Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

— SC-CBT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01981317
• Other study ID #: IOCDF2013
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: October 2018

Study information

• Verified date: October 2018
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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')

1. SC-CBT

Children who are randomized into SC-CBT will receive Step One:

• 3-in-office sessions - 1 hour each (over 6 weeks)

• 6 weekly phone calls (15 minutes or less)

• Post assessment (at the end of the 6 weeks)

• 3-month follow up

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:

• 9-in-office weekly sessions - 1 hour each (over 9 weeks)

• Post assessment (after session 9)

• 3-month follow up

OR

2. Standard CBT

Children who are randomized into the standard CBT group will receive:

• 12-in-office weekly sessions - 1 hour each (over 12 weeks)

• Midpoint Assessment (after 6 weeks)

• Post assessment (at the end of the 12 weeks)

• 3-month follow up

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion Criteria:

• Outpatient youth with obsessive-compulsive disorder between the ages 8-17 years.

• A Children's Yale-Brown Obsessive-Compulsive Scale score = 16

• Child has a Full Scale IQ = 80 as assessed on the WASI

• English speaking

Exclusion Criteria:

• Past adequate CBT with E/RP trial

• Initiation of antidepressant medication within 12 weeks before study enrollment, or an antipsychotic/mood stabilizer medication 6 weeks before study enrollment, or a stimulant/anxiolytic or alpha 2 agonist 4 weeks before study enrollment

• Established Treatment changes: Any change in dose of an established psychotropic medication (e.g., antidepressants) within 8 weeks before study enrollment (4 weeks for antipsychotic, mood stabilizer, alpha 2 agonist; 2 weeks for stimulant/anxiolytic). Alternative medications must be stable for 4 weeks prior to baseline. Any medications must remain stable during treatment; downward adjustments due to side effects may be acceptable with PI approval.

• Active child suicidality assessed by all available information (e.g., KSADS-PL, CDI).

• DSM-IV conduct disorder, autism, mental retardation, bipolar, schizophrenia/schizoaffective disorders; or substance abuse in past 6 months; or co-primary eating disorder; using all available information.

• Another behavioral/emotional problem or psychiatric disorder is considered to be more problematic than OCD.

• Non-English speaking.

• WASI-IQ SS <80.

Related Conditions & MeSH terms

• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder
• Stepped Care Cognitive Behavioral Therapy

Intervention

Behavioral:
• Stepped Care Cognitive Behavioral Therapy

• Cognitive Behavioral Therapy

Locations

Country	Name	City	State
United States	The Rothman Center for Pediatric Neuropsychiatry	Saint Petersburg	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	Obsessive Compulsive Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Clinical Global Impression Improvement Scale	The CGI-I is a widely used 7-point clinician rating of clinical improvement.	12 weeks
Secondary	Clinical Global Impression Severity Scale	The CGI-S is a widely used 7-point clinician rating of clinical severity.	12 weeks