Family-Based Prevention Program for Childhood Anxiety - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00078728

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:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Family-Based Prevention for Childhood Anxiety

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Self- and parent-reports, diagnostic interviews, a computerized memory task, and a videotaped parent-child interaction task [ Time Frame: Measured pre- and post-treatment and at 6 and 12 month follow-up visits ] [ Designated as safety issue: No ]

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
1 Family-based prevention program: Experimental	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.
2 Evaluation only: Active Comparator	Behavioral: Evaluation only Participants will undergo evaluations without active treatment for 8 weeks.

Detailed Description:

Anxiety disorder is a serious condition 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 study completion (Week 9). Follow-up visits will be conducted at 6 and 12 months after study completion.

Eligibility

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

Criteria

Inclusion Criteria:

Mothers with anxiety disorder and their 7- to 12-year-old children

Contacts and Locations

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Golda S. Ginsburg, PhD

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Johns Hopkins School of Medicine ( Golda S. Ginsburg, PhD )
Study ID Numbers:	K23 MH63427, DDTR BK-TKPD
Study First Received:	March 5, 2004
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00078728 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Anxiety

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 22, 2009