N/A
N=214
Brain Response Associated With Parent-based Treatment for Childhood Anxiety Disorders
Anxiety Disorder of Childhood · Separation Anxiety Disorder of Childhood · Social Anxiety Disorder of Childhood · Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03585010 ↗Enrolled (actual)
214
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Change From Baseline Anxiety Severity on the Pediatric Anxiety Rating Scale (PARS) at Week 12. — -11.82; -6.29; -8.47; -6.54 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supportive Parenting for Anxious Childhood Emotions (Behavioral); Parent Educational Support (Behavioral); Cognitive-Behavioral Therapy (Behavioral)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Anxiety Severity on the Pediatric Anxiety Rating Scale (PARS) at Week 12. |
-11.82; -6.29; -8.47; -6.54 | — |
| SECONDARY Change From Baseline Anxiety Severity on the Multimodal Anxiety Scale for Children (MASC) at Week 12. |
-21.79; -24.61; -22.55; -26.09; -17.17; -9.52 | — |
Summary
This study aims to investigate whether a parent-based treatment for childhood anxiety disorders engages child brain circuitry implicated in children's reliance on parents to reduce anxiety (R61), and whether change in child brain circuitry is associated with reduction in child anxiety (R33).
Eligibility Criteria
Inclusion Criteria
- Prepubertal
- Clinical diagnosis of primary anxiety disorder
- Must not have another mental illness more impairing than the most impairing anxiety disorder
- IQ of at least 80.
Exclusion Criteria
- Neurological disorders (including seizures)
- Organic mental disorders, psychotic disorders, or pervasive developmental disorders
- High likelihood of hurting themselves or others
- Current psychosocial or psychopharmacological treatment
- History of neurological illness or head injury with loss of consciousness > 5 minutes
- Vision or physical disability that interferes with seeing stimuli presented briefly on computer screen and/or clicking a mouse button rapidly and repeatedly
- Contraindications for MRI scanning (e.g., metal implants, pacemakers, braces, claustrophobia, pregnancy, weight > 250 pounds).
Data sourced from ClinicalTrials.gov (NCT03585010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.