Recruiting

Observational Study

Sponsor:

University of Utah

Code:

NCT06720753

Conditions

Self Injurious Behavior

Suicide

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

Interventions

Opposite to emotion action

GIVE

Study Details

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.

Conditions

Self Injurious Behavior

Suicide

Study ID

NCT06720753

Start date

Jul 29, 2024

Status verified date

Jan, 2026

Completion date

Mar 31, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Opposite to emotion action

Participants will be taught the opposite action skill from Dialectical Behavior Therapy

GIVE

Participants will be taught the GIVE skill from Dialectical Behavior Therapy

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) ]
  • Self-injurious urges, behaviors, and suicidal ideation as reported on ecological momentary assessment items [ Time Frame: Changes will be assessed from pre-intervention baseline (Visit 1 and a ten day baseline EMA period [EMA1]) across EMA 2 and 3, and 6-month follow-up (post-intervention). ]
  • Emotion regulation/dysregulation changes as assessed on the difficulties in emotion regulation scale- short form (DERS-SF) [ Time Frame: Patterns and changes in emotion regulation/dysregulation indices will be assessed from Visit 1 through 6-month follow-up (approximately 8 months). ]
  • Neural patterns and changes from pre- to post-skills training on fMRI tasks (Opposite action paradigm and EmpaTom-Y) [ Time Frame: Visit 1 and post-intervention scan at Visit 3 (taken approximately 5-6 weeks apart. ]
  • Impact of life stress (assessed with the Life Events and Difficulties Schedule; LEDS-II) on skill learning and retention as reported on ecological momentary assessment items [ Time Frame: A baseline life stress assessment will be completed at Visit 1 (Life Events and Difficulties Schedule; LEDS-II). Skill learning and retention will be assessed via ecological momentary assessment items assessing skill use for approximately 6 weeks. ]
  • Barriers to skill use as self-reported on ecological momentary assessment [ Time Frame: Across approximately 2 months ]

Central Contacts and Locations

Central contacts

Erin Kaufman, Ph.D.

8017819433erin.kaufman@utah.edu

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Mark Weiss

801-646-6191mark.weiss@osp.utah.edu

More Information

Sponsor

University of Utah

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • Self Injurious Behavior
  • Dialectical Behavior Therapy
  • Therapy mechanisms
  • Suicide
  • Adolescents
  • Families
  • fMRI
  • Psychophysiological measures

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-01-30.