Computerized Cognitive Behavioral Therapy for Childhood Anxiety in Community Health Centers
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|ClinicalTrials.gov Identifier: NCT01416805|
Recruitment Status : Completed
First Posted : August 15, 2011
Results First Posted : June 18, 2019
Last Update Posted : June 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder Social Phobia Separation Anxiety Disorder||Behavioral: Computerized Cognitive Behavioral Therapy Behavioral: Treatment as usual||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Utilizing Health Information Technology to Improve Health Care Quality: Implementation of a Computerized Cognitive Behavioral Therapy Protocol for Childhood Anxiety|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
|Experimental: Computerized Cognitive Behavioral Therapy||
Behavioral: Computerized Cognitive Behavioral Therapy
Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
|Active Comparator: Treatment as Usual||
Behavioral: Treatment as usual
Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
- PARS [ Time Frame: 14 Weeks ]Pediatric Anxiety Rating Scale (PARS)- The PARS (RUPP, 2002) is a clinician-rated scale assessing anxiety symptoms and the associated severity and impairment in children over the past week. The scale score ranges from 0 to 30 with higher scores reflecting worse anxiety. The score, ranging from 0-30 represents a total score by summing all 6 items (which have item response options ranking from 0 to 5 each).
- ADIS-C/P Clinical Severity Rating [ Time Frame: 14 weeks ]Anxiety Disorders Interview Schedule for DSM-IV: Child and Parent Versions (ADIS-IV-C/P)- The ADIS-IV-C/P (Silverman & Albano, 1996) is a clinician-administered, semi-structured interview that assesses for the presence and severity of DSM-IV anxiety disorders as well as Dysthymia and Major Depression, ADHD, Conduct Disorder, and Oppositional-Defiant Disorder. Excellent psychometric properties have been reported (e.g., Wood et al., 2002). The Clinical Severity Rating score is a one item metric reflecting the severity of the anxiety diagnosis. This is rated by the clinician based on their interview with the patient and parent, together with their judgment. The Rating ranges from 0 to 8 with higher scores reflecting worse anxiety.
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): NCT01416805
|United States, Florida|
|Directions for Mental Health|
|Clearwater, Florida, United States|
|Henderson Behavioral Health|
|Fort Lauderdale, Florida, United States|
|Access Behavioral Health|
|Pensacola, Florida, United States|
|Tampa, Florida, United States, 33629|
|Principal Investigator:||Eric A Storch, Ph.D.||University of South Florida|