Personalized Assessments for Childhood OCD

Overseen By Alexandra Chang

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Psychotic, Bipolar, Autism, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if mobile health technology can personalize assessments of OCD symptoms in children, thereby enhancing treatment effectiveness. It compares standard cognitive-behavioral therapy (CBT) with a personalized version tailored to each child's specific needs. Children and teens aged 8 to 17 with moderate OCD, who are not currently changing medications or receiving other therapy, might be suitable candidates for this trial. Participants will undergo 12 sessions of exposure with response prevention (ERP), a type of CBT. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve OCD treatment for children.

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 prior data suggests that personalized assessments for childhood OCD are safe?

Studies have shown that exposure with response prevention (ERP) is a safe and effective treatment for obsessive-compulsive disorder (OCD). Research indicates that ERP works well in both hospitals and outpatient clinics. Those who have undergone ERP often report fewer symptoms of depression and anxiety. ERP is recommended as the first-choice treatment for individuals with OCD. Although every treatment can have side effects, ERP has a strong safety record and is well-tolerated by most patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Personalized Assessments approach for treating childhood OCD because it tailors the therapy to each child's unique needs. Unlike the standard Exposure with Response Prevention (ERP) therapy, which follows a one-size-fits-all method, this new approach uses personalized assessments to guide the sessions. This customization could lead to more effective treatment outcomes by addressing the specific triggers and behaviors of each child. By adapting the therapy to fit individual profiles, researchers hope to improve the success rates and overall experience for young patients dealing with OCD.

What evidence suggests that personalized assessments could improve treatment for childhood OCD?

Research has shown that a method called Exposure with Response Prevention (ERP) can help reduce OCD symptoms in children. Studies have found that ERP not only lowers OCD symptoms but also alleviates related anxiety. Experts consider ERP a top treatment choice for children with OCD. In this trial, one group will receive standard ERP, while another group will receive ERP customized to fit each child's specific needs. This personalized approach aims to improve results by focusing on each child's unique symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Joseph F. McGuire, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Exposure with Response Prevention

Trial Overview The 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.

How Is the Trial Designed?

Group I: Personalized Assessments Experimental Treatment 1 Intervention

12 sessions of exposure with response prevention (ERP) that is guided by personalized assessments.

Group II: Standard of Care Active Control 1 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)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Exposure with response prevention (ERP) for youth with obsessive-compulsive disorder (OCD) has a low attrition rate of 10.24%, which is significantly lower than other treatment modalities like pharmacotherapy (17.29%) and active controls (20.63%).

The study suggests that ERP is an effective first-line treatment for OCD, as attrition is primarily due to logistical issues rather than treatment distress, indicating that concerns about distress leading to dropout are unfounded.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of dropout rates from exposure with response prevention and pharmacological treatment for youth with obsessive compulsive disorder. Johnco, C., McGuire, JF., Roper, T., et al.[2022]

Family-based exposure/response prevention therapy (E/RP) is highly effective for treating early onset obsessive-compulsive disorder (OCD) in very young children, with a large effect size (d = 1.69) and 65% of participants responding positively compared to only 7% in the treatment as usual (TAU) group.

The E/RP therapy was well-tolerated and maintained its benefits over a 3-month follow-up, demonstrating that even children as young as 3 years can successfully engage in this developmentally tailored treatment with high family involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family-based exposure and response prevention therapy for preschool-aged children with obsessive-compulsive disorder: a pilot randomized controlled trial. Lewin, AB., Park, JM., Jones, AM., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Preschool and Early Elementary School-Aged Children in Exposure and Response Prevention (ERP). Metcalfe, RE., Pental, P., Duke, DC.[2022]

In a small study involving three adolescents with persistent obsessive-compulsive disorder (OCD), an eight-day intensive exposure and response prevention (ERP) therapy showed promising results, with two patients experiencing symptom improvement and one achieving full remission.

This suggests that intensive, therapist-assisted ERP, especially when involving family members, could be an effective next step for adolescents who do not respond adequately to standard cognitive behavioral therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Intensive, short-term treatment for adolescents with persevering obsessive-compulsive disorder: three case-reports]. Eenink, SM., Kampman, M., Hendriks, L., et al.[2020]

A study involving 30 adults with OCD found that a stepped care approach to exposure and response prevention (ERP) was equally effective as standard ERP, with 67% of stepped care participants achieving significant improvement compared to 50% in the standard group.

The stepped care model significantly reduced treatment costs for patients and payers without compromising treatment efficacy or patient satisfaction, suggesting it could be a more accessible option for OCD treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stepped care versus standard cognitive-behavioral therapy for obsessive-compulsive disorder: a preliminary study of efficacy and costs. Tolin, DF., Diefenbach, GJ., Gilliam, CM.[2021]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician-reported barriers to using exposure with response prevention in the treatment of paediatric obsessive-compulsive disorder. Keleher, J., Jassi, A., Krebs, G.[2021]

In a study involving 35 youth with obsessive-compulsive disorder (OCD), greater variability in distress during exposure therapy and completing more combined exposures were linked to better treatment outcomes, suggesting that how youth experience and engage with therapy can significantly impact their recovery.

Conversely, higher distress levels at the end of treatment were associated with poorer outcomes, indicating that managing distress during therapy is crucial for effective treatment of OCD in children and adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure and response prevention process predicts treatment outcome in youth with OCD. Kircanski, K., Peris, TS.[2022]

A case study of a 7-year-old boy with obsessive-compulsive disorder (OCD) demonstrated significant improvement in symptoms and functioning through family-based cognitive-behavioral therapy (CBT) using exposure with response prevention (ERP).

The treatment emphasized family involvement, understanding the relationship between obsessions and compulsions, and creating conditions for habituation, highlighting the effectiveness of these strategies in adapting ERP for young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Family-Based Exposure With Response Prevention to Treat Obsessive-Compulsive Disorder in Young Children: A Case Study. Herren, J., Freeman, J., Garcia, A.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3207204/

PMC - PubMed Central We found that group-based ERP was effective in reducing pediatric OCD symptom severity in a naturalistic treatment setting irrespective of age or gender.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6343408/

Exposure and response prevention for obsessive-compulsive ... Despite the success of ERP in treating OCD, there is room for improvement. As noted above, many people drop out of treatment prematurely and a substantial ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S016517812200453X

The effect of exposure and response prevention therapy on ... In addition, compared with the control group, ERP reduced depression (g = 0.15) and anxiety symptoms (g = 0.23) in patients with OCD. Meta-regression results ...

4. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.973838/full

The effectiveness of exposure and response prevention ... Conclusion: Patients with OCD have significant improvement in symptoms of obsessive-compulsive disorder and depression when ERP is combined with medication, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2211364918300769

Concentrated exposure and response prevention for ... Cognitive behavioral therapy (CBT) with exposure and response prevention (ERP) is recommended as first line treatment for pediatric OCD (Geller & March, 2012).

6. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2834260

Exposure Therapy in Mixed Reality for Obsessive ... This randomized clinical trial compares the efficacy of exposure and response prevention therapy in mixed reality with self-guided exposure ...

7. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-022-03701-z

effects of habituation and expectancy violation on short-term ... Exposure and response prevention is effective and recommended as the first choice for treating obsessive-compulsive disorders (OCD).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4305046/

Exposure and Response Prevention Process Predicts ... Hedtke et al. (2009) found in their sample with non-OCD anxiety disorders that completing fewer exposure tasks predicted improved outcomes, whereas Benito et al ...