Real-time Examination of Skills and Coping Use in Teen's Everyday Lives

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT06720753
Status
Recruiting
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Conditions

  • Self Injurious Behavior
  • Suicide

Eligibility Criteria

Sex
ALL
Age
13 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Opposite to emotion action — BEHAVIORAL
    Participants will be taught the opposite action skill from Dialectical Behavior Therapy
  • GIVE — BEHAVIORAL
    Participants will be taught the GIVE skill from Dialectical Behavior Therapy

Study Details

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.

Key Dates

Start date
Jul 29, 2024
Status verified
Jan 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Opposite action
    Participants will be randomly assigned to this arm either first or second. All participants complete both arms.
  • Experimental: GIVE
    Participants will be randomly assigned to this arm either first or second. All participants complete both arms.

Primary Outcome Measure

Rates of skill use in daily life as assessed via ecological momentary assessment mobile surveys [ Time Frame: Frequency of skills use reported over the course of two 10-day EMA periods immediately post skills training (EMAs are 5 x per day) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of UtahSalt Lake CityUtah84108
Mark Weiss
[email protected]
801-646-6191

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By research site
University of Utah· Salt Lake City, UT

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