Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth
Recruiting · NCT07364799 · Interventional (participants receive a specific treatment) · Lead sponsor: SoundHeal
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 is running
2 locations listed across 1 US state.
- San Luis Obispo County Juvenile Hall - San Luis Obispo, California, United States
- San Luis Obispo County Juvenile Hall - San Luis Obispo, California, United States