Emotional DysregulationHEAL-SLOJSCNCT07364799
Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth
A study testing Multi-sensory emotional regulation intervention (Heal) in people with Emotional Dysregulation and Therapeutic Alliance, run by SoundHeal at 1 site in United States.
Trial summary
Emotional dysregulation in justice-involved youth (JIY) is a condition that significantly impacts young people, their families, and juvenile justice and public health systems. Affecting an estimated 60-70% of detained Attention deficit hyperactivity disorderadolescents, it is a major driver of aggression, substance… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Emotional Dysregulation, Therapeutic Alliance, Depression Disorder
- What is being tested?
- Multi-sensory emotional regulation intervention (Heal)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2026to Apr 2026
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age: Youth 12-18 years old. All participants enrolled in this study will be under the age of 18 at time of enrollment.
- Custody: Detained in SLO County, CA Juvenile Hall with at least 8 weeks of expected stay at the time the clinical trial starts
- Diagnosis: Documented history of being at risk or of having a history or current diagnosis of a mental health disorder (depression, anxiety, stress) and/or SUD
- Language/Comprehension: Basic English understanding; accommodations for limited literacy allowed
- Consent/Assent: Eligible juveniles must provide assent, with parent/guardian or Legally Authorized Representative (LAR) consent.
- Ensure that the person providing informed consent understands the information provided, even if that person providing informed consent agrees to be in the research.
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- Participation: Willingness to comply with the Heal intervention, journaling, and questionnaires
- Recruitment and selection participation: Eligible participants will be selected in collaboration with facility behavioral-health staff using objective inclusion criteria only. Recruitment procedures are designed to be fair and free from arbitrary influence by facility administrators or peers.
- Special Considerations: Because participants are minors and incarcerated, safeguards ensure voluntary participation, protection from coercion, age-appropriate communication, and accommodations for literacy or comprehension limits.
Who cannot join
- Age/Status: Not between 12-18 years old, or not currently detained in SLO County Juvenile Hall
- Length of Stay: Expected detention is less than 8 weeks at start of clinical trial
- Clinical Stability: Determined by onsite staff to be medically or psychiatrically unable to participate safely
- Consent/Assent: Unable to provide assent, or if parent/guardian or LAR does not provide consent
- If the person providing informed consent needs more time than is allowed by the research design.
- Language/Comprehension: Cannot understand basic English, even with literacy accommodations
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- Participation: Unwilling to comply with the Heal intervention, journaling, or questionnaires
- Research staff will not personally use the device for research purposes. Their role is limited to facilitating device use for participants and monitoring protocol adherence.
- While the Healpod may be available for non-research use in other settings, this protocol strictly limits its use to the described research procedures. Any non-research use will be separated from this study, and no data will be collected from individuals outside of the study.
- Currently pregnant or becomes pregnant during the study period: If pregnant or pregnancy is discovered during participation, the individual will be withdrawn from the study to prevent any potential discomfort or unknown risk exposure related to the device environment (sound, vibration, or lighting).
- Special Exclusions
- Juveniles whose participation may be influenced by coercion (e.g., enrollment tied to privileges or probation decisions)
- Juveniles with severe cognitive or behavioral impairment that prevents safe or meaningful participation
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
San Luis Obispo County Juvenile Hall
San Luis Obispo, California, 93401
About this study
Official title: Effectiveness of the SoundHeal (Heal) Multi-Sensory Integrative Therapy in Enhancing Emotional Regulation Among Justice-Involved Youth and Its Effect on Therapeutic Alliance and Mental Health Outcomes
Emotional dysregulation in justice-involved youth (JIY) is a condition that significantly impacts young people, their families, and juvenile justice and public health systems. Affecting an estimated 60-70% of detained Attention deficit hyperactivity disorderadolescents, it is a major driver of aggression, substance use, school failure, and later recidivism. Despite available treatments, managing emotional dysregulation in custody remains challenging, with youth often enduring high arousal, anger, and anxiety that persist into adulthood. Current popular therapies, including Cognitive Behavioral Therapy (CBT) and Dialectic Behavioral Therapy (DBT), often fall short in detention because they rely on verbal processing, require multiple scheduled sessions, and/or need highly trained staff. Other technologies, like biofeedback and neurostimulation techniques, are still under scrutiny for adolescents, given their higher-than-usual Adverse Events (AEs).
This SoundHeal study aims to evaluate a sensory intervention using the Healpod, a distraction-free physical space where a participant sits, delivering sound, music, gentle vibrations, and ambient light. Following this is a brief expressive journaling exercise to compare any before, during and after experience changes from the sensory immersion.
This prospective, single-center cohort study hypothesizes that these sessions will improve juveniles' ability to emotionally regulate, improve therapeutic alliance, mental health outcomes and build coping skills that can potentially help in long-term mental health and substance abuse treatment in JIY and beyond.
Read the detailed description
Justice Involved Youth (JIY) often have difficulty with emotional regulation (ER) given all they go through physically, mentally and emotionally. Emotional dysregulation (ED) shows up as difficulty in managing anger and/or impulsivity and reacting rather than calmly responding to challenging situations faced negatively impacting their life.
Research consistently shows that incarcerated populations have far higher rates of ED and mental health disorders than the general youth population. The reason this is important in the context of this study is that ER difficulties act as a contributor to aggression and aggressive behaviors. In nationally representative JIY data, ED is the norm rather than the exception. In the "Survey of Youth in Residential Placement," 68% of confined youth reported being "easily upset" and 61% said they "lost their temper easily or felt angry a lot," clear, item-level indicators of ED among detained youth. By contrast, community studies show much lower rates for comparable constructs: the National Comorbidity Survey-Adolescent Supplement estimates 5.3-7.8% lifetime (and 1.7-6.2% 12-month) prevalence for intermittent explosive disorder, while clinical reviews put severe irritability in community youth at roughly 0.1-5%, and epidemiologic summaries place impairing emotional outbursts in about 4-10% of children and adolescents.
ED shows up as mental health disorders: a large meta-analysis of detained adolescents found strikingly elevated psychiatric morbidity with major depression (10.1% males, 25.8% females), Attention Deficit Hyperactivity Disorder (ADHD)(17.3% males, 17.5% females), and conduct disorder (~62% males, 59% females). By contrast, general U.S. youth have far lower trauma-related burden; for example, lifetime Post Traumatic Stress Disorder (PTSD) is about 5% overall (2.3% males, 8.0% females).
A very similar disproportion also shows up with substance use disorder (SUD) and alcohol use. According to a 2021 Substance Abuse and Mental Health Services Administration (SAMHSA) report, 7.5% of adolescents ages 12-17 had a SUD, 7% drank alcohol in the past month, and 14.1% adolescents drank alcohol in the past year. While this SAMHSA report did not have data on JIY, another 2023 report by the Bureau of Justice Statistics on drug and alcohol use stated that about 60% of youth met the criteria for SUD and 36% for alcohol use disorder, and that more than 63% met the criteria for severe SUD from 2008 to 2018.
Taken together, the data show that ED is not a side issue for JIY, it's a central, measurable driver of what derails treatment and destabilizes custody, conflict, impulsive reactions, misconduct, and worsening symptoms. Hence, there is a need for more effective innovative rehabilitation approaches that may help JIY strengthen ER, encourage therapeutic alliance, help improve mental health outcomes, develop healthy coping skills, and thereby potentially reduce recidivism and relapse rates in the long run.
SoundHeal's sensory-first intervention combines sound, music, gentle vibrations, and ambient light into a focused five-minute HealPod experience that helps bridge emotional dysregulation with mental-health and substance-use treatment.
The findings from this study aim to show that this structured approach can provide meaningful ER, improve therapeutic alliance, overcome mental health ailments, unlock engagement, and strengthen coping for youth who may otherwise remain resistant or disengaged in treatment.
The proposed study is intended to be an 8-week clinical trial. Participating juveniles will be selected from a single-site at SLO County Juvenile Hall for 12- to 18-year-old youth who are under residential treatment. Youth in this facility are ordered to stay 6-12 months and to receive intensive case management, treatment and educational services, making it the ideal population to work with within Juvenile Hall. Participating juveniles will be scheduled to use the Healpod 1-2 times a week before they meet their therapist. They will arrive 10 minutes before their scheduled session with their therapist, use the Healpod for about 5 minutes, and then journal/ write or draw about how they felt before, during and after the session. Therapists see the youth after their session and use the Heal journal as a starting point for talk therapy (Cognitive Behavioral Therapy/Dialectic Behavioral Therapy) treatment.
The Healpod (the tool for treatment) itself is a physical, rounded 4ft x 6ft telephone booth-like space equipped with speakers, low-frequency vibroacoustics, and a touchpad user interface for session selection. Once seated inside the Healpod, participants draw the curtains close and start their session.
The primary objective of this study is to measure ER and the secondary objectives to measure therapeutic engagement and mental health outcomes in treatment. While all show disparities between JIY and the general youth population, as discussed earlier, there is a cause-and-effect relationship between ER and engagement in treatment. The weight of evidence supports a directional, partly causal chain in which improving ER enables more engagement and adaptive coping, which then improves downstream outcomes.
Youth will fill out standardized questionnaires after their time inside the Healpod at the start, weekly, and at the end of the 8-week study period. Additionally, the therapist will fill out their assessment after talk therapy after their session with the youth.
- Conditions
- Emotional Dysregulation, Therapeutic Alliance, Depression Disorder, Anxiety Disorders, Stress Disorders, Substance Use Disorders
- Being tested
- Multi-sensory emotional regulation intervention (Heal)
- Keywords
- Emotional regulation, Emotional dysregulation, Justice-involved youth, Juvenile detention, Sensory-based intervention, multi-sensory stimulation therapy, Multisensory therapy, Sound therapy, music therapy, Vibroacoustic therapy, Therapeutic alliance, Therapy readiness, Mental health outcomes, substance use disorder, Coping skills, Non-verbal intervention, Journaling, Expressive Writing, Mindfulness
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Traumatic, Substance-Related Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-sensory emotional regulation intervention (Heal)Behavioural
Also called Heal Intervention, Healpod intervention, Soundheal Intervention, Sensory-based emotional regulation intervention
The multi-sensory emotional regulation intervention (Heal) is a brief, non-verbal behavioral intervention delivered in a single-person, distraction-free booth before scheduled counseling sessions. Each session includes approximately five minutes of calming sound and music, optional low-intensity vibroacoustic stimulation, and soft ambient lighting to support emotional regulation without requiring verbal processing or physical interaction with anyone.
Immediately after each session, participants complete a brief writing activity (journaling or drawing) to reflect on their emotional state before, during and after the session. This reflective activity is used to support discussion during a standard therapy session with the clinician after.
Sessions are delivered 1 to 2 times per week over eight weeks in addition to standard care. The intervention is non-invasive, supervised for safety, and may be stopped at any time. No medications or invasive procedures are involved.
| Study group | Role | What they receive |
|---|---|---|
| Heal Intervention | Experimental | Participants assigned to this arm will receive the Heal intervention in addition to standard care provided at the juvenile detention facility. The Heal intervention consists of brief, non-verbal, multi-sensory sessions delivered in a single-person booth (the Healpod), combining sound, music, gentle vibration, ambient light, and immediate expressive journaling or drawing prior to scheduled counseling sessions. All participants receive the intervention one to two times per week for approximately eight weeks, and outcomes are assessed using pre- and post-intervention measures. Receives: Behavioral: Multi-sensory emotional regulation intervention (Heal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Emotional Regulation
Change in emotional regulation will be assessed using the Difficulties in Emotion Regulation Scale - 16 Item Version (DERS-16), a validated self-report questionnaire measuring difficulties in emotional awareness, clarity, impulse control, and access to emotion regulation strategies. Total scores range from 16 to 80, with higher scores indicating greater emotional dysregulation (worse outcome). The primary endpoint is change in DERS-16 total score from baseline to end of intervention.
Measured: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
Secondary outcomes (6)
Change in Therapeutic Alliance
Change in therapeutic alliance will be assessed using the Therapeutic Alliance Scale for Children - Revised (TASC-R), a validated youth-reported measure of perceived trust, collaboration, and engagement with the therapist. Total scores range from 12 to 48, with higher scores indicating a stronger therapeutic alliance (better outcome).
Measured: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
Change in Coping Skills
Change in coping strategies will be assessed using the Kidcope Checklist of Coping Strategies (KidCOPE), a validated youth self-report measure of adaptive and maladaptive coping responses to stress. The scale includes multiple items rated for use of specific coping strategies, with total scores ranging from 0 to 30, with higher scores indicating greater use of coping strategies (better outcome).
Measured: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
Change in Depression Symptoms
Change in depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated self-report measure of depressive symptom severity over the prior two weeks. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity (worse outcome).
Measured: Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)
Change in Anxiety Symptoms
Change in anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a validated self-report measure of anxiety severity. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity (worse outcome).
Measured: Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)
Change in Stress Symptoms
Change in perceived stress will be assessed using the Perceived Stress Scale - 4 Item Version (PSS-4), a validated self-report measure of the degree to which situations in one's life are appraised as stressful. Total scores range from 0 to 16, with higher scores indicating greater perceived stress (worse outcome).
Measured: Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)
Change in Interoceptive Awareness
Interoceptive awareness will be assessed using the Multidimensional Assessment of Interoceptive Awareness - Youth Version (MAIA-Y), a validated self-report measure assessing awareness of internal bodily sensations and their relationship to emotional and regulatory processes. Scale scores range from 1 to 6, with higher scores indicating greater interoceptive awareness and self-regulation (better outcome).
Measured: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start30 Jan 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Emotional DysregulationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, open-label, pre-post study in which all enrolled participants receive the Heal intervention in addition to standard care, and outcomes are assessed by comparing within-participant changes from baseline to post-intervention over eight weeks.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SoundHeal
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- County of San Luis Obispo - Probation Department, County of San Luis Obispo Health Agency
- Responsible party
- Sponsor
- Investigators
- Nishat Bhuiyan, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07364799
- Sponsor's protocol ID
- SHSLOSJC001
- Acronym
- HEAL-SLOJSC
- Status last verified
- Jan 2026
- First submitted
- 21 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sedlak, A. J., & McPherson, K. S. (2010). Youth's needs and services: Findings from the Survey of Youth in Residential Placement. Juvenile Justice Bulletin, Office of Juvenile Justice and Delinquency Prevention. https://www.ojp.gov/pdffiles1/ojjdp/227728.pdf
Skinner-Osei, P., Mangan, L., Liggett, M., Kerrigan, M., & Levenson, J. S. (2019). Justice-involved youth and trauma-informed interventions. Justice Policy Journal, 16(2), 1-25. https://www.cjcj.org/media/import/documents/justice-involved_youth_and_trauma-informed_interventions.pdf
Kelly EL, Novaco RW, Cauffman E. Anger and depression among incarcerated male youth: Predictors of violent and nonviolent offending during adjustment to incarceration. J Consult Clin Psychol. 2019 Aug;87(8):693-705. doi: 10.1037/ccp0000420. Epub 2019 Jun 17.
PubMed 31204840McLaughlin KA, Green JG, Hwang I, Sampson NA, Zaslavsky AM, Kessler RC. Intermittent explosive disorder in the National Comorbidity Survey Replication Adolescent Supplement. Arch Gen Psychiatry. 2012 Nov;69(11):1131-9. doi: 10.1001/archgenpsychiatry.2012.592.
PubMed 22752056Schreiber LR, Grant JE, Odlaug BL. Emotion regulation and impulsivity in young adults. J Psychiatr Res. 2012 May;46(5):651-8. doi: 10.1016/j.jpsychires.2012.02.005. Epub 2012 Mar 3.
PubMed 22385661Paulus FW, Ohmann S, Mohler E, Plener P, Popow C. Emotional Dysregulation in Children and Adolescents With Psychiatric Disorders. A Narrative Review. Front Psychiatry. 2021 Oct 25;12:628252. doi: 10.3389/fpsyt.2021.628252. eCollection 2021.
PubMed 34759846Saskovets M, Saponkova I, Liang Z. Effects of Sound Interventions on the Mental Stress Response in Adults: Scoping Review. JMIR Ment Health. 2025 Mar 24;12:e69120. doi: 10.2196/69120.
PubMed 40127440Dowdy R, Estes J, McCarthy C, Onders J, Onders M, Suttner A. The Influence of Occupational Therapy on Self-Regulation in Juvenile Offenders. J Child Adolesc Trauma. 2022 Nov 2;16(2):221-232. doi: 10.1007/s40653-022-00493-y. eCollection 2023 Jun.
PubMed 36340267Xiao X, Chen W, Zhang X. The effect and mechanisms of music therapy on the autonomic nervous system and brain networks of patients of minimal conscious states: a randomized controlled trial. Front Neurosci. 2023 May 12;17:1182181. doi: 10.3389/fnins.2023.1182181. eCollection 2023.
PubMed 37250411Rodriguez M, Kross E. Sensory emotion regulation. Trends Cogn Sci. 2023 Apr;27(4):379-390. doi: 10.1016/j.tics.2023.01.008. Epub 2023 Feb 15.
PubMed 36805103Krishnan C, Santos L, Peterson MD, Ehinger M. Safety of noninvasive brain stimulation in children and adolescents. Brain Stimul. 2015 Jan-Feb;8(1):76-87. doi: 10.1016/j.brs.2014.10.012. Epub 2014 Oct 28.
PubMed 25499471Caulfield, L.S. & Wilson, D. (2010). Female offenders' experiences of the arts in criminal justice. Journal of Social Criminology, 3, 67-90.
Jennie L. Shufelt, M.S.; Joseph J. Cocozza, Ph.D. Youth with Mental Health Disorders in the Juvenile Justice System: Results From a Multi-State Prevalence Study.
Daros AR, Haefner SA, Asadi S, Kazi S, Rodak T, Quilty LC. A meta-analysis of emotional regulation outcomes in psychological interventions for youth with depression and anxiety. Nat Hum Behav. 2021 Oct;5(10):1443-1457. doi: 10.1038/s41562-021-01191-9. Epub 2021 Sep 20.
PubMed 34545236Berking M, Ebert D, Cuijpers P, Hofmann SG. Emotion regulation skills training enhances the efficacy of inpatient cognitive behavioral therapy for major depressive disorder: a randomized controlled trial. Psychother Psychosom. 2013;82(4):234-45. doi: 10.1159/000348448. Epub 2013 May 22.
PubMed 23712210
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the SoundHeal (Heal) Multi-Sensory Integrative Therapy in Enhancing Emotional Regulation Among Justice-Involved Youth and Its Effect on Therapeutic Alliance and Mental Health Outcomes
- ClinicalTrials.gov ID
- NCT07364799
- Acronym / sponsor ID
- HEAL-SLOJSC / SHSLOSJC001
- Conditions
- Emotional Dysregulation, Therapeutic Alliance, Depression Disorder, Anxiety Disorders, Stress Disorders, Substance Use Disorders
- Keywords
- Emotional regulation, Emotional dysregulation, Justice-involved youth, Juvenile detention, Sensory-based intervention, multi-sensory stimulation therapy, Multisensory therapy, Sound therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- SoundHealIndustry (pharma, biotech, devices)
- Collaborators
- County of San Luis Obispo - Probation Department, County of San Luis Obispo Health Agency
- Study start
- 30 Jan 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 23 Jan 2026 (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.
Emotional dysregulation in justice-involved youth (JIY) is a condition that significantly impacts young people, their families, and juvenile justice and public health systems. Affecting an estimated 60-70% of detained Attention deficit hyperactivity disorderadolescents, it is a major driver of aggression, substance use, school failure, and later recidivism. Despite available treatments, managing emotional dysregulation in custody remains challenging, with youth often enduring high arousal, anger, and anxiety that persist into adulthood. Current popular therapies, including Cognitive Behavioral Therapy (CBT) and Dialectic Behavioral Therapy (DBT), often fall short in detention because they rely on verbal processing, require multiple scheduled sessions, and/or need highly trained staff. Other technologies, like biofeedback and neurostimulation techniques, are still under scrutiny for adolescents, given their higher-than-usual Adverse Events (AEs).
This SoundHeal study aims to evaluate a sensory intervention using the Healpod, a distraction-free physical space where a participant sits, delivering sound, music, gentle vibrations, and ambient light. Following this is a brief expressive journaling exercise to compare any before, during and after experience changes from the sensory immersion.
This prospective, single-center cohort study hypothesizes that these sessions will improve juveniles' ability to emotionally regulate, improve therapeutic alliance, mental health outcomes and build coping skills that can potentially help in long-term mental health and substance abuse treatment in JIY and beyond.
Detailed description
Justice Involved Youth (JIY) often have difficulty with emotional regulation (ER) given all they go through physically, mentally and emotionally. Emotional dysregulation (ED) shows up as difficulty in managing anger and/or impulsivity and reacting rather than calmly responding to challenging situations faced negatively impacting their life.
Research consistently shows that incarcerated populations have far higher rates of ED and mental health disorders than the general youth population. The reason this is important in the context of this study is that ER difficulties act as a contributor to aggression and aggressive behaviors. In nationally representative JIY data, ED is the norm rather than the exception. In the "Survey of Youth in Residential Placement," 68% of confined youth reported being "easily upset" and 61% said they "lost their temper easily or felt angry a lot," clear, item-level indicators of ED among detained youth. By contrast, community studies show much lower rates for comparable constructs: the National Comorbidity Survey-Adolescent Supplement estimates 5.3-7.8% lifetime (and 1.7-6.2% 12-month) prevalence for intermittent explosive disorder, while clinical reviews put severe irritability in community youth at roughly 0.1-5%, and epidemiologic summaries place impairing emotional outbursts in about 4-10% of children and adolescents.
ED shows up as mental health disorders: a large meta-analysis of detained adolescents found strikingly elevated psychiatric morbidity with major depression (10.1% males, 25.8% females), Attention Deficit Hyperactivity Disorder (ADHD)(17.3% males, 17.5% females), and conduct disorder (~62% males, 59% females). By contrast, general U.S. youth have far lower trauma-related burden; for example, lifetime Post Traumatic Stress Disorder (PTSD) is about 5% overall (2.3% males, 8.0% females).
A very similar disproportion also shows up with substance use disorder (SUD) and alcohol use. According to a 2021 Substance Abuse and Mental Health Services Administration (SAMHSA) report, 7.5% of adolescents ages 12-17 had a SUD, 7% drank alcohol in the past month, and 14.1% adolescents drank alcohol in the past year. While this SAMHSA report did not have data on JIY, another 2023 report by the Bureau of Justice Statistics on drug and alcohol use stated that about 60% of youth met the criteria for SUD and 36% for alcohol use disorder, and that more than 63% met the criteria for severe SUD from 2008 to 2018.
Taken together, the data show that ED is not a side issue for JIY, it's a central, measurable driver of what derails treatment and destabilizes custody, conflict, impulsive reactions, misconduct, and worsening symptoms. Hence, there is a need for more effective innovative rehabilitation approaches that may help JIY strengthen ER, encourage therapeutic alliance, help improve mental health outcomes, develop healthy coping skills, and thereby potentially reduce recidivism and relapse rates in the long run.
SoundHeal's sensory-first intervention combines sound, music, gentle vibrations, and ambient light into a focused five-minute HealPod experience that helps bridge emotional dysregulation with mental-health and substance-use treatment.
The findings from this study aim to show that this structured approach can provide meaningful ER, improve therapeutic alliance, overcome mental health ailments, unlock engagement, and strengthen coping for youth who may otherwise remain resistant or disengaged in treatment.
The proposed study is intended to be an 8-week clinical trial. Participating juveniles will be selected from a single-site at SLO County Juvenile Hall for 12- to 18-year-old youth who are under residential treatment. Youth in this facility are ordered to stay 6-12 months and to receive intensive case management, treatment and educational services, making it the ideal population to work with within Juvenile Hall. Participating juveniles will be scheduled to use the Healpod 1-2 times a week before they meet their therapist. They will arrive 10 minutes before their scheduled session with their therapist, use the Healpod for about 5 minutes, and then journal/ write or draw about how they felt before, during and after the session. Therapists see the youth after their session and use the Heal journal as a starting point for talk therapy (Cognitive Behavioral Therapy/Dialectic Behavioral Therapy) treatment.
The Healpod (the tool for treatment) itself is a physical, rounded 4ft x 6ft telephone booth-like space equipped with speakers, low-frequency vibroacoustics, and a touchpad user interface for session selection. Once seated inside the Healpod, participants draw the curtains close and start their session.
The primary objective of this study is to measure ER and the secondary objectives to measure therapeutic engagement and mental health outcomes in treatment. While all show disparities between JIY and the general youth population, as discussed earlier, there is a cause-and-effect relationship between ER and engagement in treatment. The weight of evidence supports a directional, partly causal chain in which improving ER enables more engagement and adaptive coping, which then improves downstream outcomes.
Youth will fill out standardized questionnaires after their time inside the Healpod at the start, weekly, and at the end of the 8-week study period. Additionally, the therapist will fill out their assessment after talk therapy after their session with the youth.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, open-label, pre-post study in which all enrolled participants receive the Heal intervention in addition to standard care, and outcomes are assessed by comparing within-participant changes from baseline to post-intervention over eight weeks.
| Arm | Type | Receives |
|---|---|---|
| Heal Intervention | Experimental | Behavioral: Multi-sensory emotional regulation intervention (Heal)Participants assigned to this arm will receive the Heal intervention in addition to standard care provided at the juvenile detention facility. The Heal intervention consists of brief, non-verbal, multi-sensory sessions delivered in a single-person booth (the Healpod), combining sound, music, gentle vibration, ambient light, and immediate expressive journaling or drawing prior to scheduled counseling sessions. All participants receive the intervention one to two times per week for approximately eight weeks, and outcomes are assessed using pre- and post-intervention measures. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age: Youth 12-18 years old. All participants enrolled in this study will be under the age of 18 at time of enrollment.
- Custody: Detained in SLO County, CA Juvenile Hall with at least 8 weeks of expected stay at the time the clinical trial starts
- Diagnosis: Documented history of being at risk or of having a history or current diagnosis of a mental health disorder (depression, anxiety, stress) and/or SUD
- Language/Comprehension: Basic English understanding; accommodations for limited literacy allowed
- Consent/Assent: Eligible juveniles must provide assent, with parent/guardian or Legally Authorized Representative (LAR) consent.
Key exclusion criteria (13 listed)
- Age/Status: Not between 12-18 years old, or not currently detained in SLO County Juvenile Hall
- Length of Stay: Expected detention is less than 8 weeks at start of clinical trial
- Clinical Stability: Determined by onsite staff to be medically or psychiatrically unable to participate safely
- Consent/Assent: Unable to provide assent, or if parent/guardian or LAR does not provide consent
- If the person providing informed consent needs more time than is allowed by the research design.
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 |
|---|---|---|
| Multi-sensory emotional regulation intervention (Heal)Also: Heal Intervention, Healpod intervention, Soundheal Intervention, Sensory-based emotional regulation interventionThe multi-sensory emotional regulation intervention (Heal) is a brief, non-verbal behavioral intervention delivered in a single-person, distraction-free booth before scheduled counseling sessions. Each session includes approximately five minutes of calming sound and music, optional low-intensity vibroacoustic stimulation, and soft ambient lighting to support emotional regulation without requiring verbal processing or physical interaction with anyone. Immediately after each session, participants complete a brief writing activity (journaling or drawing) to reflect on their emotional state before, during and after the session. This reflective activity is used to support discussion during a standard therapy session with the clinician after. Sessions are delivered 1 to 2 times per week over eight weeks in addition to standard care. The intervention is non-invasive, supervised for safety, and may be stopped at any time. No medications or invasive procedures are involved. | Behavioural | Heal Intervention |
Primary outcome
Change in Emotional Regulation
Time frame: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
Change in emotional regulation will be assessed using the Difficulties in Emotion Regulation Scale - 16 Item Version (DERS-16), a validated self-report questionnaire measuring difficulties in emotional awareness, clarity, impulse control, and access to emotion regulation strategies. Total scores range from 16 to 80, with higher scores indicating greater emotional dysregulation (worse outcome). The primary endpoint is change in DERS-16 total score from baseline to end of intervention.
6 secondary outcomes
Change in Therapeutic Alliance
Time frame: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
Change in Coping Skills
Time frame: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
Change in Depression Symptoms
Time frame: Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)
Change in Anxiety Symptoms
Time frame: Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)
Change in Stress Symptoms
Time frame: Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)
Change in Interoceptive Awareness
Time frame: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
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 23 Jan 2026.
- BackgroundSedlak, A. J., & McPherson, K. S. (2010). Youth's needs and services: Findings from the Survey of Youth in Residential Placement. Juvenile Justice Bulletin, Office of Juvenile Justice and Delinquency Prevention. https://www.ojp.gov/pdffiles1/ojjdp/227728.pdf
- BackgroundSkinner-Osei, P., Mangan, L., Liggett, M., Kerrigan, M., & Levenson, J. S. (2019). Justice-involved youth and trauma-informed interventions. Justice Policy Journal, 16(2), 1-25. https://www.cjcj.org/media/import/documents/justice-involved_youth_and_trauma-informed_interventions.pdf
- Background: PubMed 31204840Kelly EL, Novaco RW, Cauffman E. Anger and depression among incarcerated male youth: Predictors of violent and nonviolent offending during adjustment to incarceration. J Consult Clin Psychol. 2019 Aug;87(8):693-705. doi: 10.1037/ccp0000420. Epub 2019 Jun 17.
- Background: PubMed 22752056McLaughlin KA, Green JG, Hwang I, Sampson NA, Zaslavsky AM, Kessler RC. Intermittent explosive disorder in the National Comorbidity Survey Replication Adolescent Supplement. Arch Gen Psychiatry. 2012 Nov;69(11):1131-9. doi: 10.1001/archgenpsychiatry.2012.592.
- Background: PubMed 22385661Schreiber LR, Grant JE, Odlaug BL. Emotion regulation and impulsivity in young adults. J Psychiatr Res. 2012 May;46(5):651-8. doi: 10.1016/j.jpsychires.2012.02.005. Epub 2012 Mar 3.
- Background: PubMed 34759846Paulus FW, Ohmann S, Mohler E, Plener P, Popow C. Emotional Dysregulation in Children and Adolescents With Psychiatric Disorders. A Narrative Review. Front Psychiatry. 2021 Oct 25;12:628252. doi: 10.3389/fpsyt.2021.628252. eCollection 2021.
- Background: PubMed 40127440Saskovets M, Saponkova I, Liang Z. Effects of Sound Interventions on the Mental Stress Response in Adults: Scoping Review. JMIR Ment Health. 2025 Mar 24;12:e69120. doi: 10.2196/69120.
- Background: PubMed 36340267Dowdy R, Estes J, McCarthy C, Onders J, Onders M, Suttner A. The Influence of Occupational Therapy on Self-Regulation in Juvenile Offenders. J Child Adolesc Trauma. 2022 Nov 2;16(2):221-232. doi: 10.1007/s40653-022-00493-y. eCollection 2023 Jun.
- Background: PubMed 37250411Xiao X, Chen W, Zhang X. The effect and mechanisms of music therapy on the autonomic nervous system and brain networks of patients of minimal conscious states: a randomized controlled trial. Front Neurosci. 2023 May 12;17:1182181. doi: 10.3389/fnins.2023.1182181. eCollection 2023.
- Background: PubMed 36805103Rodriguez M, Kross E. Sensory emotion regulation. Trends Cogn Sci. 2023 Apr;27(4):379-390. doi: 10.1016/j.tics.2023.01.008. Epub 2023 Feb 15.
- Background: PubMed 25499471Krishnan C, Santos L, Peterson MD, Ehinger M. Safety of noninvasive brain stimulation in children and adolescents. Brain Stimul. 2015 Jan-Feb;8(1):76-87. doi: 10.1016/j.brs.2014.10.012. Epub 2014 Oct 28.
- BackgroundCaulfield, L.S. & Wilson, D. (2010). Female offenders' experiences of the arts in criminal justice. Journal of Social Criminology, 3, 67-90.
- Individual participant dataSharing planned: No
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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.
Nishat Bhuiyan, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-sensory emotional regulation intervention (Heal) in people with Emotional Dysregulation and Therapeutic Alliance, run by SoundHeal 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 9 inclusion and 13 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 23 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 Mahesh Natrajan, MBA (408-230-9070, mahesh@heal.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Emotional Regulation (time frame: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07364799, which also lists 38 linked publications.
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 23 Jan 2026.