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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Golda S. Ginsburg, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00847561
First received: February 18, 2009
Last updated: May 5, 2014
Last verified: May 2014

February 18, 2009
May 5, 2014
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 ] [ Designated as safety issue: No ]

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.

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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 ]
Complete list of historical versions of study NCT00847561 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
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
Both
7 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00847561
R01 MH077312, R01MH077312, R01MH077312-01, DDTR B4-TBI
Yes
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
May 2014

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