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

Last updated: June 20, 2024
Sponsor: Baylor College of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obsessive-compulsive Disorder

Anxiety Disorders

Panic Disorders

Treatment

Family Based, Internet-Based Cognitive Behavioral Therapy

Bibliotherapy, low therapist contact SPACE

Relaxation and Mentorship

Clinical Study ID

NCT05967468
H-53969
  • Ages 7-13
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 bya 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 primaryor co-primary problem as diagnosed using the Mini-International NeuropsychiatricInterview 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, andcan commit to treatment duration).

  • The participating parent/guardian lives with their child at least 50% of the timeper 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 judgedby an experienced supervising clinician.

  • Participants must be in the state of Texas for treatment sessions/assessments.

Exclusion

Exclusion Criteria:

  • the child has a diagnosis of child lifetime bipolar disorder, drug or alcoholdependence, psychotic disorder, or conduct disorder.

  • the child has severe, current suicidal/homicidal ideation and/or self-injuryrequiring medical intervention (referrals will be made for appropriate clinicalintervention).

  • the child is receiving concurrent therapy for anxiety.

  • New Treatments: Initiation of an antidepressant within 12 weeks before studyenrollment OR 6 weeks for an antipsychotic, benzodiazepine, or attention deficithyperactivity disorder (ADHD) medication before study enrollment. EstablishedTreatment 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 toside effects may be acceptable.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Family Based, Internet-Based Cognitive Behavioral Therapy
Phase:
Study Start date:
September 14, 2023
Estimated Completion Date:
September 30, 2025

Study 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).

Connect with a study center

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Active - Recruiting

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