Psychotherapy Research Treatment Study for Anxious Children and Teens

Purpose:

Psychotherapy research study for children and teens who suffer from anxiety. We are seeking children and adolescent patients for an open clinical trial of psychodynamic psychotherapy for pediatric patients with anxiety disorders. Patients are eligible to participate if they are between the ages of 8 and 15, if they carry the primary diagnosis of the anxiety disorders: separation anxiety disorder, generalized anxiety disorder, or social phobia, and if they do not have substance dependence, or psychosis. In order to participate, patients will have to discontinue all ongoing psychotherapeutic treatment throughout the course of the protocol.

Condition:

The primary diagnosis of the anxiety disorders: separation anxiety disorder, generalized anxiety disorder, or social phobia

Intervention:

Twice weekly psychodynamic psychotherapy

Study Type:

Open clinical trial

Study Design:

Study clinicians are senior clinicians with doctoral level degrees and over 15 years' experience in working with pediatric patients with anxiety disorders. Psychotherapy sessions will be twice weekly, extending for 19-24 sessions. Participants will be asked to undergo standard semi-structured interviews at the beginning of the study, and to fill out standard psychiatric rating instruments before entering the protocol, at treatment termination, and at six month follow-up. Treatment is free of charge.

Primary Outcome Measures:

Pediatric Anxiety Rating Scale (PARS)

Secondary Outcome Measures:

Clinical global Assessment Scale for Children (CGAS), Clinical Global Impression (CGI), Anxiety Disorders Interview Schedule for DSM-IV, PArent and Child Versions (ADIS-PC)

Enrollment:

Study Start Date:

4/22/2009

Primary Completion Date:

5/22/2012

Groups:

Open clinical trial of psychodynamic psychotherapy treatment group.

Assigned Interventions:

Twice-weekly psychodynamic psychotherapy (talk therapy focused on dynamic meaning behind anxiety symptoms).

Ages of Eligibility:

8-15

Gender:

Any

Inclusion Criteria:

Patients are eligible to participate if they are between the ages of 8 and 15, if they carry the primary diagnosis of the anxiety disorders: separation anxiety disorder, generalized anxiety disorder, or social phobia.

Exclusion Criteria:

Substance dependence, or psychosis are exclusionary criteria. In order to participate, patients will also have to discontinue all ongoing psychotherapeutic treatment throughout the course of the protocol.

Contacts:

This study is being run by Barbara Milrod, M.D. at Weill Cornell Medical College. If you know anyone who is interested in participating, please call Dr. Milrod at 212-746-5868.

Locations:

Weill Cornell Medical College

NY Presbyterian Hospital

525 East 68th Street

NY, NY 10065

Sponsors & Collaborators:

American Academy of Child and Adolescent Psychiatry

Investigators:

Barbara Milrod, M.D., Theodore Shapiro, M.D.

Responsible Party:

Weill Cornell Medical College

Study ID Numbers:

Protocol #: 0992010243

Health Authority:

WCMC IRB approved 02-08-2010 to 02-07-2011