Can sound and vibration calm troubled teens? new trial aims to find out
NCT ID NCT07364799
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a multi-sensory therapy called Heal, which uses calming sounds, gentle vibrations, and soft lighting to help detained youth (ages 12-18) manage their emotions before counseling sessions. The goal is to see if this brief, non-verbal intervention improves emotional regulation, strengthens the bond with their therapist, and boosts mental health. Only 12 participants will be enrolled, making this a very early-stage trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Multi-sensory emotional regulation intervention (Heal) - a brief, non-verbal behavioral therapy using calming sound, music, low-intensity vibrations, and soft ambient lighting delivered in a distraction-free booth.
- What this could lead to
- If it works, this could offer a simple, non-verbal tool to help detained youth calm down before therapy sessions, potentially improving their emotional control and engagement in treatment.
- What could go wrong
- This is a very small early study with only 12 participants, so results may not apply to all youth. The intervention is brief and may not produce lasting changes in emotional regulation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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San Luis Obispo County Juvenile Hall
RECRUITINGSan Luis Obispo, California, 93401, United States
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