OCDNCT02866422
Development of an Instrument That Monitors Behaviors Associated With OCD
An observational study of OCD, run by University of Minnesota at 1 site in United States.
Trial summary
To support the discovery of new means for revealing the presence of Obsessive Compulsive Disorder (OCD), facilitating detection through new technology-based metrics, and attempt to automate existing diagnostic procedures allowing for more efficient diagnostic methods that would broaden clinical scope and outreach. Read more about this study
- Who is it for?
- Ages 5 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- OCD
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2015
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child
Study population: The investigators will recruit 20 children and adolescents with OCD aged 5-17 who present to the University of Minnesota Child and Adolescent Anxiety and Mood Disorders Clinic or who are referred from outside clinicians. Twenty healthy controls will be recruited from the community.
Who may be able to join
- Male and female children
- Aged 5 to 17
Who cannot join
- Inability or unwillingness to provide written informed consent/assent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
To support the discovery of new means for revealing the presence of Obsessive Compulsive Disorder (OCD), facilitating detection through new technology-based metrics, and attempt to automate existing diagnostic procedures allowing for more efficient diagnostic methods that would broaden clinical scope and outreach.
Read the detailed description
Aim 1: To observe and compare childhood behaviors regarding handwashing in OCD and control populations
Hypothesis 1: Control participants will spend less time washing their hands, will wash them less frequently, and will be less preoccupied with the sink when doing other activities.
Aim 2: To observe and compare childhood behaviors regarding organizing a cluttered area.
Hypothesis 2: OCD participants will be more disturbed by the presence of clutter and more compelled to organize the items than control participants
Aim 3: To observe and compare childhood behaviors regarding turning on/off light switches
Hypothesis 3: OCD children will be more likely to exhibit compulsive repetitive behaviors regarding the light switch than control participants
- Conditions
- OCD
- Being tested
- No Intervention
- Keywords
- OCD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Observational Study: No intervention
| Study group | Role | What they receive |
|---|---|---|
| OCD | Not described Receives: Other: No Intervention | |
| Healthy Controls | Not described Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Handwashing
Researchers blindly rate the how long (secs) it takes participants to wash their hands.
Measured: Same Day
Behaviors Associated with Handwashing
Researchers blindly rate whether participants exhibit any unique behavior while washing their hands.
Measured: Same Day
Length of Free Arrangement
Researchers blindly rate how long it takes participants to freely organize a box of school supplies.
Measured: Same Day
Frequency of Movements During Free Arrangement
Researchers blindly rate how many times participants move an object while freely arranging a box of school supplies.
Measured: Same Day
Amount of Space Used During Free Arrangement
Researchers blindly rate how much space participants use while freely arranging a box of school supplies (small, medium, or large space).
Measured: Same Day
Length of Carpet Arrangement
Researchers blindly rate and compare how long (secs) it takes participants to arrange a box of school supplies on a plain versus patterned carpet.
Measured: Same Day
Frequency of Movements During Carpet Arrangement
Researchers blindly rate and compare how many times participants move an object while arranging a box of school supplies on a plain versus patterned carpet.
Measured: Same Day
Frequency of Adjustments During Carpet Arrangement
Researchers blindly rate and compare how many times participants adjust the positioning of an object while arranging a box of school supplies on a plain versus patterned carpet.
Measured: Same Day
Size of Arrangement According to Sample
Researchers blindly rate and compare how accurately participants replicate the size of the arrangement according to a sample picture (smaller than sample, approximate to sample, larger than sample) on a plain versus patterned carpet.
Measured: Same Day
Frequency of Checking the Sample
Researchers blindly rate and compare how many times participants check the sample picture of the arrangement while organizing a box of school supplies on a plain versus patterned carpet.
Measured: Same Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2015
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 OCDStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Gail A Bernstein, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866422
- Sponsor's protocol ID
- 1403M49006
- Other IDs
- CNS 1338042
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 15 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bernstein GA, Hadjiyanni T, Cullen KR, Robinson JW, Harris EC, Young AD, Fasching J, Walczak N, Lee S, Morellas V, Papanikolopoulos N. Use of Computer Vision Tools to Identify Behavioral Markers of Pediatric Obsessive-Compulsive Disorder: A Pilot Study. J Child Adolesc Psychopharmacol. 2017 Mar;27(2):140-147. doi: 10.1089/cap.2016.0067. Epub 2016 Nov 10.
PubMed 27830935
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Instrument That Monitors Behaviors Associated With OCD
- ClinicalTrials.gov ID
- NCT02866422
- Acronym / sponsor ID
- 1403M49006
- Conditions
- OCD
- Keywords
- OCD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 15 Aug 2016 (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.
To support the discovery of new means for revealing the presence of Obsessive Compulsive Disorder (OCD), facilitating detection through new technology-based metrics, and attempt to automate existing diagnostic procedures allowing for more efficient diagnostic methods that would broaden clinical scope and outreach.
Detailed description
Aim 1: To observe and compare childhood behaviors regarding handwashing in OCD and control populations
Hypothesis 1: Control participants will spend less time washing their hands, will wash them less frequently, and will be less preoccupied with the sink when doing other activities.
Aim 2: To observe and compare childhood behaviors regarding organizing a cluttered area.
Hypothesis 2: OCD participants will be more disturbed by the presence of clutter and more compelled to organize the items than control participants
Aim 3: To observe and compare childhood behaviors regarding turning on/off light switches
Hypothesis 3: OCD children will be more likely to exhibit compulsive repetitive behaviors regarding the light switch than control participants
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCD | – | Other: No Intervention |
| Healthy Controls | – | Other: No Intervention |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The investigators will recruit 20 children and adolescents with OCD aged 5-17 who present to the University of Minnesota Child and Adolescent Anxiety and Mood Disorders Clinic or who are referred from outside clinicians. Twenty healthy controls will be recruited from the community.
Key inclusion criteria (2 listed)
- Male and female children
- Aged 5 to 17
Key exclusion criteria (1 listed)
- Inability or unwillingness to provide written informed consent/assent
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 |
|---|---|---|
| No InterventionObservational Study: No intervention | Other | Healthy Controls, OCD |
Primary outcome
Length of Handwashing
Time frame: Same Day
Researchers blindly rate the how long (secs) it takes participants to wash their hands.
Behaviors Associated with Handwashing
Time frame: Same Day
Researchers blindly rate whether participants exhibit any unique behavior while washing their hands.
Length of Free Arrangement
Time frame: Same Day
Researchers blindly rate how long it takes participants to freely organize a box of school supplies.
Frequency of Movements During Free Arrangement
Time frame: Same Day
Researchers blindly rate how many times participants move an object while freely arranging a box of school supplies.
Amount of Space Used During Free Arrangement
Time frame: Same Day
Researchers blindly rate how much space participants use while freely arranging a box of school supplies (small, medium, or large space).
Length of Carpet Arrangement
Time frame: Same Day
Researchers blindly rate and compare how long (secs) it takes participants to arrange a box of school supplies on a plain versus patterned carpet.
Frequency of Movements During Carpet Arrangement
Time frame: Same Day
Researchers blindly rate and compare how many times participants move an object while arranging a box of school supplies on a plain versus patterned carpet.
Frequency of Adjustments During Carpet Arrangement
Time frame: Same Day
Researchers blindly rate and compare how many times participants adjust the positioning of an object while arranging a box of school supplies on a plain versus patterned carpet.
Size of Arrangement According to Sample
Time frame: Same Day
Researchers blindly rate and compare how accurately participants replicate the size of the arrangement according to a sample picture (smaller than sample, approximate to sample, larger than sample) on a plain versus patterned carpet.
Frequency of Checking the Sample
Time frame: Same Day
Researchers blindly rate and compare how many times participants check the sample picture of the arrangement while organizing a box of school supplies on a plain versus patterned carpet.
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 15 Aug 2016.
- Derived from this study: PubMed 27830935Bernstein GA, Hadjiyanni T, Cullen KR, Robinson JW, Harris EC, Young AD, Fasching J, Walczak N, Lee S, Morellas V, Papanikolopoulos N. Use of Computer Vision Tools to Identify Behavioral Markers of Pediatric Obsessive-Compulsive Disorder: A Pilot Study. J Child Adolesc Psychopharmacol. 2017 Mar;27(2):140-147. doi: 10.1089/cap.2016.0067. Epub 2016 Nov 10.
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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.
Gail A Bernstein, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OCD, run by University of Minnesota 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 2 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 15 Aug 2016. 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?
Length of Handwashing (time frame: Same Day). The study lists 10 primary outcomes in all. 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 NCT02866422, 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 15 Aug 2016.