- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05967468
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
February 13, 2024 updated by: Eric A Storch, Baylor College of Medicine
Anxiety and obsessive-compulsive disorders are among the most common in children.
Although cognitive behavioral therapy (CBT) is an effective and evidence-based treatment for such disorders, access to CBT is often limited.
Family-based and internet-delivered therapy is one method to increase access to care.
The purpose of this project is to evaluate the comparative efficacy and treatment mechanisms of two lower-intensity but effective treatments for families of children with anxiety or obsessive compulsive disorder (OCD) via telehealth compared to an adapted Relaxation and Mentorship Training (RMT) intervention involving breathing exercises with a therapist.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Cognitive-behavioral therapy (CBT) is an effective treatment for anxiety, yet access to CBT is limited for most families due to the cost, practicalities of attending in-person treatment sessions, and limited availability of trained therapists.
Low-intensity telehealth delivery of services is a promising method to improve access to care for youth with anxiety and their families, givens its reachability to a wider range of areas (e.g., rural/underserved) and its ability to minimize practical barriers (e.g., treatment could be delivered to home without need for travel), and reduce stigma (e.g., parents do not need to visit mental health clinics).
Additionally, parent-involved treatments for youth anxiety are effective and have the potential to reach more children and adolescents who refuse to see a therapist.
However, these interventions have not been widely evaluated.
The goal of this project is to evaluate the comparative efficacy and treatment mechanisms of two lower-intensity but effective treatments for families of children with anxiety or obsessive compulsive disorder (OCD) via telehealth compared to an adapted Relaxation and Mentorship Training (RMT) intervention involving breathing exercises with a therapist.
This study involves two CBT-based intervention groups, both of which have demonstrated efficacy in prior work: 1) a parent-led, therapist-supported Internet based CBT intervention (iCBT) and 2) parent training paired with bibliotherapy intervention (SPACE).
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Daphne Ayton, B.A.
- Phone Number: 832-206-4034
- Email: daphne.ayton@bcm.edu
Study Contact Backup
- Name: Eric Storch, Ph.D.
- Phone Number: (713) 798-3579
- Email: eric.storch@bcm.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- Baylor College of Medicine
-
Contact:
- Eric Storch, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The child is between the ages of 7 to 13 years inclusion at enrollment
- The child has clinically significant symptoms of anxiety and/or OCD, as indicated by a score of 12 or higher on the Pediatric Anxiety Rating Scale (PARS).
- The child is appropriate for anxiety-focused treatment (e.g., anxiety is the primary or co-primary problem as diagnosed using the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- One parent/guardian is able and willing to participate in assessment and treatment (e.g., has sufficient English fluency, the decisional capacity to participate, and can commit to treatment duration).
- The participating parent/guardian lives with their child at least 50% of the time per self-report.
- Both parent and child are able to read and understand English.
- The child has the intellectual and communication skills to engage in CBT, as judged by an experienced supervising clinician.
- Participants must be in the state of Texas for treatment sessions/assessments.
Exclusion Criteria:
- the child has a diagnosis of child lifetime bipolar disorder, drug or alcohol dependence, psychotic disorder, or conduct disorder.
- the child has severe, current suicidal/homicidal ideation and/or self-injury requiring medical intervention (referrals will be made for appropriate clinical intervention).
- the child is receiving concurrent therapy for anxiety.
- New Treatments: Initiation of an antidepressant within 12 weeks before study enrollment OR 6 weeks for an antipsychotic, benzodiazepine, or attention deficit hyperactivity disorder (ADHD) medication before study enrollment. Established Treatment changes: Any change in established psychotropic medication (e.g., antidepressants, anxiolytics, antipsychotic) within 4 weeks before study enrollment. Any medications must remain stable during treatment; downward adjustments due to side effects may be acceptable.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Family-Based Internet-Based CBT Group (iCBT)
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.
|
Family-based cognitive behavioral therapy employing internet-delivered modules and videos
|
Experimental: Parent Training Bibliotherapy (SPACE)
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.
|
Parent-based bibliotherapy for treating anxiety disorders in youth
|
Active Comparator: Active Comparator
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.
|
Relaxation based treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in clinician-rated child anxiety severity throughout the past week.
Time Frame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
|
Each item is scored on a 0 to 5 scale (higher scores correspond to greater severity), yielding a total between 0 and 30.
|
baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings
Time Frame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
|
Clinician-rated diagnostic interview that includes current anxiety disorders, depression, obsessive-compulsive disorder, and related disorders.
Each diagnostic category is coded as present or absent based on symptom criteria and clinical severity ratings (CSRs), which indicate the level of clinical interference.
CSRs are scored on a 0-8 scale (0 = not at all; 8 = very, very much).
CSRs of 4 or above indicate the clinical levels.
|
baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
|
Clinical Global Impression-Severity
Time Frame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
|
Clinician-rated child psychopathology severity rating.
A single item is scored 0-6 (0= no illness; 6= extremely severe symptoms).
|
baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2023
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
July 12, 2023
First Submitted That Met QC Criteria
July 28, 2023
First Posted (Actual)
August 1, 2023
Study Record Updates
Last Update Posted (Actual)
February 14, 2024
Last Update Submitted That Met QC Criteria
February 13, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-53969
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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