Phase 2
N=31
Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Obsessive Compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00881465 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). The CY-BOCS is a 10-item Semi-structured Measure of Obsession and Compulsion Severity Over the Previous Week. This Measure Will Serve as the Primary Outcome Index. — 11.13; 18.53 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cognitive-behavioral therapy (Behavioral); Wait-list control (Behavioral)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- University of South Florida
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997). The CY-BOCS is a 10-item Semi-structured Measure of Obsession and Compulsion Severity Over the Previous Week. This Measure Will Serve as the Primary Outcome Index. |
11.13; 18.53 | — |
| SECONDARY Clinical Global Impression - Severity (CGI-S; National Institute of Mental Health, 1985). The CGI-S is a 7-point Clinician Rating of Severity of Psychopathology. |
1.56; 2.47 | — |
| SECONDARY Clinical Global Improvement (CGI; Guy, 1976). The CGI is a 7-point Rating of Treatment Response Anchored by 1 ("Very Much Improved) and 7 ("Very Much Worse"). |
13; 2 | — |
Summary
Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric obsessive-compulsive disorder (OCD), many people do receive CBT initially. Given this, alternative ways of providing CBT need to be identified and tested. With this in mind, the proposed study examines the efficacy of a videophone based cognitive-behavioral intervention for youth with OCD. A total of 30 youth will be randomly assigned to either videophone administered CBT or an abbreviated wait-list control arm. Comprehensive assessments will be conducted by trained clinicians at relevant time-points to assess symptom severity and impairment.
Eligibility Criteria
Inclusion Criteria
- Principal diagnosis of OCD on the ADIS-IV-C/P and CY-BOCS Total Score ≥ 16
- No change in psychotropic medication (if applicable) for at least 8 weeks prior to study entry
- 7 to 17 years old
- Availability of at least one parent to accompany the child to all assessment sessions and be present for videophone sessions
- Have a computer within their home
Exclusion Criteria
- History of and/or current psychosis, autism, bipolar disorder, or current suicidality
- Principal diagnosis other than OCD
- A positive diagnosis in the caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit their ability to understand CBT (based on clinical interview)
- The child requires a higher level of psychiatric and/or medical care (e.g., inpatient hospitalization)
- Child receptive vocabulary < 80.
Data sourced from ClinicalTrials.gov (NCT00881465). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.