Stepped Care Treatment for Anxiety

(STAR Trial)

Overseen By Jazzmine Ward, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Andrew Wiese

Must not be taking: Antidepressants, Antipsychotics, Benzodiazepines, ADHD medications

Disqualifiers: Psychosis, Cognitive disability, Suicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks better treatments for anxiety disorders in children through a stepped care approach. It begins by teaching parents to help their children manage anxiety via a structured program and, if necessary, progresses to more intensive therapy sessions. This method, known as Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A), aims to make treatment more accessible and affordable for families. Children aged 7-17 living in Texas with a diagnosis of an anxiety disorder, such as separation anxiety or social phobia, may be suitable for this trial. As an unphased trial, it offers families the chance to access innovative treatment strategies that could significantly enhance their children's well-being.

Will I have to stop taking my current medications?

You don't have to stop your current medications, but they need to be stable. If you've started a new antidepressant in the last 12 weeks or changed any psychotropic medication in the last 6 weeks, you might not be eligible. Your medications should stay the same during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) model builds on well-studied treatments like cognitive behavioral therapy (CBT). This method effectively treats anxiety in children. Studies indicate that stepped care models, which begin with simpler treatments, are generally well-received by patients. This approach aims to be affordable while still providing good care.

The STEP-A treatment involves parents and uses proven techniques like exposure therapy, which gradually faces fears, to help children manage anxiety. Research on similar parent-focused treatments suggests they are safe and usually do not cause serious side effects. Involving families more in the treatment can improve results without adding risk.

The Relaxation and Mentorship Training (RMT), used for comparison, has served as a control condition in various anxiety studies. It includes relaxation techniques and supportive practices and is designed to be safe and low-risk.

In summary, both treatments in this trial are based on established, safe methods for treating anxiety in children. They are designed to be low-risk and provide effective support without significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) because it offers a unique, structured approach for treating child and adolescent anxiety by directly involving parents and focusing on exposure techniques. Unlike traditional therapies that may not actively include parental involvement, STEP-A emphasizes parents' roles in the therapeutic process, enhancing the generalization of skills learned in therapy to real-life situations. Additionally, the treatment is delivered in a flexible two-step process, allowing for an initial evaluation and a subsequent, more intensive intervention if needed, which could lead to more efficient and effective outcomes compared to standard CBT options.

What evidence suggests that this trial's treatments could be effective for childhood anxiety disorders?

This trial will compare two approaches for treating anxiety in children: Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) and Relaxation and Mentorship Training (RMT). Research has shown that a stepped care approach, like STEP-A, can be as effective as traditional cognitive behavioral therapy (CBT). Early studies suggested that starting with a treatment focused on parents can be both efficient and cost-effective. Evidence indicates that when parents lead therapy, their children's anxiety symptoms can improve significantly. Stepped care methods begin with simple, low-intensity treatments and can adjust to more intensive ones if needed, offering flexibility and practicality for families. This approach aims to address challenges like high costs and limited availability of therapists, providing a promising option for treating anxiety in children. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for children with various anxiety disorders, including social anxiety, separation anxiety, phobias, OCD, and panic disorder. It aims to help those who face barriers to traditional therapy due to provider availability or cost.

Inclusion Criteria

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

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

I have been diagnosed with OCD or an anxiety disorder.

Exclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Step 1 Treatment

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.

8 weeks

4 visits (in-person)

Step 2 Treatment

PCET, a family-based CBT protocol, with ten weekly sessions focusing on psychoeducation, exposure hierarchy development, and in-session exposure practice.

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests a 'stepped care' approach starting with low-intensity Relaxation and Mentorship Training (RMT) followed by more intensive Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) if needed.

How Is the Trial Designed?

Group I: Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A) Experimental Treatment 1 Intervention

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.

Group II: Relaxation and Mentorship Training Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Andrew Wiese

Lead Sponsor

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07228143?lastUpdPost=2020-01-16_

Stepped Care Treatment for Anxiety Resilience A stepped care model for CAD that begins with a parent-focus intervention has great promise to deliver efficacious and cost-effective treatment ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7678910/

Parent-led, stepped-care cognitive-behavioral therapy for ... This paper describes the design, rationale, and methodology of a study examining stepped-care CBT for youth with HFA and co-occurring anxiety.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0165032722004207

The impact of parent-only interventions on child anxiety Child anxiety symptoms reduced in all conditions when compared to other treatments. •. Low intensity interventions may have positive outcomes ...

4. clinicaltrial.be clinicaltrial.be/en/details/188671?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Initial Evaluation of a Stepped Care Model for Treating M... Numerous studies have found evidence for the efficacy of CBT in the treatment of child anxiety, but typically, these treatment programs have ...

5. link.springer.com link.springer.com/article/10.1007/s10578-025-01908-1

Stepped Care Versus Stratified Care for Youth with Anxiety ... Stepped care, where all patients initially receive low-intensity treatment, has gained traction due to its potential cost-effectiveness.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11256210/

Current and Future Approaches to Pediatric Anxiety Disorder ... This overview critically appraises literature on the treatment of pediatric anxiety disorders. The two established treatments for these conditions comprise ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03720795

Stepped-Care Cognitive-Behavioral Treatment for Youth ... This study implements a parent-led, flexible, individually-tailored cognitive-behavioral intervention for children with ASD and anxiety.