SoundHeal multi-sensory integrative therapy for detained youth with emotional dysregulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study delivers the Heal multi-sensory emotional regulation program to justice-involved youth detained at San Luis Obispo County Juvenile Hall. Participants aged 12–18 with a history or risk of mental health disorders and an expected stay of at least eight weeks will receive the intervention while completing journaling and structured questionnaires to track symptoms and coping. Parent or guardian (or legally authorized representative) consent and youth assent are required, and study staff will monitor engagement and safety during the program. Primary outcomes focus on changes in emotional regulation, arousal, anger, and symptoms of depression and anxiety over the intervention period.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Nishat Bhuiyan, PhD
• Study coordinator: Mahesh Natrajan, MBA
• Email: mahesh@heal.mx
• Phone: 408-230-9070

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.