Obsessive-compulsive Disorders and Symptoms in ChildrenNCT03584945
Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
A study testing Cognitive Behavioral Therapy and Community Referral as appropriate in people with Obsessive-compulsive Disorders and Symptoms in Children, run by University of Michigan at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Obsessive-compulsive Disorders and Symptoms in Children
- What is being tested?
- Cognitive Behavioral Therapy and Community Referral as appropriate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Mar 2019to 3 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
- Written informed assent by the participants and consent by the parent
- Participants and a parent/guardian must be able to read and understand English
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 35Show fewer
- 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
- 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
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
New York State Psychiatric Institute
New York, New York, 10032
About this study
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).
Read the detailed description
Recruitment is complete. U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume analysis of results from its two sites for results reporting after OHRP and the IRB has approved the resumption of research.
- Being tested
- Cognitive Behavioral Therapy, Community Referral as appropriate
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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.
Community Referral as appropriateOther
Participants with Obsessive Compulsive Symptoms will be referred to the community for treatment
| Study group | Role | What they receive |
|---|---|---|
| Obsessive Compulsive Disorder | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy |
| Subclinical Obsessive-Compulsive symptoms (OCS) | Other | Not described Receives: Other: Community Referral as appropriate |
| Healthy Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task
Measured: up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups); approximately 15-20 minutes
Secondary outcomes (3)
Blood oxygen-level dependent (BOLD) functional connectivity MRI of task control circuits
Measured: up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 10 minutes
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.
Measured: up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 1 hour
Obsessive Compulsive Inventory - Child Version (OCI-CV)
Self-report assessment of obsessive compulsive symptoms, non-clinical to clinical range.
Measured: baseline assessment of all participants (OCD, subclinical OCS and HC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start24 Mar 2019
- Primary completion3 Jun 2023
- Study completion3 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obsessive-compulsive Disorders and Symptoms in ChildrenStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Children ages 6-14 with OCD, obsessive compulsive symptoms, or healthy controls
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kate D. Fitzgerald, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584945
- Sponsor's protocol ID
- HUM00144074
- Other IDs
- 1R01MH114958-01A1, R01MH115024-01A1
- Status last verified
- Feb 2025
- First submitted
- 29 Jun 2018
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 35485920
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
- ClinicalTrials.gov ID
- NCT03584945
- Acronym / sponsor ID
- HUM00144074
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Columbia University, National Institute of Mental Health (NIMH)
- Study start
- 24 Mar 2019 (actual)
- Primary completion
- 3 Jun 2023 (actual)
- Study completion
- 3 Jun 2023 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume analysis of results from its two sites for results reporting after OHRP and the IRB has approved the resumption of research.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Children ages 6-14 with OCD, obsessive compulsive symptoms, or healthy controls
| Arm | Type | Receives |
|---|---|---|
| Obsessive Compulsive Disorder | Experimental | Behavioral: Cognitive Behavioral Therapy |
| Subclinical Obsessive-Compulsive symptoms (OCS) | Other | Other: Community Referral as appropriate |
| Healthy Control | No intervention | – |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
- Written informed assent by the participants and consent by the parent
Key exclusion criteria (35 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyThe 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. | Behavioural | Obsessive Compulsive Disorder |
| Community Referral as appropriateParticipants with Obsessive Compulsive Symptoms will be referred to the community for treatment | Other | Subclinical Obsessive-Compulsive symptoms (OCS) |
Primary outcome
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
3 secondary outcomes
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
Child Yale-Brown Obsessive Compulsive Scale
Time frame: up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 1 hour
Obsessive Compulsive Inventory - Child Version (OCI-CV)
Time frame: baseline assessment of all participants (OCD, subclinical OCS and HC)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 35485920Wang 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Community Referral as appropriate in people with Obsessive-compulsive Disorders and Symptoms in Children, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.