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. Identifier: NCT00847561
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : June 3, 2014
Last Update Posted : March 24, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Golda S. Ginsburg, Ph.D., Johns Hopkins University

February 18, 2009
February 19, 2009
May 5, 2014
June 3, 2014
March 24, 2017
August 2008
May 2014   (Final data collection date for primary outcome measure)
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.

Anxiety Disorders Interview Schedule for DSM-IV (ADIS-IV) [ Time Frame: Measured pre- and post-treatment and after 6 and 12 months ]
Complete list of historical versions of study NCT00847561 on Archive Site
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Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children
Family-Based Prevention for Childhood Anxiety
This study will test the effectiveness of a family-based, cognitive behavioral therapy (CBT)-based program for preventing anxiety disorders in at-risk children.

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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Anxiety Disorders
  • Behavioral: Family-based CBT
    Eight, 1-hour weekly sessions with a trained clinician.
  • Behavioral: Information Monitoring
    Packet providing information on strategies for coping with anxiety
  • 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.
    Intervention: Behavioral: Family-based CBT
  • 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.
    Intervention: Behavioral: Information Monitoring
Ginsburg GS, Drake KL, Tein JY, Teetsel R, Riddle MA. Preventing Onset of Anxiety Disorders in Offspring of Anxious Parents: A Randomized Controlled Trial of a Family-Based Intervention. Am J Psychiatry. 2015 Dec;172(12):1207-14. doi: 10.1176/appi.ajp.2015.14091178. Epub 2015 Sep 25.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2014
May 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 13 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
R01MH077312( U.S. NIH Grant/Contract )
R01MH077312 ( U.S. NIH Grant/Contract )
R01MH077312-01 ( U.S. NIH Grant/Contract )
DDTR B4-TBI ( Other Identifier: )
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Golda S. Ginsburg, Ph.D., Johns Hopkins University
Johns Hopkins University
National Institute of Mental Health (NIMH)
Principal Investigator: Golda S. Ginsburg, PhD Johns Hopkins University
Johns Hopkins University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP