Actively Recruiting
Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria
Led by University of Missouri-Columbia · Updated on 2025-12-23
30
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
U
University of Missouri-Columbia
Lead Sponsor
N
National PKU Alliance
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Youth aged 10 to 17 years with at least one parent or guardian
- Formal diagnosis of PKU confirmed by newborn screening with blood Phe level 2360bc mol/L
- Received treatment for PKU within the first 30 days of life
- Interest in receiving a brief skills program to prevent or treat anxiety and/or depression symptoms
- Resides in Missouri, Kansas, or Illinois
You will not qualify if you...
- Significant intellectual disability (IQ less than 70) or expressive/receptive language issues that interfere with therapy
- Plans to receive psychotherapy outside the study during participation
- Plans to change current psychoactive or PKU-related medication during participation
- Active suicidal thoughts requiring immediate or higher-level treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Missouri
Columbia, Missouri, United States, 65201
Actively Recruiting
Research Team
S
Shawn Christ
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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