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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
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
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,028 Previous Clinical Trials
6,030,062 Total Patients Enrolled
1 Trials studying Panic Attacks
68 Patients Enrolled for Panic Attacks
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child currently has severe thoughts of harming themselves or others, needing medical help.My child is currently being treated for anxiety.My mental health medications have been stable for the last 4 weeks.My child is between 7 and 13 years old.My child can understand and communicate well enough for cognitive behavioral therapy.I started taking antidepressants or certain other medications recently.My child's anxiety or OCD is severe, scoring 12+ on the PARS.The child is suitable for treatment centered around battling anxiety, as determined by the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).