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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Clinical Global Impression-Severity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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