Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children
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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 |
- 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.
Ages Eligible for Study: | 7 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Parents of child participant have an anxiety disorder
Exclusion Criteria:
- Child has an anxiety disorder or is currently in treatment for anxiety
Contact: Golda S. Ginsburg, PhD | 410-955-1544 | gginsbu@jhmi.edu |
Contact: Rebekah Teetsel, MA | 443-287-4349 |
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 |
Principal Investigator: | Golda S. Ginsburg, PhD | Johns Hopkins University |
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