Clinical trial NCT01981317: Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Stepped Care Cognitive Behavioral Therapy
Keywords: Obsessive Compulsive Disorder
Cognitive Behavioral Therapy
Stepped Care CBT
Exposure and Response Prevention
Psychotherapy
Counseling
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Obsessive Compulsive Foundation
First posted: 2013-11-11
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Children's Yale-Brown Obsessive-Compulsive Scale
timeFrame: 12 weeks
measure: Clinical Global Impression Improvement Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical Global Impression Severity Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: The Rothman Center for Pediatric Neuropsychiatry
state: Florida
Study officials:
affiliation: University of South Florida
name: Adam Lewin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: