30 Participants Needed

Personalized Assessments for Childhood OCD

LB
AC
Overseen ByAlexandra Chang
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

You can participate if you are not taking any medications or if you have been on a stable dose of your current medication for at least 8 weeks before joining the study.

What data supports the effectiveness of the treatment Exposure with Response Prevention (ERP) for childhood OCD?

Research shows that ERP, a type of therapy where children face their fears without performing their usual rituals, is effective in reducing OCD symptoms in children. Studies highlight the importance of family involvement and suggest that combining ERP with parent management training can enhance its effectiveness, especially in children with additional disruptive behaviors.12345

Is Exposure with Response Prevention (ERP) safe for treating OCD in children?

ERP is generally considered safe for treating OCD in children, though it can be distressing, which sometimes leads to treatment dropout. Studies emphasize the importance of family involvement and addressing specific challenges to improve treatment success.23467

How is the treatment Exposure with Response Prevention (ERP) unique for childhood OCD?

Exposure with Response Prevention (ERP) is unique for childhood OCD because it involves facing fears (exposure) without performing compulsive behaviors (response prevention), and it often includes family involvement to reduce family accommodation of OCD behaviors, which is not typically emphasized in other treatments.23489

Research Team

JF

Joseph F. McGuire, PhD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for children and teens aged 8-17 with a primary diagnosis of OCD, as confirmed by an interview. They should have moderate OCD severity and be either medication-free or on a stable dose for at least 8 weeks. Participants must speak English but can't join if they're already in psychotherapy for OCD, have certain other mental health conditions, or are at immediate risk of harming themselves.

Inclusion Criteria

I am between 8 and 17 years old.
I have been officially diagnosed with OCD.
Have moderate OCD severity as evidenced by a CY-BOCS total score of ≥16
See 2 more

Exclusion Criteria

I am currently receiving therapy for OCD.
I cannot fill out forms or go to appointments by myself.
Presence of psychotic disorder, bipolar disorder, or autism spectrum disorders
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 sessions of exposure with response prevention (ERP) guided by either standard practice or personalized assessments

12 weeks
12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Exposure with Response Prevention
Trial OverviewThe study is testing whether using mobile tech to assess OCD symptoms in kids leads to better treatment outcomes. It compares personalized cognitive-behavioral therapy (CBT), tailored based on these assessments, against standard CBT typically used to treat youth with OCD.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Personalized AssessmentsExperimental Treatment1 Intervention
12 sessions of exposure with response prevention (ERP) that is guided by personalized assessments.
Group II: Standard of CareActive Control1 Intervention
12 sessions of exposure with response prevention (ERP) that is guided using standard practice.

Exposure with Response Prevention is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Exposure with Response Prevention for:
  • Obsessive-Compulsive Disorder (OCD)
🇪🇺
Approved in European Union as Exposure with Response Prevention for:
  • Obsessive-Compulsive Disorder (OCD)
🇨🇦
Approved in Canada as Exposure with Response Prevention for:
  • Obsessive-Compulsive Disorder (OCD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Findings from Research

In a study involving six children aged 9-14 with OCD and disruptive behavior, combining parent management training (PMT) with exposure and response prevention (ERP) led to a 39% reduction in OCD symptoms, compared to a 10% reduction in those receiving ERP alone.
The findings suggest that addressing disruptive behavior through PMT before ERP can enhance treatment outcomes for children with OCD, indicating a potential strategy for improving therapy effectiveness.
Exposure and response prevention with or without parent management training for children with obsessive-compulsive disorder complicated by disruptive behavior: a multiple-baseline across-responses design study.Sukhodolsky, DG., Gorman, BS., Scahill, L., et al.[2018]
A survey of 107 clinicians revealed that most commonly use exposure with response prevention (ERP) for treating pediatric OCD, with clinical psychologists showing the highest rates of use.
Clinicians reported significant barriers to implementing ERP, particularly for treating hoarding and taboo obsessions, highlighting the need for targeted training to address these specific challenges in OCD therapy.
Clinician-reported barriers to using exposure with response prevention in the treatment of paediatric obsessive-compulsive disorder.Keleher, J., Jassi, A., Krebs, G.[2021]
Engaging both children and their caregivers in exposure and response-prevention (ERP) is essential for effectively treating obsessive-compulsive disorder (OCD) in young children.
The paper discusses strategies to overcome common challenges, such as parenting behaviors that may hinder treatment and the child's motivation, to improve the implementation of ERP.
Engaging Preschool and Early Elementary School-Aged Children in Exposure and Response Prevention (ERP).Metcalfe, RE., Pental, P., Duke, DC.[2022]

References

Exposure and response prevention with or without parent management training for children with obsessive-compulsive disorder complicated by disruptive behavior: a multiple-baseline across-responses design study. [2018]
Clinician-reported barriers to using exposure with response prevention in the treatment of paediatric obsessive-compulsive disorder. [2021]
Engaging Preschool and Early Elementary School-Aged Children in Exposure and Response Prevention (ERP). [2022]
Using Family-Based Exposure With Response Prevention to Treat Obsessive-Compulsive Disorder in Young Children: A Case Study. [2018]
[Intensive, short-term treatment for adolescents with persevering obsessive-compulsive disorder: three case-reports]. [2020]
Stepped care versus standard cognitive-behavioral therapy for obsessive-compulsive disorder: a preliminary study of efficacy and costs. [2021]
A meta-analysis of dropout rates from exposure with response prevention and pharmacological treatment for youth with obsessive compulsive disorder. [2022]
Exposure and response prevention process predicts treatment outcome in youth with OCD. [2022]
Family-based exposure and response prevention therapy for preschool-aged children with obsessive-compulsive disorder: a pilot randomized controlled trial. [2022]