Obsessive-Compulsive Disorder (OCD) Clinical Trials

Find Obsessive-Compulsive Disorder (OCD) Clinical Trials Near You

Stepped Care Cognitive Behavioral Therapy for Children and Adolescents With Anxiety

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Childhood anxiety disorders (CAD) are common and impairing. Family based cognitive behavioral therapy (CBT) is efficacious in treating CAD. Yet, many children do not receive care due to barriers such as limited provider availably, high treatment costs, and constrained family resources (e.g., time). To combat these barriers, other treatment methods have been developed. The stepped care treatment models maximize resources by providing low-intensity, low-cost interventions as a first time treatment, while stepping up care for those needing more intensive treatment. Specifically, a stepped care model for CAD that begins with a parent-focus intervention has great promise to deliver efficacious and cost-effective treatment without having to engage the child. While stepped care approaches show promise in treating CAD with comparable efficacy to standard CBT, there remains a large research-to-practice gap. The stepped care model for CAD that begins with a parent-focused intervention has yet been explored, and very little is known about intervention mediators that explain mechanisms of change. This research is being done to improve the reach and quality of services using a stepped care model, offering an affordable and practical solution to the widespread gap in youth mental health care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 17
Healthy Volunteers: f
View:

• A primary diagnosis of OCD or an anxiety disorder including separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, agoraphobia, panic disorder, as determine by an IE using the DIAMOND-KID diagnostic interview.

• Score of ≥ 14 on the PARS (items 2-7) which corresponds to clinically significant anxiety.

• The child is 7-17 years old.

• Residence in Texas and located in the state of Texas during treatment sessions.

Locations
United States
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Andrew D Wiese, PhD
andrew.wiese@bcm.edu
713-798-3080
Backup
Jazzmine Ward, BS
jazzmine.ward@bcm.edu
Time Frame
Start Date: 2026-01-05
Estimated Completion Date: 2028-04-30
Participants
Target number of participants: 106
Treatments
Active_comparator: Relaxation and Mentorship Training
Families randomized to Relaxation and Mentorship Training (RMT) will receive 14 sessions of relaxation training to match intervention dosage in STEP-A. RMT is a multi-component relation-based protocol for children and adolescents experiencing anxiety. Initially designed as a control condition in multiple RCTs for CAD, the protocol integrates evidence-based relaxation strategies with non-anxiety specific elements, such as autobiographical writing. Sessions 1-7 will occur weekly across seven weeks to align timing of sessions 1-4 in Step 1 of STEP-A. Aligning the timing of Sessions 1-4 allows us to test treatment mechanisms, ensures equipoise between arms for cost-effeteness analyses keeping treatment durations equivalent. To ensure children in both conditions receive a full 14-sessions of therapy the last 4 sessions of RMT are staggered to mimic the staggering of SPACE in step one.
Experimental: Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)
STEP-A is a two-step treatment with Step 1 an abbreviated version of SPACE, which has demonstrated comparable efficacy to standard SPACE for CAD and OCD. In Step 1, parents read Breaking Free of Child Anxiety and OCD and engage in therapeutic tasks with their child while meeting with the therapist for four, 45-minute sessions at weeks 2, 4, 6, and 8. STEP-A Step 1 responders proceed to a 10-week maintenance period to practice skills learned.~Step 2 consists of PCET, an empirically validated family-based CBT protocol designed to treat CAD more effectively and efficiently than traditional CBT by emphasizing exposures and increasing parental involvement to maximize generalization. Ten weekly sessions with the therapist. Sessions 1 and 2 include psychoeducation and development of exposure hierarchy, while sessions 3, onward, emphasize in-session exposure practice and identifying between-session exposure homework, with parents leading in-session exposures starting session 5, onward.
Related Therapeutic Areas
Sponsors
Leads: Andrew Wiese
Collaborators: Baylor College of Medicine

This content was sourced from clinicaltrials.gov