Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05967468
• Other study ID #: H-53969
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2023
• Est. completion date: March 2025

Study information

• Verified date: February 2024
• Source: Baylor College of Medicine
• Contact: Daphne Ayton, B.A.
• Phone: 832-206-4034
• Email: daphne.ayton[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Agoraphobia
• Anxiety Disorder of Childhood
• Anxiety Disorders
• Anxiety, Separation
• Generalized Anxiety Disorder
• Obsessive-Compulsive Disorder
• Obsessive-Compulsive Disorder in Adolescence
• Obsessive-Compulsive Disorder in Children
• Panic Attacks
• Panic Disorder
• Panic Disorder With Agoraphobia
• Phobia, Social
• Separation Anxiety
• Social Anxiety Disorder of Childhood

Intervention

Behavioral:
• Family Based, Internet-Based Cognitive Behavioral Therapy
Family-based cognitive behavioral therapy employing internet-delivered modules and videos
• Bibliotherapy, low therapist contact SPACE
Parent-based bibliotherapy for treating anxiety disorders in youth

Other:
• Relaxation and Mentorship
Relaxation based treatment

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in clinician-rated child anxiety severity throughout the past week.	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	Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings	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
Secondary	Clinical Global Impression-Severity	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