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Tests treatment safety and results for Emotional Dysregulation
Official title Effectiveness of the SoundHeal Multi-Sensory Integrative Therapy Among Justice-Involved Youth
ClinicalTrials.gov ID: NCT07364799
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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)...
- 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.
You likely can't join if
- 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
See the full eligibility 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 only. Recruitment procedures are designed to be fair and free from...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Luis Obispo, California, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Luis Obispo, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.