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Stepped Care Treatment for Anxiety Resilience
NCT07228143 · Baylor College of Medicine
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Stepped Care Cognitive Behavioral Therapy for Children and Adolescents With Anxiety
About this study
Anxiety disorders in children and adolescents (CAD) are common and confer significant impairment in academic, peer, and family functioning. If left inadequately treated, CAD remains chronic and increases the risk of physical and mental health problems, unemployment, substance use disorders, and suicidality in adulthood. Family-based cognitive behavioral therapy (CBT) has demonstrated efficacy in the treatment of CAD. Yet, many children do not receive care due to barriers such as limited provider availability, high treatment cost, and familial constraints (e.g., time). Effective, personalized treatment approaches that are accessible, efficient, and cost-effective are needed. To combat these barriers, other treatment methods have been developed.
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. Stepped care is an alternative low-intensity parent focused delivery system that incorporates the best available evidence to treat CAD within a stepped care model, which utilizes task-shifting with parent involvement, honoring the role of parents in helping their children.
\*The hypothesized treatment mechanisms include parent-focused targets (i.e., family accommodation, parental distress) and child-focused targets (i.e., emotional processing, inhibitory learning) and child-focused targets (i.e., emotional processing, inhibitory learning). The stepped care model would task-shift therapeutic components to parents using scalable multi-media-based content.
Although stepped care approaches show promise in treating CAD with comparable efficacy to standard CBT, there remains a large research-to-practice gap and very little is known about intervention mediators that explain mechanisms of change.
This research is being done to understand and 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.
Study design
Enrollment target: 106 participants
Allocation: randomized
Masking: none
Age groups: child
Timeline
Starts: 2026-01-05
Estimated completion: 2028-04-30
Last updated: 2026-03-02
Interventions
Behavioral: Relaxation and Mentorship Training (RMT)Behavioral: Stepped Care Targeting Exposure and Parenting for Anxiety (STEP-A)
Primary outcomes
- • Pediatric Anxiety Rating Scale (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 (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 (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))
Sponsor
Andrew Wiese · other
With: Baylor College of Medicine
Contacts & investigators
ContactAndrew D Wiese, PhD · contact · andrew.wiese@bcm.edu · 713-798-3080
ContactJazzmine Ward, BS · contact · jazzmine.ward@bcm.edu
All locations (1)
Baylor College of MedicineRecruiting
Houston, Texas, United States