Family-Based Prevention Program for Childhood Anxiety

Anxiety Disorders Clinical Trial

Official title:

Family-Based Prevention for Childhood Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00078728
• Other study ID #: K23MH063427
• Secondary ID: K23MH063427
• Status: Completed
• Phase: N/A
• First received: March 5, 2004
• Last updated: January 29, 2018
• Start date: September 2003
• Est. completion date: July 2007

Study information

• Verified date: January 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.

Description:

Anxiety disorders are serious conditions that can negatively impact a person's overall functioning. This study will enroll mothers with anxiety disorders and their children to determine whether a brief family-based intervention will reduce childhood anxiety better than standard care.

Participants will be randomly assigned to either the family-based prevention program or to evaluation only for 8 weeks. Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety. Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task will be used to assess participants. Assessments will be conducted at study start and one week after intervention completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after intervention completion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• Mothers with a current, primary anxiety disorder

• 7-12 year old children without an anxiety disorder

Exclusion Criteria:

• Mothers that do not have a current, primary anxiety disorder

• 7-12 year old children with an anxiety disorder

• 7-12 year old children that are currently receiving treatment for anxiety that could interfere with the study

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Family-Based Anxiety Prevention Program
Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks. The intervention will begin immediately after randomization to the study.
• Evaluation only
Participants will undergo evaluations without active treatment for 8 weeks.

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Children With Child Anxiety Diagnosis	Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.	12 month
Primary	Child Anxiety Diagnoses	The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.	12 months