Clinical trial NCT05967468: Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Official title: Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obsessive-Compulsive Disorder in Children
Anxiety Disorder of Childhood
Social Anxiety Disorder of Childhood
Obsessive-Compulsive Disorder in Adolescence
Generalized Anxiety Disorder
Separation Anxiety
Panic Disorder
Panic Disorder With Agoraphobia
Panic Attacks
Keywords: obsessive-compulsive disorder
anxiety
cognitive-behavioral therapy
children
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children (N=100), ages 7-13 will be randomized to one of three conditions
Primary purpose: TREATMENT

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 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in clinician-rated child anxiety severity throughout the past week.
timeFrame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
Secondary outcomes:
measure: Anxiety Disorders Interview Schedule (ADIS-IV) with Clinical Severity Ratings
timeFrame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
measure: Clinical Global Impression-Severity
timeFrame: baseline (before treatment), during treatment (on average 14 weeks), post-treatment (last week of treatment), 1 month follow up
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
References: