Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder

Tracking Information
First Submitted Date ICMJE	April 14, 2009
First Posted Date ICMJE	April 15, 2009
Results First Submitted Date	April 7, 2015
Results First Posted Date	May 15, 2015
Last Update Posted Date	June 11, 2015
Study Start Date ICMJE	March 2009
Actual Primary Completion Date	June 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: May 14, 2015)	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. [ Time Frame: within one week after treatment condition was concluded ]; Items on this scale are summed to arrive at a total score. Scores on this scale range from 0 to 40 with higher scores corresponding to worse symptom severity.
Original Primary Outcome Measures ICMJE; (submitted: April 14, 2009)	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. [ Time Frame: Screening, Baseline, Post-treatment, Follow-up at 3 months ]
Change History	Complete list of historical versions of study NCT00881465 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: May 15, 2015)	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. [ Time Frame: within one week after treatment condition was concluded ]Scores on this scale range from 0 to 6 with higher scores corresponding to worse symptom severity.; 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"). [ Time Frame: within one week after treatment condition was concluded ]Scores on this scale range from 1 to 7. Scores of 1 (very much improved) and 2 (much improved) are grouped together to indicate if a participate has had a beneficial response to the interview. The data represents participants who had a beneficial response to the treatment condition. Scores of 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) and 7 (very much worse) are grouped together to indicate that a participant has not had a positive treatment response.
Original Secondary Outcome Measures ICMJE; (submitted: April 14, 2009)	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. [ Time Frame: Screening, Baseline, Post-treatment, 3-month follow-up ]; 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"). [ Time Frame: Post-treatment, Follow-up ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Official Title ICMJE	Videophone Administered Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Brief 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.
Detailed Description	Although cognitive-behavioral therapy (CBT) is the most effective intervention for pediatric obsessive-compulsive disorder (OCD), many people do receive CBT initially due, in part, to the lack of trained providers and geographic barriers (e.g., distance to such providers). Rather, the majority of youth with OCD receive psychiatric medication alone or together with unproven forms of psychotherapy. While some serotonergic medications have demonstrated utility in pediatric OCD, side effects can be common, response rates are modest at best, and symptom remission is rare. Given this, alternative ways of providing CBT need to be identified and tested to increase the number of people with access to this form of treatment. 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. Cognitive-behavioral therapy will be based on a demonstrated effective treatment protocol, and adapted for videophone administration. Comprehensive assessments will be conducted by trained clinicians at relevant time-points (e.g., baseline, post-treatment, follow-up) to assess symptom severity and impairment. Should supporting data be found, videophone-administered CBT would have the potential to help many more families who would otherwise remain untreated or inadequately treated. On a societal level, evaluation and dissemination of telehealth interventions such as this will lessen costs related to sustained treatment and OCD related impairment.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Obsessive Compulsive Disorder
Intervention ICMJE	Behavioral: Cognitive-behavioral therapy Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks.; Behavioral: Wait-list control Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.
Study Arms	Experimental: Cognitive-behavioral therapy Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth. Intervention: Behavioral: Cognitive-behavioral therapy; Placebo Comparator: Waitlist Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment. Intervention: Behavioral: Wait-list control
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: May 14, 2015)	31
Original Estimated Enrollment ICMJE; (submitted: April 14, 2009)	30
Actual Study Completion Date	June 2010
Actual Primary Completion Date	June 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	7 Years to 17 Years (Child)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00881465
Other Study ID Numbers ICMJE	USF-09-0155
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Eric Storch, Ph.D., University of South Florida
Study Sponsor ICMJE	University of South Florida
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Eric Storch, Ph.D. University of South Florida
PRS Account	University of South Florida
Verification Date	May 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP