Self Injurious BehaviorRESCUENCT06720753
Real-time Examination of Skills and Coping Use in Teen's Everyday Lives
A study testing Opposite to emotion action and GIVE in people with Self Injurious Behavior and Suicide, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Self Injurious Behavior, Suicide
- What is being tested?
- Opposite to emotion action and GIVE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2024to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Moderate to severe developmental or intellectual disability, psychosis, or a schizophrenia spectrum diagnosis.
- Those taking medications with well-documented effects on psychophysiological responding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Mark Weiss, 801-646-6191, mark.weiss@osp.utah.edu
About this study
Official title: Examining Mechanisms of Change in Adolescent Self-Inflicted Injury
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.
Read more
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.
Read the 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 suicide rates. The field also lacks vital data on: if/when adolescents apply therapeutic skills in daily life, the neural and physiological factors influencing skill uptake, and whether such skills are effective in reducing SII and related risk and vulnerability factors.
When identifying key intervention targets, theoretical and empirical work implicate emotion dysregulation and interpersonal stressors in SII etiology and maintenance. Adaptive emotion regulation strategies and strong social ties each reduce the likelihood of suicidal ideation and SII among otherwise vulnerable individuals, and improvements in emotion regulation are associated with SII cessation. Yet, the specific skills and mechanisms promoting self-regulatory improvements are not well understood.
This study is designed to rigorously examine two competing SII intervention mechanisms. The research plan and aims are devoted to identifying youth who may benefit from a brief skill-building intervention and biosocial mechanisms supporting skill acquisition. The investigator use a within-subjects design to directly compare the effects of teaching an intra- vs. interpersonal skill from Dialectical Behavior Therapy (DBT; a widely-used intervention for SII). Adolescents with a history of repeated SII (n = 100) will participate in 4 laboratory visits with a primary caregiver. At Visit 1, participants will complete interviews and questionnaires assessing psychiatric diagnoses, SII, and life stress, and 50 will complete two functional MRI paradigms to tap neural processes underlying perspective taking and empathy, and approach/avoidance. Adolescents will then complete a 2-week EMA protocol (EMA1, Training Aim 2) to measure daily affect, perceived stressors, SII, and suicidal thoughts, pre-intervention. At Visit 2, dyads will be randomly assigned to learn and practice GIVE (interpersonal skills training) or opposite-to-emotion action (OA; intrapersonal skill). The investigator will assess behavioral, affective, and physiological regulatory processes (respiratory sinus arrythmia [RSA]) during two conflict discussions: (1) pre- skills training, and (2) post-training, while dyads use their assigned skill. This laboratory assessment will be followed by a second EMA period (EMA2) to assess skill use and EMA1 variables. Post EMA2, dyads will return for Visit 3 to repeat fMRI assessment before undergoing training in the alternate skill ⎯ followed by another 2-week EMA protocol (EMA3). Finally, participants will complete a remote follow-up visit 6 months post-EMA3, where the investigator will reassess SII, symptom severity, and life stressors as well as barriers to skill use. This study will assess and integrate multimodal responses to core intervention mechanisms in a high-risk sample.
Aim 1: Examine within-person mechanistic (brain, RSA) changes as a function of skills training in the laboratory (Training Aim 1).
H1a: Participants will show less RSA withdrawal during skill-practice relative to a pre-training conflict task. H1b: Such intervention changes will translate to increased left ventro-lateral prefrontal cortex engagement during an fMRI paradigm tapping OA; and increased medial pre-frontal cortex engagement during a task tapping perspective taking and empathy (corresponding to GIVE).
H1c: Compared with the OA condition, GIVE training will result in less RSA withdrawal during skills practice.
H1d: The investigator will test whether skill practice effects (H1a, b) are moderated by recent life stressors (Training Aim 3) and expect severe stressors in the 6 months preceding study participation will be associated with less improvement during skills practice across outcome measures.
Aim 2: Examine the effects of skills training on outcomes relevant to suicide risk in daily life.
H2a: Changes observed post-skills training in the GIVE and OA conditions will extend into social and affective improvements in participants' daily lives as reported via EMA - especially in the context of momentary skills use.
H2b: Further, the investigator hypothesize that skill use during laboratory visits and EMA will predict subsequent reductions in life stressors that are dependent on adolescent characteristics and/or behaviors.
Aim 3: Examine persistence/decay effects of skill in daily life following initial skill exposure and a "booster" call.
H3a: Skill use will be most frequent immediately following training and decline over time. H3b: A brief booster call 1 week post-skill exposure will predict increases in EMA reported skill use. The investigator will examine potential moderation effects to determine who may benefit from repeated skill exposure.
H3c: Youth skill use over the EMA period will predict changes in stressor severity experienced over 6-month followup. Specifically, GIVE use will predict less severe dependent stress.
- Conditions
- Self Injurious Behavior, Suicide
- Being tested
- Opposite to emotion action, GIVE
- Keywords
- Self Injurious Behavior, Dialectical Behavior Therapy, Therapy mechanisms, Suicide, Adolescents, Families, fMRI, Psychophysiological measures
- Medical subject headings
- Self-Injurious Behavior, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opposite to emotion actionBehavioural
Participants will be taught the opposite action skill from Dialectical Behavior Therapy
GIVEBehavioural
Participants will be taught the GIVE skill from Dialectical Behavior Therapy
| Study group | Role | What they receive |
|---|---|---|
| Opposite action | Experimental | Participants will be randomly assigned to this arm either first or second. All participants complete both arms. Receives: Behavioral: Opposite to emotion action |
| GIVE | Experimental | Participants will be randomly assigned to this arm either first or second. All participants complete both arms. Receives: Behavioral: GIVE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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)
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).
Measured: 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)
All family discussion tasks will be coded with the SCIFF to examine changes from pre- to post-intervention training.
Measured: Across approximately 4-5 weeks
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).
Measured: Across approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start29 Jul 2024
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self Injurious BehaviorStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Erin Kaufman, University of Utah
- Investigators
- Erin Kaufman, Ph.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720753
- Sponsor's protocol ID
- K23MH135225
- Acronym
- RESCUE
- Status last verified
- Jan 2026
- First submitted
- 22 Nov 2024
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will post descriptions of study methods (including Dialectical Behavior Therapy Skills videos) and procedures to our Open Science Framework (OSF) page. All de-identified data and code relevant to the project will be uploaded to OSF upon submission to encourage replications and extensions of our work. In addition to the data for neuroimaging and RDoC domains, demographic and clinical information will be included. Data collected for exploratory aims will be uploaded upon completion of publication and all relevant reports and publications will be made available per the open access policy of NIH.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Mechanisms of Change in Adolescent Self-Inflicted Injury
- ClinicalTrials.gov ID
- NCT06720753
- Acronym / sponsor ID
- RESCUE / K23MH135225
- Conditions
- Self Injurious Behavior, Suicide
- Keywords
- Self Injurious Behavior, Dialectical Behavior Therapy, Therapy mechanisms, Suicide, Adolescents, Families, fMRI, Psychophysiological measures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Study start
- 29 Jul 2024 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 suicide rates. The field also lacks vital data on: if/when adolescents apply therapeutic skills in daily life, the neural and physiological factors influencing skill uptake, and whether such skills are effective in reducing SII and related risk and vulnerability factors.
When identifying key intervention targets, theoretical and empirical work implicate emotion dysregulation and interpersonal stressors in SII etiology and maintenance. Adaptive emotion regulation strategies and strong social ties each reduce the likelihood of suicidal ideation and SII among otherwise vulnerable individuals, and improvements in emotion regulation are associated with SII cessation. Yet, the specific skills and mechanisms promoting self-regulatory improvements are not well understood.
This study is designed to rigorously examine two competing SII intervention mechanisms. The research plan and aims are devoted to identifying youth who may benefit from a brief skill-building intervention and biosocial mechanisms supporting skill acquisition. The investigator use a within-subjects design to directly compare the effects of teaching an intra- vs. interpersonal skill from Dialectical Behavior Therapy (DBT; a widely-used intervention for SII). Adolescents with a history of repeated SII (n = 100) will participate in 4 laboratory visits with a primary caregiver. At Visit 1, participants will complete interviews and questionnaires assessing psychiatric diagnoses, SII, and life stress, and 50 will complete two functional MRI paradigms to tap neural processes underlying perspective taking and empathy, and approach/avoidance. Adolescents will then complete a 2-week EMA protocol (EMA1, Training Aim 2) to measure daily affect, perceived stressors, SII, and suicidal thoughts, pre-intervention. At Visit 2, dyads will be randomly assigned to learn and practice GIVE (interpersonal skills training) or opposite-to-emotion action (OA; intrapersonal skill). The investigator will assess behavioral, affective, and physiological regulatory processes (respiratory sinus arrythmia [RSA]) during two conflict discussions: (1) pre- skills training, and (2) post-training, while dyads use their assigned skill. This laboratory assessment will be followed by a second EMA period (EMA2) to assess skill use and EMA1 variables. Post EMA2, dyads will return for Visit 3 to repeat fMRI assessment before undergoing training in the alternate skill ⎯ followed by another 2-week EMA protocol (EMA3). Finally, participants will complete a remote follow-up visit 6 months post-EMA3, where the investigator will reassess SII, symptom severity, and life stressors as well as barriers to skill use. This study will assess and integrate multimodal responses to core intervention mechanisms in a high-risk sample.
Aim 1: Examine within-person mechanistic (brain, RSA) changes as a function of skills training in the laboratory (Training Aim 1).
H1a: Participants will show less RSA withdrawal during skill-practice relative to a pre-training conflict task. H1b: Such intervention changes will translate to increased left ventro-lateral prefrontal cortex engagement during an fMRI paradigm tapping OA; and increased medial pre-frontal cortex engagement during a task tapping perspective taking and empathy (corresponding to GIVE).
H1c: Compared with the OA condition, GIVE training will result in less RSA withdrawal during skills practice.
H1d: The investigator will test whether skill practice effects (H1a, b) are moderated by recent life stressors (Training Aim 3) and expect severe stressors in the 6 months preceding study participation will be associated with less improvement during skills practice across outcome measures.
Aim 2: Examine the effects of skills training on outcomes relevant to suicide risk in daily life.
H2a: Changes observed post-skills training in the GIVE and OA conditions will extend into social and affective improvements in participants' daily lives as reported via EMA - especially in the context of momentary skills use.
H2b: Further, the investigator hypothesize that skill use during laboratory visits and EMA will predict subsequent reductions in life stressors that are dependent on adolescent characteristics and/or behaviors.
Aim 3: Examine persistence/decay effects of skill in daily life following initial skill exposure and a "booster" call.
H3a: Skill use will be most frequent immediately following training and decline over time. H3b: A brief booster call 1 week post-skill exposure will predict increases in EMA reported skill use. The investigator will examine potential moderation effects to determine who may benefit from repeated skill exposure.
H3c: Youth skill use over the EMA period will predict changes in stressor severity experienced over 6-month followup. Specifically, GIVE use will predict less severe dependent stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opposite action | Experimental | Behavioral: Opposite to emotion actionParticipants will be randomly assigned to this arm either first or second. All participants complete both arms. |
| GIVE | Experimental | Behavioral: GIVEParticipants will be randomly assigned to this arm either first or second. All participants complete both arms. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Moderate to severe developmental or intellectual disability, psychosis, or a schizophrenia spectrum diagnosis.
- Those taking medications with well-documented effects on psychophysiological responding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opposite to emotion actionParticipants will be taught the opposite action skill from Dialectical Behavior Therapy | Behavioural | Opposite action |
| GIVEParticipants will be taught the GIVE skill from Dialectical Behavior Therapy | Behavioural | GIVE |
Primary outcome
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)
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
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).
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.
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).
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.
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.
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).
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.
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
Time frame: 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.
3 secondary outcomes
Impact of skills use on life stress as assessed by the Life Events and Difficulties Schedule (LEDS-II)
Time frame: 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)
Time frame: Across approximately 4-5 weeks
Examine changes in emotion regulation/dysregulation from pre- to post-intervention discussion tasks via respiratory sinus arrhythmia (RSA)
Time frame: Across approximately 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes. We will post descriptions of study methods (including Dialectical Behavior Therapy Skills videos) and procedures to our Open Science Framework (OSF) page. All de-identified data and code relevant to the project will be uploaded to OSF upon submission to encourage replications and extensions of our work. In addition to the data for neuroimaging and RDoC domains, demographic and clinical information will be included. Data collected for exploratory aims will be uploaded upon completion of publication and all relevant reports and publications will be made available per the open access policy of NIH.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin Kaufman, Ph.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opposite to emotion action and GIVE in people with Self Injurious Behavior and Suicide, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Kaufman, Ph.D. (8017819433, erin.kaufman@utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.