Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder

NCT01981317 | Completed

• 1 other identifier: IOCDF2013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Clinical Global Impression Severity Scale

  12 weeks

Study Arms (2)

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.

Behavioral: Stepped Care Cognitive Behavioral Therapy

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.

Behavioral: Cognitive Behavioral Therapy

Interventions

Stepped Care Cognitive Behavioral Therapy BEHAVIORAL

Stepped Care CBT

Cognitive Behavioral Therapy BEHAVIORAL

Standard CBT

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• Obsessive Compulsive Foundation: collaborator

Study Sites (1)

The Rothman Center for Pediatric Neuropsychiatry

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Adam Lewin, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: November 11, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: October 1, 2018
• Last Updated: March 20, 2019

Record last verified: 2018-10

Locations

US (1)