Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth (NCT07364799) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth
United States12 participantsStarted 2026-01-30
Plain-language 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.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 betw…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Emotional Regulation
Timeframe: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)