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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00847561
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : June 3, 2014
Last Update Posted : March 24, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Golda S. Ginsburg, Ph.D., Johns Hopkins University

Study Description
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Brief Summary:
This study will test the effectiveness of a family-based, cognitive behavioral therapy (CBT)-based program for preventing anxiety disorders in at-risk children.

Condition or disease Intervention/treatment Phase
Anxiety Disorders Behavioral: Family-based CBT Behavioral: Information Monitoring Not Applicable

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 therapeutic interventions. 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, interested 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, 6 months, 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Family-Based Prevention for Childhood Anxiety
Study Start Date : August 2008
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Family-based CBT
Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.
 Behavioral: Family-based CBT
Eight, 1-hour weekly sessions with a trained clinician.
Placebo Comparator: Information Monitoring
Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.
 Behavioral: Information Monitoring
Packet providing information on strategies for coping with anxiety


Outcome Measures
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Primary Outcome Measures :
  1. Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS) [ Time Frame: 12 months post-treatment ]

    The C/P-ADIS is a semi-structured diagnostic interview used to assess symptoms of anxiety, depression, and behavioral issues.

    This interview will be administered by a trained staff member and will utilize information from both parents and children.

    This interview will be used to determine the presence or absence of an anxiety disorder for children in this study.

    .



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Parents of child participant have a current, primary anxiety disorder

Exclusion Criteria:

  • Child has an anxiety disorder or is currently in treatment for anxiety
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847561


Locations
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United States, Maryland
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Golda S. Ginsburg, PhD Johns Hopkins University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Golda S. Ginsburg, Ph.D., Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00847561    
Other Study ID Numbers: R01MH077312 ( U.S. NIH Grant/Contract )
R01MH077312 ( U.S. NIH Grant/Contract )
R01MH077312-01 ( U.S. NIH Grant/Contract )
DDTR B4-TBI ( Other Identifier: ClinicalTrials.gov )
First Posted: February 19, 2009    Key Record Dates
Results First Posted: June 3, 2014
Last Update Posted: March 24, 2017
Last Verified: March 2017
Keywords provided by Golda S. Ginsburg, Ph.D., Johns Hopkins University:
Anxiety
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders