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| Name | Class |
|---|---|
| Obsessive Compulsive Foundation | OTHER |
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.
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')
SC-CBT
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
Standard CBT
Children who are randomized into the standard CBT group will receive:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stepped Care CBT | Experimental | All participants in this arm receive Step One which includes 3-in-office sessions lasting 1 hour each over 6 weeks and 6 weekly phone calls lasting 15 minutes or less. The in-office sessions are devoted to psychoeducation, cognitive therapy, and hierarchy development. These sessions will include all procedures of the standard therapist-delivered CBT but will be parent-led, therapist guided; thus, the parent is delivering evidence-based strategies with clinician guidance. Children are then "stepped up" to Step Two of SC-CBT if it is determined that more therapy is needed following the post assessment. Step Two is a continuation of therapy and will include 9 additional in-office weekly session lasting 1 hour each over 9 weeks. These sessions will be therapist-led and are devoted to exposure and response prevention. |
|
| Standard CBT | Active Comparator | All patients in this arm will receive 12 sessions of therapy over 12 weeks using the evidence-based cognitive behavioral therapy protocol in POTS (2004). Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-12 involve exposure and response prevention exercises specific to each youth. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stepped Care Cognitive Behavioral Therapy | Behavioral |
| ||
| Cognitive Behavioral Therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Children's Yale-Brown Obsessive-Compulsive Scale | The Children's Yale-Brown Obsessive-Compulsive Scale is a psychometrically sound clinician-rated interview assessing OCD symptom severity. | 12 weeks |
| Clinical Global Impression Improvement Scale | The CGI-I is a widely used 7-point clinician rating of clinical improvement. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression Severity Scale | The CGI-S is a widely used 7-point clinician rating of clinical severity. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Lewin, Ph.D. | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Rothman Center for Pediatric Neuropsychiatry | St. Petersburg | Florida | 33701 | United States |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Behavioral |
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