Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
Primary Purpose
Obsessive-compulsive Disorders and Symptoms in Children
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Community Referral as appropriate
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-compulsive Disorders and Symptoms in Children
Eligibility Criteria
Obsessive-Compulsive Disorder (OCD) patient group
INCLUSION:
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnosis of OCD as the principal problem
- Not on psychotropic medication and not receiving current psychotherapy for OCD
- Written informed assent by the participants and consent by the parent
- Participants and a parent/guardian must be able to read and understand English
EXCLUSION
- DSM-5 current diagnosis of major depressive disorder, or substance/alcohol abuse
- DSM-5 lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
- Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications (stable doses of stimulants or other types of ADHD medications - e.g. Guanfacine - are allowable for OCD subjects with comorbid attention deficit hyperactivity disorder following investigator review of medication; on day of study scan, subjects must be willing to refrain from taking medication until after scan is completed)
- Active suicidal ideation
- Females who are pregnant or nursing
- Major medical or neurological problems
- Presence of metallic device or dental braces
- Intelligence Quotient (IQ)<80
- A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
- Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
- Individuals who have received a full course of CBT in the past
- A positive pregnancy test
- Positive urine screen for illicit drugs
Healthy controls
INCLUSION:
- Written informed assent by the participants and consent by the parent
- Participants and a parent/guardian must be able to read and understand English
EXCLUSION:
- Any current or lifetime psychiatric diagnosis
- Active suicidal ideation
- Females who are pregnant or nursing
- Major medical or neurological problems
- Presence of metallic device or dental braces
- IQ <80
- A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
- A positive pregnancy test
- Positive urine screen for illicit drugs
Obsessive Compulsive Symptoms
INCLUSION:
- Presence of obsession(s) and/or compulsion(s) but no current diagnosis of OCD (i.e.,<1 hour/day, no more than mild interference or distress)
- Not on psychotropic medication and not receiving current psychotherapy for OCD
- Written informed assent by the participants and consent by the parent
- Participants and a parent/guardian must be able to read and understand English
EXCLUSION:
- DSM-5 current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, Tourette's/Tic Disorder, or substance/alcohol abuse
- DSM-5 lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
- Active suicidal ideation
- Females who are pregnant or nursing
- Major medical or neurological problems
- Presence of metallic device or dental braces
- IQ<80
- A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
- Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
- Individuals who have received a full course of CBT in the past
- Positive urine screen for illicit drugs
Sites / Locations
- University of Michigan
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Other
No Intervention
Arm Label
Obsessive Compulsive Disorder
Subclinical Obsessive-Compulsive symptoms (OCS)
Healthy Control
Arm Description
Outcomes
Primary Outcome Measures
Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task
Secondary Outcome Measures
Blood oxygen-level dependent (BOLD) functional connectivity MRI of task control circuits
Child Yale-Brown Obsessive Compulsive Scale
Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) is scored on a scale of 0 to 40, with 40 being the most severe.
Obsessive Compulsive Inventory - Child Version (OCI-CV)
Self-report assessment of obsessive compulsive symptoms, non-clinical to clinical range.
Full Information
NCT ID
NCT03584945
First Posted
June 29, 2018
Last Updated
August 11, 2023
Sponsor
University of Michigan
Collaborators
Columbia University, National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT03584945
Brief Title
Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
Official Title
Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2019 (Actual)
Primary Completion Date
June 3, 2023 (Actual)
Study Completion Date
June 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Columbia University, National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 up to 12 cognitive behavioral therapy (CBT), either via remote video conference sessions or in person visits when clinically indicated, before scanning (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
Recruitment is complete.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorders and Symptoms in Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Children ages 6-14 with OCD, obsessive compulsive symptoms, or healthy controls
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obsessive Compulsive Disorder
Arm Type
Experimental
Arm Title
Subclinical Obsessive-Compulsive symptoms (OCS)
Arm Type
Other
Arm Title
Healthy Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
The treatment team will offer a course of up to 12 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. Due to Covid, therapy sessions are offered via remote video conference (in clinic sessions made available if clinically indicated). 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.
Intervention Type
Other
Intervention Name(s)
Community Referral as appropriate
Intervention Description
Participants with Obsessive Compulsive Symptoms will be referred to the community for treatment
Primary Outcome Measure Information:
Title
Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task
Time Frame
up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups); approximately 15-20 minutes
Secondary Outcome Measure Information:
Title
Blood oxygen-level dependent (BOLD) functional connectivity MRI of task control circuits
Time Frame
up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 10 minutes
Title
Child Yale-Brown Obsessive Compulsive Scale
Description
Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) is scored on a scale of 0 to 40, with 40 being the most severe.
Time Frame
up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 1 hour
Title
Obsessive Compulsive Inventory - Child Version (OCI-CV)
Description
Self-report assessment of obsessive compulsive symptoms, non-clinical to clinical range.
Time Frame
baseline assessment of all participants (OCD, subclinical OCS and HC)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Obsessive-Compulsive Disorder (OCD) patient group
INCLUSION:
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnosis of OCD as the principal problem
Not on psychotropic medication and not receiving current psychotherapy for OCD
Written informed assent by the participants and consent by the parent
Participants and a parent/guardian must be able to read and understand English
EXCLUSION
DSM-5 current diagnosis of major depressive disorder, or substance/alcohol abuse
DSM-5 lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications (stable doses of stimulants or other types of ADHD medications - e.g. Guanfacine - are allowable for OCD subjects with comorbid attention deficit hyperactivity disorder following investigator review of medication; on day of study scan, subjects must be willing to refrain from taking medication until after scan is completed)
Active suicidal ideation
Females who are pregnant or nursing
Major medical or neurological problems
Presence of metallic device or dental braces
Intelligence Quotient (IQ)<80
A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
Individuals who have received a full course of CBT in the past
A positive pregnancy test
Positive urine screen for illicit drugs
Healthy controls
INCLUSION:
Written informed assent by the participants and consent by the parent
Participants and a parent/guardian must be able to read and understand English
EXCLUSION:
Any current or lifetime psychiatric diagnosis
Active suicidal ideation
Females who are pregnant or nursing
Major medical or neurological problems
Presence of metallic device or dental braces
IQ <80
A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
A positive pregnancy test
Positive urine screen for illicit drugs
Obsessive Compulsive Symptoms
INCLUSION:
Presence of obsession(s) and/or compulsion(s) but no current diagnosis of OCD (i.e.,<1 hour/day, no more than mild interference or distress)
Not on psychotropic medication and not receiving current psychotherapy for OCD
Written informed assent by the participants and consent by the parent
Participants and a parent/guardian must be able to read and understand English
EXCLUSION:
DSM-5 current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, Tourette's/Tic Disorder, or substance/alcohol abuse
DSM-5 lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
Active suicidal ideation
Females who are pregnant or nursing
Major medical or neurological problems
Presence of metallic device or dental braces
IQ<80
A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
Individuals who have received a full course of CBT in the past
Positive urine screen for illicit drugs
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
35485920
Citation
Wang Z, Fontaine M, Cyr M, Rynn MA, Simpson HB, Marsh R, Pagliaccio D. Subcortical shape in pediatric and adult obsessive-compulsive disorder. Depress Anxiety. 2022 Jun;39(6):504-514. doi: 10.1002/da.23261. Epub 2022 Apr 29.
Results Reference
derived
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Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
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