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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorSoundHeal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Multi-sensory emotional regulation intervention (Heal)

    Behavioral

    The 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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Heal InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Emotional Regulation

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.

Time frame
Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)

Secondary outcomes

1

Change in Therapeutic Alliance

Change in therapeutic alliance will be assessed using the Therapeutic Alliance Scale for Children - Revised (TASC-R), a validated youth-reported measure of perceived trust, collaboration, and engagement with the therapist. Total scores range from 12 to 48, with higher scores indicating a stronger therapeutic alliance (better outcome).

Time frame
Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
2

Change in Coping Skills

Change in coping strategies will be assessed using the Kidcope Checklist of Coping Strategies (KidCOPE), a validated youth self-report measure of adaptive and maladaptive coping responses to stress. The scale includes multiple items rated for use of specific coping strategies, with total scores ranging from 0 to 30, with higher scores indicating greater use of coping strategies (better outcome).

Time frame
Baseline, midpoint (week 4 ±1), and end of intervention (week 8 or end of participation)
3

Change in Depression Symptoms

Change in depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated self-report measure of depressive symptom severity over the prior two weeks. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity (worse outcome).

Time frame
Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)
4

Change in Anxiety Symptoms

Change in anxiety symptoms will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a validated self-report measure of anxiety severity. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity (worse outcome).

Time frame
Baseline and every two weeks during the intervention period (weeks 2, 4, 6, and 8)

Other outcomes

1

Feasibility and Acceptability

Feasibility and acceptability will be assessed through intervention adherence (number of sessions completed), therapist observations of engagement, and qualitative analysis of de-identified participant session journals.

Time frame
Throughout the intervention period (up to 8 weeks)
2

Adverse Events (AEs) and Serious Adverse Events (SAEs)

Safety will be assessed by monitoring and recording the number and type of adverse events and serious adverse events occurring during the study period.

Time frame
Throughout the intervention period (up to 8 weeks)

Sponsors and contacts

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SoundHeal

Lead sponsor

County of San Luis Obispo - Probation Department

Collaborator

County of San Luis Obispo Health Agency

Collaborator