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Completed

NCT Number: NCT00847561

Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children

This study will test the effectiveness of a family-based, cognitive behavioral therapy (CBT)-based program for preventing anxiety disorders in at-risk children.

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Key information

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

About this study

Anxiety disorders are among the most common mental disorders in children and adolescents, and they are associated with short- and long-term impairment in social, academic, familial, and psychological functioning. The children of parents with anxiety disorders are more likely to develop anxiety disorders themselves, because of genetic factors and the atmosphere in which they are raised. Previous research indicates that the risk of anxiety disorders among children can be reduced through preventive therapeutic interventions. In children with anxiety disorders whose parents also have anxiety disorders, therapy that includes their family is more successful than therapy focused only on the child. This study will test the effectiveness of a preventive, family-based therapy for children whose parents have anxiety disorders.

Participation in this study will last 1 year. First, interested participants will be asked to perform a screening assessment. This will include providing information about the symptoms, behaviors, and functioning of parent and child participants; filling out questionnaires; and videotaping the child and parent participants interacting. If, after the screening, participants are selected to continue with the study, they will be randomly assigned to receive either information monitoring or family-based cognitive behavioral therapy. Child and parent participants assigned to information monitoring will receive a booklet with information on coping with anxiety. Child and parent participants assigned to family-based cognitive behavioral therapy will meet with a study clinician for eight, weekly, 1-hour intervention visits, during which participants will learn skills to reduce anxiety. After completing the weekly visits, participants in this group will also receive three monthly booster sessions, in which coping skills will be reviewed. In addition to the screening visit, all participants will undergo identical assessments at three more time periods: 9 weeks, 6 months, and 12 months after entering the study. All participants will also receive monthly phone calls throughout the study to monitor the children's anxiety symptoms.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Parents of child participant have a current, primary anxiety disorder

Exclusion criteria

  • Child has an anxiety disorder or is currently in treatment for anxiety

Treatment and study plan

Family-based CBT

Behavioral

Eight, 1-hour weekly sessions with a trained clinician.

Information Monitoring

Behavioral

Packet providing information on strategies for coping with anxiety

Primary outcomes

  1. 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

    The C/P-ADIS is a semi-structured diagnostic interview used to assess symptoms of anxiety, depression, and behavioral issues.

    This interview will be administered by a trained staff member and will utilize information from both parents and children.

    This interview will be used to determine the presence or absence of an anxiety disorder for children in this study.

    .

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
2008
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2009
Registry last updated
Mar 24, 2017

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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