Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Results First Received: May 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Anxiety Disorders
Interventions: Behavioral: Family-based CBT
Behavioral: Information Monitoring

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Family-based CBT

Family-based Cognitive Behavioral Therapy (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.

Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician.

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.

Information Monitoring: Packet providing information on strategies for coping with anxiety


Participant Flow:   Overall Study
    Family-based CBT     Information Monitoring  
STARTED     70     66  
COMPLETED     57     62  
NOT COMPLETED     13     4  
Withdrawal by Subject                 4                 3  
Unable to schedule                 9                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician.

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.

Information Monitoring: Packet providing information on strategies for coping with anxiety

Total Total of all reporting groups

Baseline Measures
    Family-based CBT     Information Monitoring     Total  
Number of Participants  
[units: participants]
  70     66     136  
Age  
[units: years]
Mean ± Standard Deviation
  8.53  ± 7.76     8.86  ± 1.85     8.69  ± 1.80  
Gender  
[units: participants]
     
Female     44     32     76  
Male     26     34     60  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     58     57     115  
other ethnicity/race     12     9     21  
Region of Enrollment  
[units: participants]
     
United States     70     66     136  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Golda Ginsburg
Organization: The Johns Hopkins University School of Medicine
phone: 410-955-1544
e-mail: gginsbu@jhmi.edu


No publications provided


Responsible Party: Golda S. Ginsburg, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00847561     History of Changes
Other Study ID Numbers: R01 MH077312, R01MH077312, R01MH077312-01, DDTR B4-TBI
Study First Received: February 18, 2009
Results First Received: May 5, 2014
Last Updated: May 5, 2014
Health Authority: United States: Federal Government