Family-Based Prevention Program for Childhood Anxiety

Johns Hopkins University

Status: Completed

Conditions: Anxiety Disorders

Treatments: Behavioral: Evaluation only; Behavioral: Family-Based Anxiety Prevention Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00078728

K23MH063427 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Family-based anxiety prevention program

Experimental group

Description:

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.

Treatment:

Behavioral: Family-Based Anxiety Prevention Program

Evaluation only

Active Comparator group

Description:

Waitlist control group. Participants in this group will receive general information (in the form of a printed packet) about anxiety after randomization 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 accept will begin the prevention sessions and will receive the same CBT-based, family-based prevention program as the other treatment arm.

Treatment:

Behavioral: Evaluation only