- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01447966
Family Based Cognitive-Behavioral Treatment for Preschoolers With Obsessive Compulsive Disorder
March 24, 2014 updated by: Adam Lewin, University of South Florida
The purpose of this research study is to further investigate how well cognitive-behavioral psychotherapy works to reduce obsessive-compulsive symptoms in young children with obsessive-compulsive disorder (OCD).
Cognitive-behavioral therapy has been shown to work well in youth with OCD and other anxiety disorders; however, there are only a few studies to date in preschool and young children with OCD.
All children will have the option to receive 12 twice-weekly cognitive-behavioral psychotherapy sessions that are up to 60-minutes each.
Randomly determined, half of all children will receive these sessions immediately following the pre-assessment and the remaining half will receive them after six weeks.
The investigators expect that youth receiving the study-based therapy will show more improvement in OCD symptoms in six weeks in contrast to youth waiting to receive the therapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Cognitive Behavioral Therapy for OCD includes several core therapeutic elements including establishment of treatment goals, assigned homework, operant conditioning paradigms (the putative mechanism for exposure-based therapies), provision of psychoeducation (e.g., the link between thoughts, feelings, and behaviors), cognitive (e.g., cognitive restructuring) and behavioral (e.g., exposure) coping skill implementation, and target behavior progress assessments.
Nevertheless, research is lacking in preschoolers with OCD and these children likely require adaptations to the traditional CBT regimen.
Preschoolers often have a high level of family accommodation, whereby the family members become part of the rituals and compulsions in attempt to ease the young child's anxiety.
CBT with preschoolers will need to emphasize delivering intervention within the context of the family.
The flexibility of this modular approach for treatment (modular therapies allow for variations in the order and intensiveness of the aforementioned treatment elements, providing an individually tailored treatment instead of a one-size-fits-all approach) may be optimally suited for preschoolers with OCD given their wide variability in developmental level and symptom presentation.
This is consistent with the NIH Roadmap Initiative which calls for personalized interventions matched to individual patient characteristics.
Our OCD research team in the Rothman Center is highly experienced in clinical research for pediatric and adult OCD.
The proposed investigation is a single-site controlled trial of CBT in preschool aged youth with OCD aged 3-8 years.
We will randomly assign patients to immediate treatment or 6-week Treatment as Usual (TAU) control.
A manualized CBT protocol will be followed.
Assessments will occur at Screening, Baseline, Post-treatment and 1 and 3-month follow-ups.
Ratings of patient OCD symptom severity will be conducted at each time point by trained raters blinded to treatment condition.
Diagnosis will be established by an experienced clinician and verified by a validated rating scale conducted with the child's parent(s); cases will be reviewed by study investigators.
Assessments will be audio-recorded and verified for integrity.
Randomization will be determined immediately following the baseline assessment; patients will be assigned TAU or immediate treatment in a 1:1 ratio.
All eligible patients will receive 12 therapy sessions over 6 weeks using the evidence-based treatment protocol that incorporates E/RP and parent involvement; sessions are twice weekly for 60 minutes.
Dr. Lewin and other trained OCD therapists under his supervision will conduct therapy sessions.
All sessions are audiorecorded for integrity.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
St. Petersburg, Florida, United States, 33701
- University of South Florida - Rothman Center for Neuropsychiatry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Meets DSM-IV-TR for a primary diagnosis of OCD
- Minimum score of 8 on the CYBOCS compulsion scale
- Peabody Picture Vocabulary IV score of 80
- Able to attend biweekly appointments with a parent/guardian
- English Speaking
Exclusion Criteria:
- Current clinically significant suicidality
- engaged in suicidal behaviors within 6 months
- Peabody Picture Vocabulary IV score of 80
- Any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 4 weeks before study enrollment, any change in antipsychotics within 3 weeks prior to the screening assessment, any change in Prozac or Straterra within 6 weeks of study enrollment, and any change in alpha-2 agonists or stimulants within 1 week of study enrollment.
- Lifetime DSM-IV bipolar, schizophrenia or schizoaffective disorders; or Substance abuse in past 6 months.
- Absence of language
- Formal diagnosis of mental retardation or an autism spectrum disorder
- Unwillingness of parents to make the commitment to accompany their child for multiple study visits, unwillingness to take part in randomization, inability to attend sessions twice weekly as therapist availability allows, inability to attend assessment visits.
- Presence of a significant and/or unstable medical illness which might lead to hospitalization during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Treatment as Usual
Participants randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions).
Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored.
Thus, treatment will continue as it would in standard practice.
|
|
Experimental: Immediate CBT
Therapists will work with families for 12 twice weekly sessions, each lasting up to 60 minutes implementing a developmentally appropriate modulated cognitive behavioral therapy approach.
A manualized CBT protocol will be followed.
|
Family based cognitive behavioral therapy with exposure and response prevention.
Twice weekly for 45-60 minute visits.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinician Global Impression - Improvement Scale (Measure of patient improvement at relevent timepoints)
Time Frame: Baseline/Post-treatment or Post-waitlist/1 and 3 Month Follow-up
|
The CGI is a 7-point rating of treatment response anchored by 1 ("very much improved), 4 ("no change") and 7 ("very much worse").
Youth being rated by the IE as 1 ("very much improved") and 2 ("much improved") will be considered treatment responders.
This measure assesses change or improvement across time and consequently is appropriate for use at multiple assessments - reflects patient improvement relative to baseline functioning.
Represents change in functioning and assesses change in baseline.
Appropriate for use at multiple time-points.
|
Baseline/Post-treatment or Post-waitlist/1 and 3 Month Follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CYBOCS - Childrens Yale Brown Obsessive Compulsive Scale
Time Frame: Baseline, post-treatment/post waitlist, 1 and 3 month followup
|
The CY-BOCS is a 10-item semi-structured measure of obsession and compulsion severity over the previous week. Measure will be administered to the parent. Change score (calculated as a percent change from baseline) will be used as the outcome measure. |
Baseline, post-treatment/post waitlist, 1 and 3 month followup
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Adam B Lewin, Ph.D., University of South Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
March 1, 2014
Study Registration Dates
First Submitted
September 29, 2011
First Submitted That Met QC Criteria
October 5, 2011
First Posted (Estimate)
October 6, 2011
Study Record Updates
Last Update Posted (Estimate)
March 26, 2014
Last Update Submitted That Met QC Criteria
March 24, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YC-OCD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obsessive Compulsive Disorder (OCD)
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)RecruitingObsessive Compulsive Disorder (OCD)United States
-
University of ArizonaActive, not recruitingObsessive-compulsive Disorder (OCD)United States
-
University of LeipzigGerman Research Foundation; Philipps University Marburg Medical CenterCompleted
-
New York State Psychiatric InstituteCompletedObsessive-Compulsive Disorder (OCD)United States
-
Baylor College of MedicineBrown University; Duke University; University of Washington; Mclean Hospital; William... and other collaboratorsNot yet recruitingObsessive-Compulsive Disorder (OCD)United States
-
New York State Psychiatric InstituteCompletedObsessive Compulsive Disorder (OCD)United States
-
The University of Texas Health Science Center,...MedtronicRecruitingObsessive-Compulsive Disorder (OCD)United States
-
Haukeland University HospitalSorlandet Hospital HFActive, not recruitingObsessive Compulsive Disorder (OCD)
-
University of BathSouth London and Maudsley NHS Foundation Trust; Avon and Wiltshire Mental Health...UnknownObsessive Compulsive Disorder (OCD)United Kingdom
-
Assistance Publique - Hôpitaux de ParisRecruitingObsessive Compulsive Disorder OCDFrance
Clinical Trials on Cognitive Behavioral Therapy
-
Eleos HealthMissouri Department of Mental HealthCompletedMood Disorders | Anxiety DisordersUnited States
-
Regionsenter for barn og unges psykiske helseThe Research Council of NorwayCompletedGeneralized Anxiety Disorder | Social Phobia | Separation Anxiety DisorderNorway
-
Claremont McKenna CollegeUniversity of California, Los AngelesCompleted
-
University of South FloridaObsessive Compulsive FoundationCompletedObsessive Compulsive Disorder | Stepped Care Cognitive Behavioral TherapyUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)Completed
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedDepression | Sleep | Stress Disorders, Post-TraumaticUnited States
-
University of PittsburghWithdrawnPsychosis | Prodromal Symptoms | Prodromal Stage | Prodromal StatesUnited States
-
Duke UniversityCompleted
-
The University of Texas Health Science Center at...59th Medical Wing; Brooke Army Medical Center; South Texas Veterans Health Care...CompletedCombat Disorders | Post-Traumatic Stress Disorders | Stress DisordersUnited States
-
University of PittsburghCompletedDepression | Anxiety | Sickle Cell DiseaseUnited States