Stepped Care Cognitive Behavioral Therapy for Pediatric Obsessive Compulsive Disorder
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 8 - 17 |
| Updated: | 3/22/2019 |
| Start Date: | October 2013 |
| End Date: | October 2018 |
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.
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')
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
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
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.
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