Early Intervention for Children at Risk for Anxiety

Anxiety Disorder Clinical Trial

Official title: Early Intervention for Children at Risk for Anxiety

Status Completed

Clinical Trial Summary

The aim of this study was to develop and pilot a cognitive-behavioral therapy (CBT) parent-child intervention for 4-7-year-old children at risk for anxiety disorders. The 20-session intervention was first piloted openly in 9 children (between 3/10/98 and 1/1/2001). The intervention was then tested in 65 children in a randomized controlled trial versus a monitoring-only wait-list control condition. Children had to either have an anxiety disorder, behavioral inhibition, or be the offspring of a parent with an anxiety disorder who had elevated symptoms of anxiety. In practice all children but one had at least one anxiety disorder at baseline. Children were blocked on presence or absence of parental anxiety disorder and randomized to the intervention or to a no-intervention wait-list control group. The intervention consisted of 6 parent-only sessions, 8-13 child-parent sessions, and a final parent session. Post-trial assessments were conducted at six months, and at one-year follow-up. The hypotheses were that the children assigned to the intervention group would show significantly better improvement (measured via Clinician Global Impression-Anxiety Improvement scale and absence of anxiety disorders) than children assigned to the wait-list condition.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders

• NCT number: NCT00865306
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Completed
• Phase: N/A
• Start date: March 1998
• Completion date: January 2005