Recruiting

Stepped Care ModelStepped Care Treatment for Anxiety Resilience

Sponsor:

Andrew Wiese

Code:

NCT07228143

Conditions

Generalized Anxiety Disorder (GAD)

Social Anxiety Disorder (SAD)

Separation Anxiety Disorder

Specific Phobia

Obsessive Compulsive Disorder (OCD)

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

Relaxation and Mentorship Training (RMT)

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

Study Details

Brief 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.

Conditions

Generalized Anxiety Disorder (GAD)

Social Anxiety Disorder (SAD)

Separation Anxiety Disorder

Specific Phobia

Obsessive Compulsive Disorder (OCD)

Study ID

NCT07228143

Start date

Jan 5, 2026

Status verified date

Feb, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 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.
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.

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Relaxation and Mentorship Training

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.

experimental: Stepped 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.

Interventions

Relaxation 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

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

Primary outcome measure

Pediatric Anxiety Rating Scale [ Time Frame: Baseline (before treatment or week 1), midway point (week 8), stepped care treatment (7 weeks), PCET during treatment (10 weeks), post (week 20), 1 month follow-up (week 24), caregiver interview (week 32) ]
The Clinical Global Impression-Severity [ Time Frame: Baseline (before treatment or week 1), midway point (week 8), stepped care treatment (7 weeks), PCET during treatment (10 weeks), post (week 20), 1 month follow-up (week 24), caregiver interview (week 32) ]
The Clinical Global Impression-Improvement [ Time Frame: Baseline (before treatment or week 1), midway point (week 8), stepped care treatment (7 weeks), PCET during treatment (10 weeks), post (week 20), 1 month follow-up (week 24), caregiver interview (week 32) ]

Central Contacts and Locations

Central contacts

Andrew D Wiese, PhD

713-798-3080 andrew.wiese@bcm.edu

Jazzmine Ward, BS

jazzmine.ward@bcm.edu

Locations

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Jazzmine Ward, BA

713-798-3579 starstudy@bcm.edu

Principal Investigator:

Andrew D Wiese, PhD

More Information

Sponsor

Andrew Wiese

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Keywords

Anxiety
Child
Adolescents
Obsessive compulsive disorder
stepped care
psychotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andrew Wiese on 2026-03-02.