search
Back to results

Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder (SC-CBT)

Primary Purpose

Obsessive Compulsive Disorder, Stepped Care Cognitive Behavioral Therapy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stepped Care Cognitive Behavioral Therapy
Cognitive Behavioral Therapy
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Obsessive Compulsive Disorder, Cognitive Behavioral Therapy, Stepped Care CBT, Exposure and Response Prevention, Psychotherapy, Counseling

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Rothman Center for Pediatric Neuropsychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepped Care CBT

Standard CBT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Clinical Global Impression Improvement Scale
The CGI-I is a widely used 7-point clinician rating of clinical improvement.

Secondary Outcome Measures

Clinical Global Impression Severity Scale
The CGI-S is a widely used 7-point clinician rating of clinical severity.

Full Information

First Posted
November 4, 2013
Last Updated
March 18, 2019
Sponsor
University of South Florida
Collaborators
Obsessive Compulsive Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT01981317
Brief Title
Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder
Acronym
SC-CBT
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
Obsessive Compulsive Foundation

4. Oversight

5. Study Description

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') 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder, Stepped Care Cognitive Behavioral Therapy
Keywords
Obsessive Compulsive Disorder, Cognitive Behavioral Therapy, Stepped Care CBT, Exposure and Response Prevention, Psychotherapy, Counseling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stepped Care CBT
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard CBT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stepped Care Cognitive Behavioral Therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Primary Outcome Measure Information:
Title
Children's Yale-Brown Obsessive-Compulsive Scale
Description
The Children's Yale-Brown Obsessive-Compulsive Scale is a psychometrically sound clinician-rated interview assessing OCD symptom severity.
Time Frame
12 weeks
Title
Clinical Global Impression Improvement Scale
Description
The CGI-I is a widely used 7-point clinician rating of clinical improvement.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical Global Impression Severity Scale
Description
The CGI-S is a widely used 7-point clinician rating of clinical severity.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Lewin, Ph.D.
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Rothman Center for Pediatric Neuropsychiatry
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder

We'll reach out to this number within 24 hrs