The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-17
SponsorJohns Hopkins University
About this trial
This study will test the efficiency of the Freespira Breathing System in youth.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
SCARED score ≥ 25 + prior clinical diagnosis of an anxiety disorder
Participants must be 9-17 years of age
If on psychotropic medication(s), participant must be on a stable dose for at least one month prior to study enrollment
Disqualifiers
Anxiety has occurred exclusively during a major depressive episode, psychiatric illness, dementia, intellectual disability, or brain disease
Currently enrolled in another device or drug study or less than 30 days has elapsed since participation in such a study
Currently undergoing breathing biofeedback elsewhere
Demonstrate evidence of severe suicidal ideation or psychosis
Trial design
Design model
Crossover
Treatments tested in this trial
Freespira Breathing System
DeviceOver an 8-week period the efficacy of the FBS system in youth will be tested, with those in the randomized active device group. The control group will not receive the device until completion of the 8 week baseline.
Treatment groups
73 Participants
are divided into 2 treatment groupsGroup A: Device GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Screen for Child Anxiety Related Disorders (SCARED) 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
8-weeksSecondary outcomes
1
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
Baseline2
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
Week 4 Follow Up3
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
Week 8 Follow Up4
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
6-month Follow UpOther outcomes
1
Child Sheehan Disability Scale (CSDS)
The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).
Time frame
Baseline2
Child Sheehan Disability Scale (CSDS)
The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).
Time frame
Week 4 Follow Up3
Child Sheehan Disability Scale (CSDS)
The CSDS was designed to measure the extent to which the child's anxiety symptoms were interfering with daily functioning. The CSDS is an adaptation of the Sheehan Disability Scale and consisted of items inquiring about the degree to which the child's anxiety symptoms interfere with school, social, and family functioning. As on the SDS, items are measured on an 11-point Likert-type scale ranging from 0 (not at all) to 10 (very, very much) .The wording of the anchors on the SDS was adapted to be more appropriate for children. A parent version (CSDS-P) that included six items was also created. The CSDS-P included three items that assessed the degree to which the parents perceived the child's anxiety symptoms to be interfering with the child's functioning (school, social, family) as well as three items that assessed the degree to which the child's symptoms were viewed as interfering with the parent's functioning (work, social, family).
Time frame
Week 8 Follow Up4
Children's Depression Inventory ( CDI2)
The Children's Depression Inventory (CDI and CDI2) is a psychological assessment that rates the severity of symptoms related to depression or dysthymic disorder in children and adolescents. The CDI is a 27-item scale that is self-rated and symptom-oriented. The assessment is now in its second edition. The 27 items on the assessment are grouped into five major factor areas. Clients rate themselves based on how they feel and think, with each statement being identified with a rating from 0 to 2.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
Palo Alto Health Sciences, Inc.
Collaborator
Source ClinicalTrials.gov
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