Real-time Examination of Skills and Coping Use in Teen's Everyday Lives
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-18
SponsorUniversity of Utah
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Moderate to severe developmental or intellectual disability, psychosis, or a schizophrenia spectrum diagnosis.
Those taking medications with well-documented effects on psychophysiological responding.
Trial design
Design model
Crossover
Treatments tested in this trial
Opposite to emotion action
BehavioralParticipants will be taught the opposite action skill from Dialectical Behavior Therapy
GIVE
BehavioralParticipants will be taught the GIVE skill from Dialectical Behavior Therapy
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Opposite actionExperimental treatment 1 intervention
Group B: GIVEExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
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)2
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.
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).3
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.
Time frame
Patterns and changes in emotion regulation/dysregulation indices will be assessed from Visit 1 through 6-month follow-up (approximately 8 months).4
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).
Time frame
Visit 1 and post-intervention scan at Visit 3 (taken approximately 5-6 weeks apart.Secondary outcomes
1
Impact of skills use on life stress as assessed by the Life Events and Difficulties Schedule (LEDS-II)
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).
Time frame
Approximately 8 months2
Changes in family functioning from pre-intervention to post-intervention discussion tasks as assessed via The System for Coding Interactions and Family Functioning (SCIFF)
All family discussion tasks will be coded with the SCIFF to examine changes from pre- to post-intervention training.
Time frame
Across approximately 4-5 weeks3
Examine changes in emotion regulation/dysregulation from pre- to post-intervention discussion tasks via respiratory sinus arrhythmia (RSA)
RSA will be assessed as a physiological index of emotion regulation across all discussion tasks (both pre- and post-intervention).
Time frame
Across approximately 1 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov