Actively Recruiting

Phase Not Applicable
Age: 7Years - 17Years
All Genders
ID07228143

Stepped Care Cognitive Behavioral Therapy for Children and Adolescents With Anxiety

Led by Andrew Wiese · Updated on 2026-03-02

106

Participants Needed

1

Research Sites

34 weeks

Total Duration

On this page

Sponsors

A

Andrew Wiese

Lead Sponsor

B

Baylor College of Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying childhood anxiety disorders (CAD), which are common and can affect school, friendships, and family life. This trial focuses on a stepped care model that starts with parent-focused treatment to help children with anxiety. The study aims to improve access to effective care by testing a low-intensity, affordable approach that involves parents, addressing barriers like limited providers and high costs. The study compares two treatments: Relaxation and Mentorship Training (RMT), which includes 14 sessions of relaxation techniques and writing activities, and Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A). STEP-A involves two steps: first, parents read a book and attend four therapy sessions while practicing tasks with their child, then responders receive 10 weeks of family-based cognitive behavioral therapy focused on exposures and increasing parental involvement. Participants aged 7 to 17 with diagnosed anxiety disorders will attend therapy sessions and be assessed at multiple time points using anxiety rating scales and clinical interviews. Researchers will track progress before, during, and after treatment, including follow-ups at one month and longer-term caregiver interviews. The study runs until 2028 and seeks to better understand how stepped care works and its benefits for children with anxiety.

CONDITIONS

Brief Title

Stepped Care Treatment for Anxiety Resilience

Who Can Participate

Age: 7Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • A primary diagnosis of OCD or an anxiety disorder including separation anxiety disorder, social phobia, generalized anxiety disorder, specific phobia, agoraphobia, or panic disorder determined by a diagnostic interview.
  • A score of 14 or higher on the Pediatric Anxiety Rating Scale indicating clinically significant anxiety.
  • Child is between 7 and 17 years old.
  • Residence in Texas and plan to stay in Texas during treatment sessions.
Not Eligible

You will not qualify if you...

  • Psychosis, cognitive disability, or any condition limiting caregiver's ability to follow instructions.
  • Parent substance use disorder within the past 3 months.
  • Child or parent is suicidal; delayed entry possible after stabilization for more than 6 months.
  • Recent changes or initiation of psychotropic medications within specified time frames before enrollment; medications must remain stable during treatment.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for diagnostic interview and baseline assessments

Treatment

Duration - Up to 20 weeks

Participants receive behavioral therapy through either Relaxation and Mentorship Training (RMT) or Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A). RMT involves 14 sessions of relaxation training over several weeks. STEP-A consists of two steps: Step 1 includes four 45-minute parent sessions across 8 weeks with therapeutic tasks, followed by a 10-week maintenance period; Step 2 includes 10 weekly family-based CBT sessions focusing on exposure and parental involvement.

Weekly or biweekly therapy sessions totaling up to 14 sessions depending on assigned treatment

Follow-up

Duration - Up to 12 weeks after treatment completion

Participants are followed up to assess treatment outcomes and maintenance of effects through caregiver interviews and clinical assessments.

1 to 2 follow-up visits including caregiver interview and clinical evaluations

Trial Site Locations

Total: 1 location

1

Baylor College of Medicine

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

A

Andrew D Wiese, PhD

J

Jazzmine Ward, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A Meta-analysis to Guide the Enhancement of CBT for Childhood Anxiety: Exposure Over Anxiety Management.

Stephen P H Whiteside, Leslie A Sim, Allison S Morrow...

https://pubmed.ncbi.nlm.nih.gov/31628568

Assessing reliable change, MCID, treatment response, and remission using the Pediatric Anxiety Rating Scale (PARS) in youth with anxiety disorders.

Matti Cervin, Philip C Kendall, John C Piacentini...

https://pubmed.ncbi.nlm.nih.gov/40946358

A RANDOMIZED CONTROLLED TRIAL IN COMMUNITY MENTAL HEALTH CENTERS OF COMPUTER-ASSISTED COGNITIVE BEHAVIORAL THERAPY VERSUS TREATMENT AS USUAL FOR CHILDREN WITH ANXIETY.

Eric A Storch, Alison Salloum, Morgan A King...

https://pubmed.ncbi.nlm.nih.gov/26366886