Safety of noninvasive brain stimulation in children and adolescents.
Chandramouli Krishnan, Luciana Santos, Mark D Peterson...
https://pubmed.ncbi.nlm.nih.gov/25499471/Actively Recruiting
Led by SoundHeal · Updated on 2026-01-23
12
Participants Needed
1
Research Sites
4 weeks
Total Duration
Emotional dysregulation is a significant challenge among justice-involved youth JIY, affecting many detained adolescents with conditions like ADHD, depression, anxiety, and substance use disorders. This research evaluates the SoundHeal multi-sensory integrative therapy, designed to improve emotional regulation, therapeutic alliance, and mental health outcomes in these young people. The study focuses on youth aged 12 to 18 years in juvenile detention who often face difficulties with anger, impulsivity, and engagement in treatment. The study uses the Healpod, a small, private booth delivering sound, music, gentle vibrations, and ambient light for about five minutes per session. Participants use the Healpod one to two times a week for eight weeks before their scheduled therapy sessions. After each session, they complete a brief journaling or drawing activity to reflect on their feelings, which therapists use to guide talk therapy. This intervention is given alongside standard care at the detention facility and does not involve medications or invasive procedures. Participants will attend the Healpod sessions and complete questionnaires at the start, weekly, and end of the eight-week study. Therapists will assess therapeutic engagement after each counseling session. Researchers will measure changes in emotional regulation, coping skills, depression, anxiety, stress, and interoceptive awareness throughout the study. The study aims to understand how this sensory approach may support long-term mental health and substance use treatment in detained youth.
CONDITIONS
Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth
M
Mahesh Natrajan, MBA
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SoundHeal
Lead Sponsor
County of San Luis Obispo - Probation Department
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Heal Intervention (Trial) | Current Behavioral Therapy (External Context) |
|---|---|---|
| What it is | A brief, non-verbal behavioral intervention combining calming sound, music, optional low-intensity vibration, and soft lighting in a distraction-free booth before counseling sessions. Includes structured journaling or drawing to support emotional reflection. | Standard behavioral therapies for detained youth including individual counseling, group sessions, and dialectical behavior therapy (DBT) skills training, typically delivered through therapist-led sessions focusing on emotional regulation, coping, and therapeutic alliance. |
| Role in the trial | Add-on intervention administered before scheduled counseling sessions, designed to support emotional regulation in detained youth. | Primary behavioral approach for emotional/mental health disorders in detained youth; used as standard care and clinical context for this comparison, but not studied as an arm in this trial. |
| Evidence status | Currently under prospective study; published registry and literature reviews show potential for sound/vibration-based emotion regulation in youth, but results for this intervention are not yet established. | Behavioral therapies like DBT, group counseling, and occupational therapy are established to improve emotion regulation, reduce depressive/anxiety symptoms, and enhance therapeutic alliance in justice-involved youth. |
| Important limitations | Intervention does not replace standard counseling, is delivered only to youth able to participate for 8 weeks, and effect on longer-term outcomes versus standard care remains untested. Small sample size and single-site limits generalizability. | Behavioral therapies require skilled staff, regular sessions, and participant engagement; effectiveness may be limited by literacy, cognitive impairment, or justice system constraints. Outcomes in detained youth may be affected by environmental and social factors. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive the Heal intervention, consisting of 5-minute multi-sensory sessions in the Healpod 1 to 2 times per week before scheduled counseling sessions, followed by journaling or drawing to reflect on their emotional state. This is combined with standard care and talk therapy.
1 to 2 visits per week for 8 weeks
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Lead Sponsor
County of San Luis Obispo - Probation Department
Collaborating Sponsor