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Completed

NCT Number: NCT00078728

Family-Based Prevention Program for Childhood Anxiety

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

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Family-Based Anxiety Prevention Program

Behavioral

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.

Evaluation only

Behavioral

Participants will undergo evaluations without active treatment for 8 weeks.

Primary outcomes

  1. Number of Children With 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Family-Based Prevention for Childhood Anxiety

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Mar 8, 2004
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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