Actively Recruiting
Development of Novel Psychological Assessment Tools and Anxiety Intervention for PKU: Intervention Trial
Led by University of Missouri-Columbia · Updated on 2025-12-23
30
Participants Needed
1
Research Sites
N/A
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
This research aims to evaluate a short-term skills-based intervention called Show Me FIRST for treating anxiety and depression in adolescents aged 10 to 17 with Phenylketonuria (PKU). The study also seeks to validate new psychological assessment tools that use ecological momentary assessment to capture real-time neurocognitive and psychological functions. Thirty adolescents with PKU and a history of anxiety or depression will take part in this randomized controlled trial. Participants will be randomly assigned to either an immediate intervention group or a wait-list/delayed intervention group, with each group receiving the 10-week Show Me FIRST program. The intervention and assessments are delivered remotely via secure videoconferencing and cell-phone applications, making participation accessible and convenient. During the study, participants will complete comprehensive psychological and cognitive evaluations at three timepoints: weeks 0, 11, and 22. These evaluations include various standardized scales and tests to measure anxiety, depression, executive function, attention, sleep, and blood phenylalanine levels. Researchers will closely monitor these outcomes to assess the intervention's impact and the validity of the assessment tools over the course of the study.
CONDITIONS
Brief 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 a parent or guardian
- Formal diagnosis of PKU confirmed by newborn screening with blood phenylalanine level 60 bcmol/L
- Received PKU treatment within the first 30 days of life
- Interested in a brief psychotherapeutic program for anxiety and/or depression symptoms
- Located in Missouri, Kansas, or Illinois
You will not qualify if you...
- Significant intellectual disability (IQ less than 70) or language difficulties interfering with psychotherapy
- 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 care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (remote)
Duration - 10 weeks
Participants receive the 10-week Show Me FIRST coping skills intervention for anxiety and depression delivered remotely via secure videoconference and phone applications.
Weekly remote sessions
Duration - Up to 22 weeks
Participants complete psychological and neurocognitive evaluations at Weeks 0, 11, and 22 to assess treatment outcomes remotely.
3 remote assessment visits
Trial Site Locations
Total: 1 location
1
University of Missouri
Columbia, Missouri, United States, 65201
Actively Recruiting
Research Team
S
Shawn Christ
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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