Obsessive Compulsive DisorderNCT02202915
CBT for Pediatric OCD: Community Training Pilot
A study testing Behavioral Checklist in people with Obsessive Compulsive Disorder, run by Rhode Island Hospital at 1 site in United States.
Trial summary
This study examines a training program for clinicians who work in mental health clinics that serve children with OCD. We will provide clinician training in conducting exposure-based treatments for children with OCD. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Behavioral Checklist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to May 2018
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Obsessive Compulsive Disorder is primary diagnosis
Who cannot join
- Diagnosis of Psychosis, Pervasive Developmental Disorder, or Mental Retardation
Trial locations and contacts
1 site in 1 country.
United States1 site
Bradley Hospital
East Providence, Rhode Island, 02915
About this study
This study examines a training program for clinicians who work in mental health clinics that serve children with OCD. We will provide clinician training in conducting exposure-based treatments for children with OCD. The purpose of the project is to test the use of a new tool to enhance training in exposure-based treatments for clinicians. Therapists will receive training and oversight from the researchers regarding the treatment procedures and use of the new tool. All children enrolled in the study will receive treatment by clinicians who are participating in this study. Therapists and youth will be recruited separately for the study and will be assigned to work together.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Behavioral Checklist
- 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.
Behavioral ChecklistBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Fidelity Checklist Arm | Experimental | Therapists are receiving training using the fidelity Checklist Receives: Behavioral: Behavioral Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed therapist behaviors
We will us the Exposure Process Coding System to identify behaviors that therapists used during the exposures
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Benito, Ph.D., Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02202915
- Sponsor's protocol ID
- 4R33MH096828-03
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2014
- Last updated
- 12 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT for Pediatric OCD: Community Training Pilot
- ClinicalTrials.gov ID
- NCT02202915
- Acronym / sponsor ID
- 4R33MH096828-03
- Conditions
- Obsessive Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Mar 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 29 Jul 2014 (estimated)
- 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 examines a training program for clinicians who work in mental health clinics that serve children with OCD. We will provide clinician training in conducting exposure-based treatments for children with OCD. The purpose of the project is to test the use of a new tool to enhance training in exposure-based treatments for clinicians. Therapists will receive training and oversight from the researchers regarding the treatment procedures and use of the new tool. All children enrolled in the study will receive treatment by clinicians who are participating in this study. Therapists and youth will be recruited separately for the study and will be assigned to work together.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fidelity Checklist Arm | Experimental | Behavioral: Behavioral ChecklistTherapists are receiving training using the fidelity Checklist |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Obsessive Compulsive Disorder is primary diagnosis
Key exclusion criteria (1 listed)
- Diagnosis of Psychosis, Pervasive Developmental Disorder, or Mental Retardation
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 |
|---|---|---|
| Behavioral Checklist | Behavioural | Fidelity Checklist Arm |
Primary outcome
Observed therapist behaviors
Time frame: 9 months
We will us the Exposure Process Coding System to identify behaviors that therapists used during the exposures
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 12 Jul 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Checklist in people with Obsessive Compulsive Disorder, run by Rhode Island Hospital at 1 site 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 1 inclusion and 1 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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Observed therapist behaviors (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2019.