Anxiety Disorders Clinical Trial
— SPACEOfficial title:
Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)
Verified date | March 2020 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Childhood anxiety disorders are very common, carry tremendous personal and societal costs, frequently do not respond adequately to treatment, and involving parents in treatment has so far not enhanced outcomes. Explanatory clinical trials are needed to identify parent specific mechanisms of change that are not targeted in direct child treatment, and to identify markers of who is most likely to benefit from parent intervention. This study is an explanatory clinical trial of a parent based intervention and of cognitive behavioral therapy, and an investigation of biological and behavioral moderators of treatment response.
Status | Completed |
Enrollment | 124 |
Est. completion date | November 2018 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 14 Years |
Eligibility |
Inclusion Criteria: Children: - meet criteria for a primary DSM5 anxiety disorder of generalized anxiety disorder (GAD), social phobia (SOP), and separation anxiety disorder (SAD) using the DSM-5 version of the Anxiety Disorders Interview Schedule -Child and Parent Versions (ADIS-C/P) - mean score of 4 or greater on the ADIS-C/P Clinician Rating Scale of Severity (CSR) - ceasing all other psychosocial treatment upon consultation with the clinic staff and the service provider - not using any psychotropic medication other than a stable dose of stimulant medication treatment for comorbid ADHD or a stable dose of Selective Serotonin Reuptake Inhibitor (SSRI) - children who are on a stable dose of stimulant medication or SSRI (i.e., a minimum of six weeks at the same dose) will be included so as not to limit generalizability. Exclusion Criteria: Children: - primary diagnosis of any Axis I DSM-IV disorder other than GAD, SOP, Phobias and SAD - any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive Developmental Disorders, Mental Retardation, Organic Mental Disorders, Bipolar Disorder, Schizophrenia and Other Psychotic Disorders - drug or alcohol abuse/dependence will also be exclusionary - tic disorders will not be exclusionary unless they require psychotropic medication to stabilize - Significant active suicidal ideation or a past suicide attempt in the last 6 months. Adolescents with a history of non-lethal self-harm behaviors (e.g., cutting) will be allowed to enroll if they meet other criteria - have an intellectual disability as reported by guardian - be a victim of past or present undisclosed abuse requiring investigation or ongoing supervision by the Department of Social Services - not have been cohabiting with mother for at least one year prior to admittance. Parent: - any of the following disorders (e.g., primary, secondary, tertiary) - Pervasive Developmental Disorders, Mental Retardation, Selective Mutism, Organic Mental Disorders, Bipolar Disorder, Schizophrenia and Other Psychotic Disorders. Drug or alcohol abuse/dependence will also be exclusionary - not have been cohabiting with child for at least one year prior to admittance - report the presence of any active suicidal ideation or a past suicide attempt in the last 6 months. |
Country | Name | City | State |
---|---|---|---|
United States | Yale University Child Study Center | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute of Mental Health (NIMH) |
United States,
Lebowitz ER, Woolston J, Bar-Haim Y, Calvocoressi L, Dauser C, Warnick E, Scahill L, Chakir AR, Shechner T, Hermes H, Vitulano LA, King RA, Leckman JF. Family accommodation in pediatric anxiety disorders. Depress Anxiety. 2013 Jan;30(1):47-54. doi: 10.1002/da.21998. Epub 2012 Sep 10. — View Citation
Lebowitz, E. R., Omer, H., Hermes, H., & Scahill, L. (2013). Parent Training for Childhood Anxiety Disorders: The SPACE Program. Cognitive and Behavioral Practice.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical Global Impression Scale Improvement and Severity | Clinician determined rating of illness | After 12 weeks of treatment | |
Primary | Pediatric Anxiety Rating Scale | Clinician administered rating of child anxiety | After 12 weeks of treatment | |
Secondary | Screen for Childhood Anxiety Related Disorders | A self and parent report of child anxiety | After 12 weeks of treatment |
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