Family-Based Prevention for Childhood Anxiety
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of Children With Child Anxiety Diagnosis
Study Overview
Brief Summary
This study will evaluate the effectiveness of a short-term family-based program for preventing anxiety disorders in at-risk children.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 7 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Family-based anxiety prevention program
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.
Intervention: Family-Based Anxiety Prevention Program (Behavioral)
Evaluation only
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.
Intervention: Evaluation only (Behavioral)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported