Stepped care program for anxiety in children and teens

Stepped Care Cognitive Behavioral Therapy for Children and Adolescents With Anxiety

This program will see if a stepped care approach that starts with parent-focused support and steps up to child therapy can help children and teens (ages 7–17) in Texas with anxiety disorders or OCD.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 7 Years to 17 Years
• Sex: All
• Sponsor: Baylor College of Medicine (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT07228143 on ClinicalTrials.gov

What this trial studies

This interventional program uses a stepped care model that begins with a low-intensity, parent-focused intervention (Relaxation and Mentorship Training) and moves to a more intensive child- and parent-focused intervention (STEP-A) for those who need additional care. Eligible participants are children aged 7–17 with a primary anxiety disorder or OCD confirmed by the DIAMOND-KID interview and clinically significant symptoms (PARS score ≥14). The approach emphasizes task-shifting to parents, targets parent behaviors (e.g., family accommodation, parental distress) and child processes (e.g., emotional processing, inhibitory learning), and measures symptom change and need for stepping up. Treatment is delivered at Baylor College of Medicine with predefined criteria guiding escalation from the low-intensity to the higher-intensity intervention.

Who should consider this trial

Good fit: Ideal candidates are children aged 7–17 living in Texas with a primary diagnosis of an anxiety disorder or OCD, clinically significant symptoms (PARS ≥14), and a caregiver able to participate in the parent-focused intervention.

Not a fit: Children or families with psychosis, cognitive disability, active suicidality, a caregiver with recent substance use disorder, ongoing destabilizing medication changes, or those living outside Texas are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could expand access to effective, lower-cost care by helping many children improve using parent-focused steps and reserving intensive therapy for those who need it.

How similar studies have performed: Prior stepped care and parent-focused CBT programs have shown promising results comparable to standard CBT, but beginning with a parent-only stepped approach remains relatively novel and under active study.

Eligibility criteria

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.

Where this trial is running

Houston, Texas

• Baylor College of Medicine — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Andrew D Wiese, PhD

Conditions Generalized Anxiety Disorder; Social Anxiety Disorder; Separation Anxiety Disorder; Specific Phobia; Obsessive Compulsive Disorder; Panic Disorder; Anxiety; Child