SoundHeal Multi-Sensory Therapy for Justice-Involved Youth

This study is looking at how well a new approach called the SoundHeal Multi-Sensory Integrative Therapy works for young people (ages 12-18) who are involved with the justice system. Many of these youth struggle with emotional dysregulation, which means they have trouble managing strong feelings like anger or anxiety. The SoundHeal therapy uses calming sounds and music in a special booth before counseling sessions. The goal is to see if this therapy can help improve emotional regulation. To join, you must be 12-18 years old, detained in SLO County, CA Juvenile Hall with at least an 8-week expected stay, and have a history or current diagnosis of a mental health disorder. The study plans to enroll 12 participants. The current status of the study is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.
What's involved
You would participate in approximately five minutes of calming sound and music sessions before scheduled counseling sessions, for about 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Emotional regulation will be measured at the start, midpoint (week 4), and end of the intervention (week 8 or end of participation).

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NCT07364799

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

Recruiting
NAAges 12–18InterventionalTreatment
SoundHeal
~12 participants
Updated 2026-01-23 on ClinicalTrials.gov
What's tested:Multi-sensory emotional regulation intervention (Heal)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Emotional Regulation
Measured over Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
Emotional Dysregulation
Therapeutic Alliance
Depression Disorder
Anxiety Disorders
Stress Disorders
Substance Use Disorders
Mental Health Disorders
1 sites across 1 states
California1
  • Nishat Bhuiyan, PhD · PRINCIPAL_INVESTIGATOR

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Change in Emotional RegulationBaseline, 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.