Family-Based Prevention Program for Childhood Anxiety

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Golda S. Ginsburg, Ph.D., Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00078728
First received: March 5, 2004
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Anxiety Disorders
Behavioral: Family-Based Anxiety Prevention Program
Behavioral: Evaluation only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Family-Based Prevention for Childhood Anxiety

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Child Anxiety Diagnosis [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.

  • Child Anxiety Diagnoses [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: September 2003
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00078728

Locations
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Golda S. Ginsburg, PhD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Golda S. Ginsburg, Ph.D., Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00078728     History of Changes
Other Study ID Numbers: K23 MH63427, K23MH063427
Study First Received: March 5, 2004
Results First Received: October 24, 2013
Last Updated: March 18, 2014
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014