Obsessive-Compulsive DisorderNCT06407648
Using Personalized Assessments in the Treatment of Childhood OCD
A study testing Personalized Assessments in people with Obsessive-Compulsive Disorder, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary purpose of this study is to learn whether personalized assessment of obsessive-compulsive disorder (OCD) symptoms in childhood OCD using mobile health technology are feasible and acceptable for youth and parents. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Personalized Assessments
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- be 8-17 years of age;
- meet diagnostic criteria for a primary diagnosis of OCD on a structured clinical interview;
- have moderate OCD severity as evidenced by a CY-BOCS total score of ≥16;
- medication free and/or on a stable dose of medication 8 weeks prior to study participation;
- be English speaking.
Who cannot join
- the presence of psychotic disorder, bipolar disorder, or autism spectrum disorders;
- significant suicidal ideation that warrants medical intervention;
- concurrent psychotherapy for OCD;
- inability to complete scales, or attend visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
About this study
The primary purpose of this study is to learn whether personalized assessment of obsessive-compulsive disorder (OCD) symptoms in childhood OCD using mobile health technology are feasible and acceptable for youth and parents. The investigators will also examine whether personalized cognitive-behavioral therapy (CBT) that is informed by personalized OCD assessments yields better clinical outcomes when compared to standard CBT for youth with OCD
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Personalized Assessments, Standard of Care
- Keywords
- children, adolescents, exposure with response prevention, cognitive behavioral therapy, ERP, CBT
- 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.
Personalized AssessmentsOther
Personalized CBT will use individualized OCD symptom networks to guide CBT strategies to target central symptom nodes in contemporaneous networks.
Standard of CareOther
The standard CBT condition will use standard-of-care approaches to guide CBT strategies to target OCD symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Assessments | Experimental | 12 sessions of exposure with response prevention (ERP) that is guided by personalized assessments. Receives: Other: Personalized Assessments |
| Standard of Care | Active comparator | 12 sessions of exposure with response prevention (ERP) that is guided using standard practice. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Yale-Brown Obsessive-Compulsive Scale Second Edition (CY-BOCS-II) Total Severity Score
A clinician-rated measure of OCD symptom severity in the past week. This 10-item measure is rated on a 0 to 5 scale with a total score ranging from 0 to 50. A higher total score is reflective of greater OCD symptom severity.
Measured: Screen, Baseline (Week 0), Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start3 Apr 2024
- Primary completion15 Sep 2026
- Study completion30 Dec 2026 (estimated)
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.
- More trials run by Johns Hopkins UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized parallel clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph F. McGuire, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407648
- Sponsor's protocol ID
- IRB00406231
- Status last verified
- Oct 2026
- First submitted
- 6 May 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Personalized Assessments in the Treatment of Childhood OCD
- ClinicalTrials.gov ID
- NCT06407648
- Acronym / sponsor ID
- IRB00406231
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- children, adolescents, exposure with response prevention, cognitive behavioral therapy, ERP, CBT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 15 Sep 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 May 2024 (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.
The primary purpose of this study is to learn whether personalized assessment of obsessive-compulsive disorder (OCD) symptoms in childhood OCD using mobile health technology are feasible and acceptable for youth and parents. The investigators will also examine whether personalized cognitive-behavioral therapy (CBT) that is informed by personalized OCD assessments yields better clinical outcomes when compared to standard CBT for youth with OCD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| Personalized Assessments | Experimental | Other: Personalized Assessments12 sessions of exposure with response prevention (ERP) that is guided by personalized assessments. |
| Standard of Care | Active comparator | Other: Standard of Care12 sessions of exposure with response prevention (ERP) that is guided using standard practice. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- be 8-17 years of age;
- meet diagnostic criteria for a primary diagnosis of OCD on a structured clinical interview;
- have moderate OCD severity as evidenced by a CY-BOCS total score of ≥16;
- medication free and/or on a stable dose of medication 8 weeks prior to study participation;
- be English speaking.
Key exclusion criteria (4 listed)
- the presence of psychotic disorder, bipolar disorder, or autism spectrum disorders;
- significant suicidal ideation that warrants medical intervention;
- concurrent psychotherapy for OCD;
- inability to complete scales, or attend visits.
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 |
|---|---|---|
| Personalized AssessmentsPersonalized CBT will use individualized OCD symptom networks to guide CBT strategies to target central symptom nodes in contemporaneous networks. | Other | Personalized Assessments |
| Standard of CareThe standard CBT condition will use standard-of-care approaches to guide CBT strategies to target OCD symptoms. | Other | Standard of Care |
Primary outcome
Children's Yale-Brown Obsessive-Compulsive Scale Second Edition (CY-BOCS-II) Total Severity Score
Time frame: Screen, Baseline (Week 0), Week 4, Week 8, and Week 12
A clinician-rated measure of OCD symptom severity in the past week. This 10-item measure is rated on a 0 to 5 scale with a total score ranging from 0 to 50. A higher total score is reflective of greater OCD symptom severity.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Joseph F. McGuire, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Assessments in people with Obsessive-Compulsive Disorder, run by Johns Hopkins University 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Children's Yale-Brown Obsessive-Compulsive Scale Second Edition (CY-BOCS-II) Total Severity Score (time frame: Screen, Baseline (Week 0), Week 4, Week 8, and Week 12). 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 9 Oct 2026.