Family-Based Prevention Program for Childhood Anxiety
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|ClinicalTrials.gov Identifier: NCT00078728|
Recruitment Status : Completed
First Posted : March 8, 2004
Results First Posted : December 16, 2013
Last Update Posted : February 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders||Behavioral: Family-Based Anxiety Prevention Program Behavioral: Evaluation only||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Family-Based Prevention for Childhood Anxiety|
|Study Start Date :||September 2003|
|Actual Primary Completion Date :||July 2007|
|Actual Study Completion Date :||July 2007|
Experimental: 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.
Behavioral: Family-Based Anxiety Prevention Program
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.
Active Comparator: 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.
Behavioral: Evaluation only
Participants will undergo evaluations without active treatment for 8 weeks.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00078728
|United States, Maryland|
|Johns Hopkins University School of Medicine|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator:||Golda S. Ginsburg, PhD||Johns Hopkins University|