Gaze-Contingent Music Therapy to Help Kids with Anxiety

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of Gaze-Contingent Music Reward Therapy (GCMRT) when combined with Cognitive Behavioral Therapy (CBT) for children and adolescents suffering from anxiety disorders. Participants aged 8 to 17 will receive weekly CBT sessions for four weeks, followed by random assignment to either active or control GCMRT for an additional nine weeks. The primary goal is to assess the reduction in anxiety severity as rated by clinicians using the Pediatric Anxiety Rating Scale (PARS). The study aims to determine if the addition of GCMRT enhances the outcomes of standard CBT.

Why it matters

Who can join: the full rules

* INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Ability of subject and parent to understand the study and the willingness to assent/consent into the study.
2. Males and females; Age 8-17
3. Clinician confirmed diagnosis of ongoing separation anxiety disorder, generalized anxiety disorder, or social anxiety disorder. A clinician will review a KSADS-PL DSM-5 (November 2016) (Kiddie Schedule for Affective Disorders and Schizophrenia for School Aged Children) interview, which will have occurred on Protocol 01-M-0192, to confirm diagnosis
4. Willingness to adhere to 12 weekly in-person sessions of CBT
5. Enrolled in Protocol 01-M-0192
6. Subjects must speak, read and write English to be able to participate
7. All subjects will have IQ\>70 as assessed by a WASI or assessment by trained clinical staff which will have occurred under Protocol 01-M-0192

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Current use of any psychotropic medication
2. Ongoing participation in another treatment or intervention study
3. Ongoing mental health treatment outside of NIH
4. Any mental health diagnosis aside from an anxiety disorder as determined by the Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS)
5. Any serious medical conditions
6. Restrictions that preclude in-person attendance of therapy

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Daniel S Pine, M.D. — National Institute of Mental Health (NIMH)
• Study coordinator: Daniel S Pine, M.D.
• Email: daniel.pine@nih.gov
• Phone: (301) 594-1318

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.