Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children

This study is currently recruiting participants.
Verified April 2012 by National Institute of Mental Health (NIMH)
Sponsor:
Information provided by (Responsible Party):
Golda Ginsburg, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00847561
First received: February 18, 2009
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Anxiety Disorders
Behavioral: Brief family-based cognitive behavioral therapy
Behavioral: Information

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Family-Based Prevention for Childhood Anxiety

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV) [ Time Frame: Measured pre- and post-treatment and after 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2008
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive family-based cognitive behavioral therapy.
Behavioral: Brief family-based cognitive behavioral therapy
Eight 1-hour weekly sessions with a clinician
Placebo Comparator: 2
Participants will receive information and monitoring.
Behavioral: Information
Booklet on strategies for coping with anxiety

Detailed Description:

Anxiety disorders are among the most common mental disorders in children and adolescents, and they are associated with short- and long-term impairment in social, academic, familial, and psychological functioning. The children of parents with anxiety disorders are more likely to develop anxiety disorders themselves, because of genetic factors and the atmosphere in which they are raised. Previous research indicates that the risk of anxiety disorders among children can be reduced through preventive therapy. In children with anxiety disorders whose parents also have anxiety disorders, therapy that includes their family is more successful than therapy focused only on the child. This study will test the effectiveness of a preventive, family-based therapy for children whose parents have anxiety disorders.

Participation in this study will last 1 year. First, participants will be asked to perform a screening assessment. This will include providing information about the symptoms, behaviors, and functioning of parent and child participants; filling out questionnaires; and videotaping the child and parent participants interacting. If, after the screening, participants are selected to continue with the study, they will be randomly assigned to receive either information monitoring or family-based cognitive behavioral therapy. Child and parent participants assigned to information monitoring will receive a booklet with information on coping with anxiety. Child and parent participants assigned to family-based cognitive behavioral therapy will meet with a study clinician for eight weekly 1-hour intervention visits, during which participants will learn skills to reduce anxiety. After completing the weekly visits, participants in this group will also receive three monthly booster sessions, in which coping skills will be reviewed. In addition to the screening visit, all participants will undergo identical assessments at three more time periods: 9 weeks after entering the study and 6 and 12 months after entering the study. All participants will also receive monthly phone calls throughout the study to monitor the children's anxiety symptoms.

  Eligibility

Ages Eligible for Study:   7 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents of child participant have an anxiety disorder

Exclusion Criteria:

  • Child has an anxiety disorder or is currently in treatment for anxiety
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847561

Contacts
Contact: Golda S. Ginsburg, PhD 410-955-1544 gginsbu@jhmi.edu
Contact: Rebekah Teetsel, MA 443-287-4349

Locations
United States, Maryland
Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21287
Contact: Golda S. Ginsburg, PhD     410-955-1544     gginsbu@jhmi.edu    
Principal Investigator: Golda S. Ginsburg, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Golda S. Ginsburg, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Golda Ginsburg, Professor, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00847561     History of Changes
Other Study ID Numbers: R01 MH077312, R01 MH077312-01, DDTR B4-TBI
Study First Received: February 18, 2009
Last Updated: April 25, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 26, 2012