Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth

NCT07364799 | Recruiting

• 1 other identifier: SHSLOSJC001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Emotional Dysregulation; Therapeutic Alliance; Depression Disorder; Anxiety Disorders; Stress Disorders; Substance Use Disorders; Mental Health Disorders

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)

Secondary Outcomes (6)

• Change in Therapeutic Alliance

  Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)

• Change in Coping Skills

  Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)

• Change in Depression Symptoms

  Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)

• Change in Anxiety Symptoms

  Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)

• Change in Stress Symptoms

  Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)

Other Outcomes (2)

• Feasibility and Acceptability

  Throughout the intervention period (up to 8 weeks)

• Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Throughout the intervention period (up to 8 weeks)

Study Arms (1)

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.

Behavioral: Multi-sensory emotional regulation intervention (Heal)

Interventions

Multi-sensory emotional regulation intervention (Heal) BEHAVIORAL

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.

Also known as: Heal Intervention, Healpod intervention, Soundheal Intervention, Sensory-based emotional regulation intervention

Heal Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Participation: Willingness to comply with the Heal intervention, journaling, and questionnaires
• 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.

You may not qualify if:

• 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
• 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).
• 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

Sponsors & Collaborators

• SoundHeal: lead
• County of San Luis Obispo - Probation Department: collaborator
• County of San Luis Obispo Health Agency: collaborator

Study Sites (1)

San Luis Obispo County Juvenile Hall

San Luis Obispo, California, 93401, United States

RECRUITING

Related Publications (38)

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 31204840 BACKGROUND

• McLaughlin 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.

  PMID: 22752056 BACKGROUND

• Schreiber 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.

  PMID: 22385661 BACKGROUND

• Paulus 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.

  PMID: 34759846 BACKGROUND

• Saskovets 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.

  PMID: 40127440 BACKGROUND

• Dowdy 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.

  PMID: 36340267 BACKGROUND

• Xiao 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.

  PMID: 37250411 BACKGROUND

• Rodriguez 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.

  PMID: 36805103 BACKGROUND

• Krishnan 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.

  PMID: 25499471 BACKGROUND

• Caulfield, L.S. & Wilson, D. (2010). Female offenders' experiences of the arts in criminal justice. Journal of Social Criminology, 3, 67-90.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34545236 BACKGROUND

• Berking 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.

  PMID: 23712210 BACKGROUND

• Compas BE, Jaser SS, Bettis AH, Watson KH, Gruhn MA, Dunbar JP, Williams E, Thigpen JC. Coping, emotion regulation, and psychopathology in childhood and adolescence: A meta-analysis and narrative review. Psychol Bull. 2017 Sep;143(9):939-991. doi: 10.1037/bul0000110. Epub 2017 Jun 15.

  PMID: 28616996 BACKGROUND

• Shantakumari N, Ahmed M. Whole body vibration therapy and cognitive functions: a systematic review. AIMS Neurosci. 2023 May 18;10(2):130-143. doi: 10.3934/Neuroscience.2023010. eCollection 2023.

  PMID: 37426779 BACKGROUND

• Eastburn, C. (2003). Gongs behind bars: Evaluation report of the Good Vibrations Gamelan in Prisons pilot project 2003. Wellingore: The Firebird Trust.

  BACKGROUND

• Digard, L., Grafin von Sponeck, A. & Liebling, A. (2007). All Together Now: The therapeutic potential of a prison-based music programme. The Prison Service Journal, Issue 170, 3-14.

  BACKGROUND

• Braun, V. & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3, 77-101

  BACKGROUND

• Chloe A. Greenbaum, Shabnam Javdani, Expressive writing intervention promotes resilience among juvenile justice-involved youth, Children and Youth Services Review, Volume 73, 2017, Pages 220-229, ISSN 0190-7409, https://doi.org/10.1016/j.childyouth.2016.11.034

  BACKGROUND

• Chong HJ, Yun J. Music Therapy for Delinquency Involved Juveniles Through Tripartite Collaboration: A Mixed Method Study. Front Psychol. 2020 Oct 23;11:589431. doi: 10.3389/fpsyg.2020.589431. eCollection 2020.

  PMID: 33192927 BACKGROUND

• Bryan K, Freer J, Furlong C. Language and communication difficulties in juvenile offenders. Int J Lang Commun Disord. 2007 Sep-Oct;42(5):505-20. doi: 10.1080/13682820601053977.

  PMID: 17729143 BACKGROUND

• Allen CH, Kluger BM, Buard I. Safety of Transcranial Magnetic Stimulation in Children: A Systematic Review of the Literature. Pediatr Neurol. 2017 Mar;68:3-17. doi: 10.1016/j.pediatrneurol.2016.12.009. Epub 2017 Jan 4.

  PMID: 28216033 BACKGROUND

• Fox, A. M., Miksicek, D., and Veele, S. (2019). An evaluation of Dialectical Behavior Therapy in Washington State's Juvenile Rehabilitation. Olympia, WA: Department of Children, Youth, and Families, Office of Innovation, Alignment, and Accountability.

  BACKGROUND

• Folk JB, Yang P, Thomas A, Lyon J, Patel J, Yoon C, Barbara-Robles-Ramamurthy. Comprehensive Dialectical Behavior Therapy for Adolescents in a Juvenile Correctional Treatment Center: A Pilot Evaluation. Front Child Adolesc Psychiatry. 2023;2:1207575. doi: 10.3389/frcha.2023.1207575. Epub 2023 Nov 2.

  PMID: 39220324 BACKGROUND

• Wadsworth ME. Development of Maladaptive Coping: A Functional Adaptation to Chronic, Uncontrollable Stress. Child Dev Perspect. 2015 Jun 1;9(2):96-100. doi: 10.1111/cdep.12112.

  PMID: 26019717 BACKGROUND

• Michael B. Field, BJS Statistician; Elizabeth Davis, BJS Statistician; Amy D. Lauger, BJS Statistician Date Published July 2023 NCJ Number 305814

  BACKGROUND

• Jamie R. Yoder; Kelly Whitaker; Camille R. Quinn. Perceptions of Recidivism Among Incarcerated Youth: The Relationship Between Exposure to Childhood Trauma, Mental Health Status, and the Protective Effect of Mental Health Services in Juvenile Justice Settings. Vol. 18 No. 1 (Spring 2017), 250-269, DOI: 10.18060/21305

  BACKGROUND

• Okuda M, Picazo J, Olfson M, Hasin DS, Liu SM, Bernardi S, Blanco C. Prevalence and correlates of anger in the community: results from a national survey. CNS Spectr. 2015 Apr;20(2):130-9. doi: 10.1017/S1092852914000182.

  PMID: 25831968 BACKGROUND

• Skinner-Osei et al. Justice Policy Journal, Fall, 2019 Justice-Involved Youth and Trauma-Informed Interventions. Justice Policy Journal. Volume 16, Number 2 (Fall, 2019) © Center on Juvenile and Criminal Justice 2019

  BACKGROUND

• Melissa A. Brotman, Ph.D. brotman@mail.nih.gov, Katharina Kircanski, Ph.D., Argyris Stringaris, M.D., Ph.D., Daniel S. Pine, M.D., and Ellen Leibenluft, M.D. Publication: American Journal of Psychiatry Volume 174, Number 6 https://doi.org/10.1176/appi.ajp.2016.1607083

  BACKGROUND

• Carlo Garofalo, Patrizia Velotti, Negative emotionality and aggression in violent offenders: The moderating role of emotion dysregulation, Journal of Criminal Justice, Volume 51, 2017, Pages 9-16, ISSN 0047-2352, https://doi.org/10.1016/j.jcrimjus.2017.05.015.

  BACKGROUND

• Teplin LA, Abram KM, McClelland GM, Dulcan MK, Mericle AA. Psychiatric disorders in youth in juvenile detention. Arch Gen Psychiatry. 2002 Dec;59(12):1133-43. doi: 10.1001/archpsyc.59.12.1133.

  PMID: 12470130 BACKGROUND

• Farnia, V., Golshani, S., Alikhani, M., & Akhondzadeh, S. (2023). Are there any possible side effects of neurofeedback? A systematic literature review and meta-analysis. Iranian Journal of Psychiatry and Behavioral Sciences, 17(4), e138064. https://doi.org/10.5812/ijpbs.138064

  BACKGROUND

• Rahmani E, Rahmanian M, Mansouri K, Mokhayeri Y, Jamalpour Y, et al. Are There any Possible Side Effects of Neurofeedback? A Systematic Literature Review and Meta-analysis.Iran J Psychiatry Behav Sci.2023;17(3):e138064.https://doi.org/10.5812/ijpbs-138064.

  BACKGROUND

• Duchschere JE, Reznik SJ, Shanholtz CE, O'Hara KL, Gerson N, Beck CJ, Lawrence E. Addressing a Mental Health Intervention Gap in Juvenile Detention: A Pilot Study. Evid Based Pract Child Adolesc Ment Health. 2023;8(2):236-251. doi: 10.1080/23794925.2022.2042873. Epub 2022 Apr 20.

  PMID: 37637190 BACKGROUND

• Beaudry G, Yu R, Langstrom N, Fazel S. An Updated Systematic Review and Meta-regression Analysis: Mental Disorders Among Adolescents in Juvenile Detention and Correctional Facilities. J Am Acad Child Adolesc Psychiatry. 2021 Jan;60(1):46-60. doi: 10.1016/j.jaac.2020.01.015. Epub 2020 Feb 5.

  PMID: 32035113 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Traumatic; Substance-Related Disorders; Emotional Regulation

Interventions

Wound Healing

Condition Hierarchy (Ancestors)

Mental Disorders; Trauma and Stressor Related Disorders; Chemically-Induced Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• Nishat Bhuiyan, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahesh Natrajan, MBA

CONTACT

408-230-9070; mahesh@heal.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 23, 2026
• Study Start: January 30, 2026
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)