Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth (HEAL-SLOJSC)

January 16, 2026 updated by: SoundHeal

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mahesh Natrajan, MBA
  • Phone Number: 408-230-9070
  • Email: mahesh@heal.mx

Study Locations

  • United States
    • California
      • San Luis Obispo, California, United States, 93401
        • Recruiting
        • San Luis Obispo County Juvenile Hall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heal Intervention
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)

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.

Other Names:
  • Heal Intervention
  • Healpod intervention
  • Soundheal Intervention
  • Sensory-based emotional regulation intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Therapeutic Alliance
Time Frame: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
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).
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 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).
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 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).
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 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).
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 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).
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)
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).
Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility and Acceptability
Time Frame: Throughout the intervention period (up to 8 weeks)
Feasibility and acceptability will be assessed through intervention adherence (number of sessions completed), therapist observations of engagement, and qualitative analysis of de-identified participant session journals.
Throughout the intervention period (up to 8 weeks)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Throughout the intervention period (up to 8 weeks)
Safety will be assessed by monitoring and recording the number and type of adverse events and serious adverse events occurring during the study period.
Throughout the intervention period (up to 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SoundHeal

Collaborators

County of San Luis Obispo - Probation Department
County of San Luis Obispo Health Agency

Investigators

  • Principal Investigator: Nishat Bhuiyan, PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 30, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

December 21, 2025

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHSLOSJC001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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