Status:
ACTIVE_NOT_RECRUITING
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Lead Sponsor:
Baylor College of Medicine
Conditions:
Obsessive-Compulsive Disorder in Children
Anxiety Disorder of Childhood
Eligibility:
All Genders
7-13 years
Phase:
NA
Brief Summary
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05967468
Start Date
September 14 2023
End Date
June 30 2026
Last Update
July 24 2025
Active Locations (1)
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1
Baylor College of Medicine
Houston, Texas, United States, 77030