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

Anxiety Disorders Clinical Trial

Official title:

Family-Based Prevention for Childhood Anxiety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847561
• Other study ID #: R01MH077312
• Secondary ID: R01MH077312R01MH
• Status: Completed
• Phase: N/A
• First received: February 18, 2009
• Last updated: March 23, 2017
• Start date: August 2008
• Est. completion date: May 2014

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Behavioral:
• Family-based CBT
Eight, 1-hour weekly sessions with a trained clinician.
• Information Monitoring
Packet providing information on strategies for coping with anxiety

Locations

Country	Name	City	State
United States	The Johns Hopkins University School of Medicine	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety Disorders Interview Schedule for Diagnostic and Statistical Manual for Psychological Disorders-IV, Child and Parent Versions (C/P-ADIS)	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.	12 months post-treatment

External Links

•   CAPS Website