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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Multi-sensory emotional regulation intervention (Heal)
  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

Первичные конечные точки

• Change in Emotional Regulation [Срок оценки: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)]

Вторичные конечные точки (6)

• Change in Therapeutic Alliance [Срок оценки: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)]
• Change in Coping Skills [Срок оценки: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)]
• Change in Depression Symptoms [Срок оценки: Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)]
• Change in Anxiety Symptoms [Срок оценки: Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)]
• Change in Stress Symptoms [Срок оценки: Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)]
• Change in Interoceptive Awareness [Срок оценки: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)]

Критерии участия

Критерии включения

• 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
• 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.

Критерии исключения

• 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).

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• San Luis Obispo County Juvenile Hall — San Luis Obispo

Публикации

• 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. PMID 31204840
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07364799 · SHSLOSJC001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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