The Rothman Center for Pediatric Neuropsychiatry
St. Petersburg, Florida, 33701, United States
NCT Number: NCT01981317
The purpose of this research study is to determine how well children with OCD can be helped using therapy that requires less clinic visits. The investigators are testing a Stepped-Care Cognitive Behavioral Therapy (SC-CBT) approach in which children receive a full course of parent-led, therapist-guided treatment for OCD. The goal is to see if therapy can be done in fewer visits to the clinic. Children receiving SC-CBT will start with Step One, which includes three therapy sessions over six weeks. Those who do not get better in Step One will "STEP UP" to Step Two which involves coming in to meet with a therapist for the remaining sessions. Youth receiving SC-CBT will be compared to youth receiving standard CBT in the clinic through this study. It is expected that Stepped Care will be an acceptable, cost-effect, and feasible treatment with outcomes similar to standard CBT.
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Notify Me8 year–17 year
All sexes
Interventional
Not applicable
St. Petersburg, Florida, 33701, United States
Below is a summary of assessment and interventions as part of the study (separated by condition). Two thirds will receive SC-CBT, one-third standard CBT (determined at random following the initial phone screen).
A. Phone Screen (with parent)
B. Informed Consent and Initial Assessment
C. Randomization to either SC-CBT or Standard CBT
D. Treatment Phase (either 1 or 2 determined at random following 'C')
Children who are randomized into SC-CBT will receive Step One:
Children are "stepped up" to Step Two of SC-CBT if we determine more therapy is needed (following the post assessment). Step Two is a continuation of therapy and will include:
OR
Children who are randomized into the standard CBT group will receive:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 weeks
The Children's Yale-Brown Obsessive-Compulsive Scale is a psychometrically sound clinician-rated interview assessing OCD symptom severity.
Time frame: 12 weeks
The CGI-I is a widely used 7-point clinician rating of clinical improvement.
Time frame: 12 weeks
The CGI-S is a widely used 7-point clinician rating of clinical severity.
University of South Florida
Other
Acronym: SC-CBT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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