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

Not Applicable

Recruiting

• Conditions: Self Injurious Behavior; Suicide

• Registration Number: NCT06720753
• Lead Sponsor: University of Utah

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:
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Detailed Description

Suicide marks an extreme along a continuum of self-inflicted injury (SII) and is a leading cause of death among adolescents. Although psychologists have evidence-supported interventions for youth SII, the biosocial mechanisms supporting change are underexplored. Lack of innovation in this area has led to statis, rather than decline, in population-level suici...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-07-29
• Study First Submitted: 2024-11-22
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-06
• Last Update Posted: 2024-12-06
• Primary Completion: 2029-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Rates of skill use in daily life as assessed via ecological momentary assessment mobile surveys	Frequency of skills use reported over the course of two 10-day EMA periods immediately post skills training (EMAs are 5 x per day)	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.
Self-injurious urges, behaviors, and suicidal ideation as reported on ecological momentary assessment items	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).	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...
Emotion regulation/dysregulation changes as assessed on the difficulties in emotion regulation scale- short form (DERS-SF)	Patterns and changes in emotion regulation/dysregulation indices will be assessed from Visit 1 through 6-month follow-up (approximately 8 months).	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 sc...
Neural patterns and changes from pre- to post-skills training on fMRI tasks (Opposite action paradigm and EmpaTom-Y)	Visit 1 and post-intervention scan at Visit 3 (taken approximately 5-6 weeks apart.	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 t...
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	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.	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).
Barriers to skill use as self-reported on ecological momentary assessment	Across approximately 2 months	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.

Secondary Outcome Measures

Name	Time	Method
Impact of skills use on life stress as assessed by the Life Events and Difficulties Schedule (LEDS-II)	Approximately 8 months	The investigators hypothesize that skill use during laboratory visits and in daily life (assessed via ecological momentary assessment; EMA) will predict subsequent reductions in life stressors the that are dependent on adolescent characteristics and/or behaviors (assessed by comparing LEDS-II results from baseline to 6-month follow-up).
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	All family discussion tasks will be coded with the SCIFF to examine changes from pre- to post-intervention training.
Examine changes in emotion regulation/dysregulation from pre- to post-intervention discussion tasks via respiratory sinus arrhythmia (RSA)	Across approximately 1 month	RSA will be assessed as a physiological index of emotion regulation across all discussion tasks (both pre- and post-intervention).

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States