Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth
Part of paid clinical trials in San Luis Obispo, California.
- Sponsor
- SoundHeal
- Study ID
- NCT07364799
- Status
- Recruiting
Conditions
- Anxiety Disorders
- Depression Disorder
- Emotional Dysregulation
- Mental Health Disorders
- Stress Disorders
- Substance Use Disorders
- Therapeutic Alliance
Eligibility Criteria
- Sex
- ALL
- Age
- 12 Years - 18 Years
- Healthy Volunteers
- Not accepted
Interventions
- Multi-sensory emotional regulation intervention (Heal) — BEHAVIORALThe multi-sensory emotional regulation intervention (Heal) is a brief, non-verbal behavioral intervention delivered in a single-person, distraction-free booth before scheduled counseling sessions. Each session includes approximately five minutes of calming sound and music, optional low-intensity vibroacoustic stimulation, and soft ambient lighting to support emotional regulation without requiring verbal processing or physical interaction with anyone. Immediately after each session, participants complete a brief writing activity (journaling or drawing) to reflect on their emotional state before, during and after the session. This reflective activity is used to support discussion during a standard therapy session with the clinician after. Sessions are delivered 1 to 2 times per week over eight weeks in addition to standard care. The intervention is non-invasive, supervised for safety, and may be stopped at any time. No medications or invasive procedures are involved.
Study Details
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.
Key Dates
- Start date
- Jan 30, 2026
- Status verified
- Jan 2026
- Primary completion
- Mar 31, 2026
- Completion
- Apr 30, 2026
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Heal InterventionParticipants assigned to this arm will receive the Heal intervention in addition to standard care provided at the juvenile detention facility. The Heal intervention consists of brief, non-verbal, multi-sensory sessions delivered in a single-person booth (the Healpod), combining sound, music, gentle vibration, ambient light, and immediate expressive journaling or drawing prior to scheduled counseling sessions. All participants receive the intervention one to two times per week for approximately eight weeks, and outcomes are assessed using pre- and post-intervention measures.
Primary Outcome Measure
Change in Emotional Regulation [ Time Frame: Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation) ]
Central Contacts
- Mahesh Natrajan, MBA408-230-9070
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| San Luis Obispo County Juvenile Hall | San Luis Obispo | California | 93401 | - |
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