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NCT07364799 · ClinicalTrials.gov registry record · NA
Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth
A NA study of Substance Use Disorders and Anxiety Disorders, sponsored by SoundHeal.
- Recruiting
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07364799: Recruiting NA study of Substance Use Disorders and Anxiety Disorders, sponsored by SoundHeal.
NCT07364799 is a NA study of Substance Use Disorders and Anxiety Disorders that is actively recruiting participants, run by SoundHeal. The registered enrollment target is 12 participants, below the 500-participant average among 93 other Substance Use Disorders trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07364799, a NA study of Substance Use Disorders and Anxiety Disorders, is actively recruiting participants, sponsored by SoundHeal.
- RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Change in emotional regulation will be assessed using the Difficulties in Emotion Regulation Scale - 16 Item Version (DERS-16), a validated self-report questionnaire measuring difficulties in emotional awareness, clarity, impulse control, and access to emotion regulation strategies. Total scores range from 16 to 80, with higher scores indicating greater emotional dysregulation (worse outcome). The primary endpoint is change in DERS-16 total score from baseline to end of intervention.
Conditions Studied
Interventions
- BEHAVIORAL Multi-sensory emotional regulation intervention (Heal)
Study Locations (1)
California
- San Luis Obispo County Juvenile Hall - San Luis Obispo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-01-30 |
| Est. Completion | 2026-04 |
| Phase | NA |
What NCT07364799 shows while recruiting
NCT07364799 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 500-participant average among 93 other Substance Use Disorders trials with a reported enrollment target (98% lower).
The record links to 7 conditions, with Substance Use Disorders appearing as the primary indexed condition, and to 1 intervention - of which Multi-sensory emotional regulation intervention (Heal) is the first listed.
NCT07364799 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07364799 about?
NCT07364799 is a clinical study titled "Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth". 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 aggre...
What is the current status of trial NCT07364799?
This trial is currently recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2026-01-30. Estimated completion is 2026-04.
What conditions does trial NCT07364799 study?
This clinical trial studies the following conditions: Substance Use Disorders, Anxiety Disorders, Mental Health Disorders, Depression Disorder, Emotional Dysregulation.
What interventions are being tested in trial NCT07364799?
The interventions under investigation include: Multi-sensory emotional regulation intervention (Heal) (BEHAVIORAL).
Who is sponsoring clinical trial NCT07364799?
This trial is sponsored by SoundHeal, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07364799 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT07364799's enrollment target sits among peer trials
12 90th of 93 higher than 3 of 93 other Substance Use Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Substance Use Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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