The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens

SCARED anxiety scale score

The Screen for Child Anxiety Related Disorders (SCARED) is a 41-item inventory rated on a 3 point Likert-type scale. It comes in two versions; one asks questions to parents about their child and the other asks these same questions to the child directly. The purpose of the instrument is to screen for signs of anxiety disorders in children.

Time frame: 12-month Follow Up

End-tidal carbon dioxide (CO2)

End-tidal CO2 at 4 weeks Measured using Freespira breathing system 4 minutes breathing session Parameters number of millimeters per mercury.

Time frame: 4 weeks

Respiratory rate level

Respiratory rate at 4 weeks Measured using Freespira breathing system 4 minutes breathing session. The parameters are number of breaths per minute.

Time frame: 4 weeks

Panic Disorder Severity Scale for Adolescents (PDSS-A)

Panic Disorder Severity Scale for Adolescents \[PDSS-A\] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.

Time frame: Baseline

Panic Disorder Severity Scale for Adolescents (PDSS-A)

Panic Disorder Severity Scale for Adolescents \[PDSS-A\] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.

Time frame: Week 4 Follow Up

Panic Disorder Severity Scale for Adolescents (PDSS-A)

Panic Disorder Severity Scale for Adolescents \[PDSS-A\] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.

Time frame: Week 8 Follow Up

Panic Disorder Severity Scale for Adolescents (PDSS-A)

Panic Disorder Severity Scale for Adolescents \[PDSS-A\] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.

Time frame: 6-Month Follow Up

Panic Disorder Severity Scale for Adolescents (PDSS-A)

Panic Disorder Severity Scale for Adolescents \[PDSS-A\] seven question scale referring to panic attacks and symptoms during each episode and how severe the attacks were. Each question is given a rating from 0-4 and the total score from each of the seven questions becomes the score used to assess severity. The higher the score the more severe the panic disorder.

Time frame: 12 month Follow Up

Clinician's Global Impression scale.

Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score. This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.

Time frame: Baseline

Clinician's Global Impression scale.

Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score. This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.

Time frame: Week 4 Follow Up

Clinician's Global Impression scale.

Clinician's Global Impression (CGI) scale is a three item observer rated scale that measures illness severity, global improvement or change, and therapeutic response. It is rated on a seven point scale with the severity of illness scale using a range of responses from one (normal) to seven (around the most severely ill patients). Each component of the CGI is rated separately; the instrument does not yield a global score. This will serve as the measure of overall improvement in the patients symptoms because of the FBS treatment.

Time frame: Week 8 Follow Up

Child Yale Brown Obsessive-Compulsive Scale score

Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.

Time frame: Baseline

Child Yale Brown Obsessive-Compulsive Scale score

Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.

Time frame: Week 4 Follow Up

Child Yale Brown Obsessive-Compulsive Scale score

Child Yale Brown Obsessive-Compulsive Scale is a measure of obsessive compulsion disorder symptoms. This scale is designed to rate the severity of obsessive and compulsive symptoms in children from 6-17 years. In general the ratings depend on the child's and parents report; however the final rating is based on the clinical judgement of the interviewer. The characteristics of each item over the prior week up until; and including, the time of the interview are rated. The child's symptoms are scored using the compulsions checklist and the obsessions checklist as guides. All 19 items are rated but only items 1-10 are used to determine the final score. The total score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. This will be measured through out the study to see the effectiveness of the treatment.

Time frame: Week 8 Follow Up

Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)

Decrease in severity of panic attacks as documented in panic dairy (only for participants with panic attacks)

Time frame: Week 8