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

NCT06720753 | Recruiting DMC

• 1 other identifier: K23MH135225
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Rates of skill use in daily life as assessed via ecological momentary assessment mobile surveys

  The investigators will assess the rate of self-reported skills use across post-skill training EMA periods to understand retention, generalization, and potential decay effects. We will also examine whether rates increase following a brief booster call intended to reiterate the skill to youth participants.

  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

  Change in self-reported rates and intensity of self-inflicted injury urges/behavior and suicidal ideation will be assessed from pre- to post-skills training. We will compare data from baseline interviews/surveys/EMA1 to post-skills training time points (EMA2 and EMA 3) and 6-month follow-up (assessed with the L-SASII). Frequency of self-reported skill use in daily life will be used as a key predictor variable.

  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)

  The investigators will be examining change in self-reported emotion regulation/dysregulation from the pre-intervention discussion task to post-skills training via the difficulties in emotion regulation scale short form (DERS-SF). The answers are assessed using a 5-point Likert scale, from 1 (almost never) to 5 (almost always). It is possible to obtain the score of each of 6 subscales, and the total score of the DERS-SF (18-90), with higher values indicating greater difficulties in emotion regulation.

  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)

  Participants will learn skills in the laboratory environment and implement them in daily life. The investigators will observe change in neural activation in response to skill-targeted probes of empathy and perspective taking and opposite action from pre- to post-training (Visit 1 to Visit 3). Specifically, the investigators expect intervention changes will translate to (1) increased left ventro-lateral prefrontal cortex engagement during an fMRI paradigm tapping opposite action; and (2) increased medial pre-frontal cortex engagement during a task tapping perspective taking and empathy (EmpaTom-Y; corresponding to GIVE).

  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

  The investigators will assess associations between experiences of life stress at baseline (assessed via the LEDS-II interview) and subsequent rates of skill use in daily life (EMA2 and EMA3).

  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

  Participant reported barriers to skill use will be assessed via ecological momentary assessment items. This information will aid us in better optimizing how these skills are taught.

  Across approximately 2 months

Secondary Outcomes (3)

• Impact of skills use on life stress as assessed by the Life Events and Difficulties Schedule (LEDS-II)

  Approximately 8 months

• Changes in family functioning from pre-intervention to post-intervention discussion tasks as assessed via The System for Coding Interactions and Family Functioning (SCIFF)

  Across approximately 4-5 weeks

• Examine changes in emotion regulation/dysregulation from pre- to post-intervention discussion tasks via respiratory sinus arrhythmia (RSA)

  Across approximately 1 month

Study Arms (2)

Opposite action

EXPERIMENTAL

Participants will be randomly assigned to this arm either first or second. All participants complete both arms.

Behavioral: Opposite to emotion action

GIVE

EXPERIMENTAL

Participants will be randomly assigned to this arm either first or second. All participants complete both arms.

Behavioral: GIVE

Interventions

Opposite to emotion action BEHAVIORAL

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

Opposite action

GIVE BEHAVIORAL

Participants will be taught the GIVE skill from Dialectical Behavior Therapy

GIVE

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• + 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

You may not qualify if:

• Moderate to severe developmental or intellectual disability, psychosis, or a schizophrenia spectrum diagnosis.
• Those taking medications with well-documented effects on psychophysiological responding.

Sponsors & Collaborators

• University of Utah: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior; Suicide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Erin Kaufman, Ph.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Kaufman, Ph.D.

CONTACT

8017819433; erin.kaufman@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Research assistants performing behavioral coding will be masked to participant condition.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 6, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: All materials will be shared following analysis and publication of main study questions.
• Access Criteria: All de-identified data and code relevant to the project will be uploaded to OSF

Locations

US (1)