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

Effectiveness of the SoundHeal (Heal) Multi-Sensory Integrative Therapy in Enhancing Emotional Regulation Among Justice-Involved Youth and Its Effect on Therapeutic Alliance and Mental Health Outcomes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In the "Survey of Youth in Residential Placement," 68% of confined youth reported being "easily upset" and 61% said they "lost their temper easily or felt angry a lot," clear, item-level indicators of ED among detained youth."
  • "Youth will fill out standardized questionnaires after their time inside the Healpod at the start, weekly, and at the end of the 8-week study period."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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

Study sites (1)

CA