Status:
COMPLETED
Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Anxiety Disorders
Anxiety, Separation
Eligibility:
All Genders
7-14 years
Phase:
NA
Brief Summary
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...
Detailed Description
Despite strong evidence for the efficacy of individual cognitive-behavior therapy (ICBT) for childhood anxiety disorders, up to 50% of children remain symptomatic after treatment and many still meet d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT02310152
Start Date
November 1 2014
End Date
November 1 2018
Last Update
March 9 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University Child Study Center
New Haven, Connecticut, United States, 06519