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Behavioural Intervention

Family-Based Behavioral Therapy for Childhood Anxiety and OCD

N/A

Recruiting

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up

Awards & highlights

Study Summary

This trial evaluates two lower-intensity treatments for anxiety & OCD in children, delivered either over the internet or with a therapist. The goal is to increase access to care.

Who is the study for?

This trial is for children aged 7-13 in Texas with significant anxiety or OCD, as indicated by specific test scores. They must have the ability to engage in CBT and live with a participating parent at least half the time. Children on stable medication may qualify, but those starting new treatments recently or changing dosages are excluded.Check my eligibility

What is being tested?

The study compares family-based and internet-delivered cognitive behavioral therapy (CBT) against Relaxation and Mentorship Training (RMT). It aims to determine which method is more effective for treating anxiety and OCD in youth through telehealth services.See study design

What are the potential side effects?

Since this trial involves non-pharmaceutical interventions like therapy and relaxation techniques, typical drug side effects aren't expected. However, participants might experience discomfort discussing personal issues or practicing new skills.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in clinician-rated child anxiety severity throughout the past week.

Secondary outcome measures

Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings

Clinical Global Impression-Severity

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Parent Training Bibliotherapy (SPACE)Experimental Treatment1 Intervention

One third of participants will be randomized to the SPACE group. Families will receive 4 45-minute supportive video calls with a therapist over the course of 12-14 weeks. Participating families will receive a copy of the book 'Breaking Free of Child Anxiety and OCD' to use at home and in session with the therapist. During each of the video-conferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.

Group II: Family-Based Internet-Based CBT Group (iCBT)Experimental Treatment1 Intervention

One third of participants will be randomized to receive iCBT. Each week of treatment, the parent will be encouraged to read the corresponding materials on the Baylor College of Medicine (BCM) webpage, complete accompanying worksheets, and guide their child through completing activities in the child-facing materials, with support from a therapist (6 30-minute supportive videoconferencing via Zoom, 6 emails on alternating weeks). One core aspect of treatment will be parents leading their child through graduated exposure. Exposures, a hallmark of CBT for anxiety, are used to gradually and repeatedly confront feared stimuli. For example, exposure therapy for a child fearful of dogs may begin with looking at pictures of dogs and standing across the park from a dog on a leash, to eventually petting a dog. All relevant information regarding parent-led exposures will be detailed in the treatment materials, and therapists will review with parents via email and/or video-conferencing sessions.

Group III: Active ComparatorActive Control1 Intervention

One third of participants will be randomized to receive a Relaxation and Mentorship. This involves attending 4 45-minute sessions with a therapist over the course of 12-14 weeks. Topics covered include breathing slowly and deeply, coloring activities, and releasing muscle tension to reduce stress levels.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bibliotherapy, low therapist contact SPACE

2021

Completed Phase 3

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor

1,001 Previous Clinical Trials

6,002,312 Total Patients Enrolled

14 Trials studying Obsessive-Compulsive Disorder

662 Patients Enrolled for Obsessive-Compulsive Disorder

Media Library

Family Based (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05967468 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor include elderly participants?

"The minimum age requirement for prospective participants is 7, while the upper limit of enrolment is 13. This abides by the inclusion criteria set forth in this clinical trial."

Answered by AI

Do I meet the prerequisites to join this research project?

"To be included in this research project, applicants must possess obsessive-compulsive disorder and should fall into the age range of 7 to 13 years old. The investigation currently seeks a cohort of 100 patients."

Answered by AI

Are there currently slots available to join this research endeavor?

"According to the information on clinicaltrials.gov, this medical project is no longer seeking participants at present time; it was initially posted in August 1st 2023 and last edited July 28th of the same year. Despite that, there are 517 other trials actively enrolling patients now."

Answered by AI