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Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children

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ClinicalTrials.gov Identifier: NCT03584945
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : May 13, 2019
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Kate D. Fitzgerald, University of Michigan

Tracking Information
First Submitted Date  ICMJE June 29, 2018
First Posted Date  ICMJE July 12, 2018
Last Update Posted Date May 13, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task [ Time Frame: approximately 15-20 minutes ]
  • Child Yale-Brown Obsessive Compulsive Scale [ Time Frame: approximately 1 hour ]
    Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) is scored on a scale of 0 to 40, with 40 being the most severe.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03584945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2018)
  • Blood oxygen-level dependent (BOLD) functional connectivity MRI of task control circuits [ Time Frame: approximately 10 minutes ]
  • Diffusion tensor imaging (fractional anisotropy, FA) in task control circuit regions [ Time Frame: approximately 10 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
Official Title  ICMJE Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
Brief Summary This study will use magnetic resonance imaging (MRI) to assess the function and structure of overlapping task control circuits in children with a range of Obsessive-Compulsive symptoms (OCS). The functioning of task control circuits will be assessed using the well-validated Multisource interference task (MSIT). This study will also assess functional and anatomical connectivity within task control circuits in the same children, and determine whether disturbances in these overlapping circuits are associated with Obsessive-Compulsive Disorder (OCD) symptom severity. Behavioral measures will be administered to further assess regulatory, learning and memory functions. Children with OCD will then be offered a standard course of cognitive behavioral therapy (CBT) before rescanning (along with age-and gender-matched control participants) in order to assess how these circuits may change with treatment. Children with subclinical OC symptoms will be offered referral for treatment on an as-needed basis. In addition, de-identified data may be used in the future to conduct secondary data analyses. As more about OC symptoms and neurobiological mechanisms of interest in the current study are understood, data may be used to answer questions beyond those described in this protocol. All study procedures will be conducted on-site at Columbia University/the New York State Psychiatric Institute (New York, NY) and the University of Michigan's outpatient Child and Adolescent Psychiatry (Ann Arbor, Michigan).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Children ages 7-12 with OCD, obsessive compulsive symptoms, or healthy controls
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-compulsive Disorders and Symptoms in Children
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Therapy
    The treatment team will offer a course of cognitive behavioral therapy (CBT) (45 minute sessions for 12 to 16 weeks), augmented by medication treatment when clinically indicated based on the clinical treatment standards. Cognitive-behavioral therapy (CBT) is a treatment based on learning and cognitive theories. CBT for Obsessive-Compulsive Disorder (OCD) involves gradually exposing patients to anxiety provoking stimuli while having patients refrain from engaging in compulsive rituals and/or avoidance behaviors. There are three major components of CBT treatment for OCD, specifically: (1) exposure to anxiety provoking stimuli, (2) response prevention, and (3) cognitive techniques intended to decrease anxiety during the exposure and response prevention processes.
  • Other: Community Referral as appropriate
    Participants with Obsessive Compulsive Symptoms will be referred to the community for treatment
Study Arms  ICMJE
  • Experimental: Obsessive Compulsive Disorder
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • Subclinical Obsessive-Compulsive symptoms (OCS)
    Intervention: Other: Community Referral as appropriate
  • No Intervention: Healthy 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 29, 2018)
180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Obsessive-Compulsive Disorder (OCD) patient group

INCLUSION:

  1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) Diagnosis of OCD as the principal problem
  2. Not on psychotropic medication and not receiving current psychotherapy for OCD
  3. Written informed assent by the participants and consent by the parent
  4. Participants and a parent/guardian must be able to read and understand English

EXCLUSION

  1. DSM-V current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, or substance/alcohol abuse
  2. DSM-V lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
  3. Active suicidal ideation
  4. Females who are pregnant or nursing
  5. Major medical or neurological problems
  6. Presence of metallic device or dental braces
  7. Intelligence Quotient (IQ)<80
  8. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
  9. Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
  10. Individuals who have received a full course of CBT in the past
  11. A positive pregnancy test
  12. Positive urine screen for illicit drugs

Healthy controls

INCLUSION:

  1. Written informed assent by the participants and consent by the parent
  2. Participants and a parent/guardian must be able to read and understand English

EXCLUSION:

  1. Any current or lifetime psychiatric diagnosis
  2. Active suicidal ideation
  3. Females who are pregnant or nursing
  4. Major medical or neurological problems
  5. Presence of metallic device or dental braces
  6. IQ <80
  7. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
  8. A positive pregnancy test
  9. Positive urine screen for illicit drugs

Obsessive Compulsive Symptoms

INCLUSION:

  1. Presence of obsession(s) and/or compulsion(s) but no current or past history of OCD
  2. Not on psychotropic medication and not receiving current psychotherapy for OCD
  3. Written informed assent by the participants and consent by the parent
  4. Participants and a parent/guardian must be able to read and understand English

EXCLUSION:

  1. DSM-V current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, Tourette's/Tic Disorder, or substance/alcohol abuse
  2. DSM-V lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
  3. Active suicidal ideation
  4. Females who are pregnant or nursing
  5. Major medical or neurological problems
  6. Presence of metallic device or dental braces
  7. IQ<80
  8. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
  9. Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
  10. Individuals who have received a full course of CBT in the past
  11. Positive urine screen for illicit drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jennifer Nidetz, MSW 734-232-0293 jkgreene@med.umich.edu
Contact: Lana Khamash, BA 646-774-5868 lana.khamash@nyspi.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03584945
Other Study ID Numbers  ICMJE HUM00144074
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Participant data will be shared between sites at the University of Michigan and Columbia. A DUA will also be established per University guidelines as required. Coded, de-identified IPD will be shared with the NIMH data repository, RDoCdb.
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Responsible Party Kate D. Fitzgerald, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Columbia University
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP