Family-Based Prevention Program for Childhood Anxiety

Johns Hopkins University40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Anxiety Disorders

Interventions

Family-Based Anxiety Prevention ProgramBEHAVIORAL

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 onlyBEHAVIORAL

Participants will undergo evaluations without active treatment for 8 weeks.

Eligibility

Sex: ALLMin age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Number of Children With Child Anxiety Diagnosis

Measured by the Anxiety Disorder Interview Schedule for the Diagnostic and Statistical Manual of Mental Disorders 4th edition, child and parent versions.

Time frame: 12 month

Child Anxiety Diagnoses

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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