RecruitingNot ApplicableNCT07228143

Stepped Care Treatment for Anxiety Resilience

Stepped Care Cognitive Behavioral Therapy for Children and Adolescents With Anxiety

Sponsor

Andrew Wiese

Enrollment

106 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Obsessive Compulsive Disorder (OCD)Specific Phobia Generalized Anxiety Disorder (GAD)Social Anxiety Disorder (SAD)Separation Anxiety Disorder Panic Disorder (With or Without Agoraphobia)

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

Min Age: 7 YearsMax Age: 17 Years

Inclusion Criteria4

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.

Exclusion Criteria4

Psychosis, cognitive disability, any condition that would limit the caregiver's ability to follow instructions.
Parent substance use disorder within the past 3 months, which could impact their ability to implement step 1
Child or parent is suicidal. A delayed entry once the parent or child is stabilized (\>6 months post suicidality) and no longer has suicidal ideation will be allowed if appropriate.
New pharmacological interventions or treatment changes: 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 enrollment, or any change in established psychotropic medication (e.g., antidepressants, anxiolytics) within 6 weeks before study enrollment (4 weeks for antipsychotic, anti-anxiety, benzodiazepine, or ADHD medication changes). Medications will remain stable during treatment.

Interventions

BEHAVIORALRelaxation and Mentorship Training (RMT)

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

BEHAVIORALStepped 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.