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Stepped Care Treatment for Anxiety Resilience

Key facts

Who runs it
Andrew Wiese
Where
Houston, United StatesSee the site
Trial code
Status
Recruiting
People taking part
106 people, planned
Started
5 Jan 2026
Expected to end
30 Apr 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Relaxation and Mentorship Training (RMT)
  • Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)
Record updated
2 March 2026

Who can take part

Age
7 years to 17 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • -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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 7 and 17 years old?

Where in United States

  • Baylor College of MedicineHouston, United StatesContact: Jazzmine Ward, BATaking people

About the trial

What the trial wants to find out

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.

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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.

The 2 groups in the trial

  • Relaxation and Mentorship TrainingExisting treatment, for comparison

    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.

    Treatment: Relaxation and Mentorship Training (RMT)

  • Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)Treatment being tested

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Stepped Care Cognitive Behavioral Therapy for Children and Adolescents With Anxiety
Fit questions
Built from NCT07228143, who can take part
Record updated
2 March 2026