Explanatory Clinical Trial of a Novel Parent Intervention for Childhood Anxiety (SPACE)

Completed · Not applicable

Conditions studied: Anxiety Disorders, Anxiety, Separation, Phobic Disorders

In brief

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.

Key facts

Study ID

NCT02310152

Run by

Yale University

People needed

124

Starts

2014-11-01

Expected to finish

2018-11-01

Last updated by the study team

2020-03-09

Who can join

Age: 7 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale University Child Study Center — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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