erin.kaufman@utah.edu for enrollment information.
Where is the NCT06720753 trial being conducted?
This trial is being conducted at Salt Lake City, United States.
Who is sponsoring the NCT06720753 clinical trial?
NCT06720753 is sponsored by University of Utah. The principal investigator is Erin Kaufman, Ph.D. at University of Utah. The trial plans to enroll 200 participants.