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NCT06560736 · ClinicalTrials.gov registry record · NA
Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria
A NA study of Phenylketonurias, sponsored by University of Missouri-Columbia.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06560736: Recruiting NA study of Phenylketonurias, sponsored by University of Missouri-Columbia.
NCT06560736 is a NA study of Phenylketonurias that is actively recruiting participants, run by University of Missouri-Columbia. The registered enrollment target is 30 participants, below the 40-participant average among 5 other Phenylketonurias trials with a reported enrollment target (25% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06560736, a NA study of Phenylketonurias, is actively recruiting participants, sponsored by University of Missouri-Columbia.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Patient-reported outcome (PRO) measure of anxiety \& depression symptoms
Conditions Studied
Interventions
- BEHAVIORAL Show Me FIRST coping skills intervention
Study Locations (1)
Missouri
- University of Missouri - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-10-01 |
| Est. Completion | 2026-08-31 |
| Phase | NA |
What NCT06560736 shows while recruiting
NCT06560736 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 40-participant average among 5 other Phenylketonurias trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Phenylketonurias appearing as the primary indexed condition, and to 1 intervention - of which Show Me FIRST coping skills intervention is the first listed.
NCT06560736 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT06560736 about?
NCT06560736 is a clinical study titled "Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria". 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: ...
What is the current status of trial NCT06560736?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-10-01. Estimated completion is 2026-08-31.
What conditions does trial NCT06560736 study?
This clinical trial studies the following conditions: Phenylketonurias.
What interventions are being tested in trial NCT06560736?
The interventions under investigation include: Show Me FIRST coping skills intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT06560736?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06560736 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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