Family-Based Prevention Program for Childhood Anxiety

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

Detailed Description
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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.

Official Title
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Family-Based Prevention for Childhood Anxiety

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Behavioral: Family-Based Anxiety Prevention Program
* Behavioral: Evaluation only


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family-based anxiety prevention program<br>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. | Behavioral: Family-Based Anxiety Prevention Program<br>* 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.<br>|
| Active Comparator: Evaluation only<br>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. | Behavioral: Evaluation only<br>* Participants will undergo evaluations without active treatment for 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety