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RECRUITING
NCT06560736
NA

Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

Sponsor: University of Missouri-Columbia

View on ClinicalTrials.gov

Summary

While previous PKU intervention research has largely focused on pharmacological treatment of elevated Phe levels, the adaptation of evidence-based psychosocial therapy holds promise for addressing cognitive and psychological symptoms and significantly improving quality of life. Study goals include: (1) to demonstrate the efficacy and feasibility of a short-term skills-based intervention (Show Me FIRST) for anxiety and depression in adolescents with PKU, and (2) to further establish the psychometric validity of novel assessment measures recently developed by the Investigators that utilize ecological momentary assessment (EMA) to capture "in the moment" neurocognitive and psychological function. The Investigators propose to conduct a randomized controlled trial wherein 30 adolescents with PKU will be randomized to either an immediate intervention group or wait-list/delayed intervention group.

Official title: Development of Novel Psychological Assessment Tools and Anxiety Intervention for PKU: Intervention Trial

Key Details

Gender

All

Age Range

10 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-10-01

Completion Date

2026-08-31

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

BEHAVIORAL

Show Me FIRST coping skills intervention

Show Me FIRST is a flexible, transdiagnostic intervention organized around well-tested principles of youth psychotherapeutic change.

Locations (1)

University of Missouri

Columbia, Missouri, United States