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Family-Based Prevention Program for Childhood Anxiety

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: NCT00078728
Recruitment Status : Completed
First Posted : March 8, 2004
Results First Posted : December 16, 2013
Last Update Posted : April 14, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.

Condition or disease Intervention/treatment
Anxiety Disorders Behavioral: Family-Based Anxiety Prevention Program Behavioral: Evaluation only

Detailed Description:

Anxiety disorders are serious conditions that can negatively impact a person's overall functioning. This study will enroll mothers with anxiety disorders and their children to determine whether a brief family-based intervention will reduce childhood anxiety better than standard care.

Participants will be randomly assigned to either the family-based prevention program or to evaluation only for 8 weeks. Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety. Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task will be used to assess participants. Assessments will be conducted at study start and one week after intervention completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after intervention completion.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Family-Based Prevention for Childhood Anxiety
Study Start Date : September 2003
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Family-based anxiety prevention program
Participants will complete an 8 session (1 session/week), cognitive behavioral therapy-based, family prevention program to be administered by a trained clinician, after randomization to the study. The prevention program will include 3 booster sessions that take place after the first 8 sessions.
Behavioral: Family-Based Anxiety Prevention Program
Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks. The intervention will begin immediately after randomization to the study.
Active Comparator: Evaluation only
Waitlist control group. Participants in this group will receive general information (in the form of a printed packet) about anxiety after radomization to the study. Families in this group will complete all study evaluations and will then be offered the option of participating in the prevention program. Families who accpet will begin the prevention sessions and will receive the same CBT-based, family-based prevention program as the other treatment arm.
Behavioral: Evaluation only
Participants will undergo evaluations without active treatment for 8 weeks.

Outcome Measures

Primary Outcome Measures :
  1. Child Anxiety Diagnosis [ Time Frame: 12 month ]
    Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.

  2. Child Anxiety Diagnoses [ Time Frame: 12 months ]
    The cumulative number of children who developed an anxiety disorder at each assessment point during the study. Using the intent to treat sample, a total of 6 children in the non-intervention group developed an anxiety disorder by the 12-month assessment. No children in the CAPS group developed an anxiety disorder.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mothers with a current, primary anxiety disorder
  • 7-12 year old chidlren without an anxiety disorder

Exclusion Criteria:

  • Mothers that do not have a current, primary anxiety disorder
  • 7-12 year old childrne with an anxiety disorder
  • 7-12 year old children that are currently recieving treatment for anxiety that could interfere with the study
Contacts and Locations

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): NCT00078728

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

Responsible Party: Golda S. Ginsburg, Ph.D., Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00078728     History of Changes
Other Study ID Numbers: K23MH063427 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2004    Key Record Dates
Results First Posted: December 16, 2013
Last Update Posted: April 14, 2014
Last Verified: March 2014

Keywords provided by Golda S. Ginsburg, Ph.D., Johns Hopkins University:

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders