NCT07228143 Stepped Care Treatment for Anxiety Resilience
| NCT ID | NCT07228143 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Andrew Wiese |
| Condition | Generalized Anxiety Disorder (GAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2026-01-05 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 106 participants in total. It began in 2026-01-05 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07228143 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, up to 17 Years, studying Generalized Anxiety Disorder (GAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07228143 currently recruiting?
Yes, NCT07228143 is actively recruiting participants. Contact the research team at andrew.wiese@bcm.edu for enrollment information.
Where is the NCT07228143 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07228143 clinical trial?
NCT07228143 is sponsored by Andrew Wiese. The trial plans to enroll 106 participants.
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