Stepped Care Treatment for Anxiety Resilience

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-17
SponsorAndrew Wiese

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

-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.

Trial design

Treatments tested in this trial

  • Relaxation and Mentorship Training (RMT)
  • Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)

Treatment groups

106 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Andrew Wiese

Lead sponsor

Baylor College of Medicine

Sponsor institution

Baylor College of Medicine

Collaborator