NCT07364799 Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth
| NCT ID | NCT07364799 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SoundHeal |
| Condition | Emotional Dysregulation |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-01-30 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2026-01-30 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Nishat Bhuiyan, PhD
PRINCIPAL INVESTIGATOR
Frequently Asked Questions
Who can join the NCT07364799 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Emotional Dysregulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07364799 currently recruiting?
Yes, NCT07364799 is actively recruiting participants. Contact the research team at mahesh@heal.mx for enrollment information.
Where is the NCT07364799 trial being conducted?
This trial is being conducted at San Luis Obispo, United States.
Who is sponsoring the NCT07364799 clinical trial?
NCT07364799 is sponsored by SoundHeal. The principal investigator is Nishat Bhuiyan, PhD. The trial plans to enroll 12 participants.