Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria
NCT ID: NCT06560736
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-10-01
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate Intervention Group
Show Me FIRST coping skills intervention
Show Me FIRST is a flexible, transdiagnostic intervention organized around well-tested principles of youth psychotherapeutic change.
Wait List / Delayed Intervention Group
Show Me FIRST coping skills intervention
Show Me FIRST is a flexible, transdiagnostic intervention organized around well-tested principles of youth psychotherapeutic change.
Interventions
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Show Me FIRST coping skills intervention
Show Me FIRST is a flexible, transdiagnostic intervention organized around well-tested principles of youth psychotherapeutic change.
Eligibility Criteria
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Inclusion Criteria
* Formal diagnosis of PKU (as confirmed/reported by caregiver): identified by newborn screening with PKU as evidenced by a blood Phe level ≥ 360μmol/L; received treatment within the first 30 days of life.
* Interest in receiving a brief, psychotherapeutic skills program to prevent and treat symptoms of anxiety and/or depression, according to parent- and youth-report
* Located in Missouri, Kansas, or Illinois.
Exclusion Criteria
* Plans to receive non-study psychotherapy during the course of study participation, according to parent- or youth-report
* Plans to change current psychoactive or PKU-related medication during the course of study participation, according to parent- or youth-report
* Have active suicidal ideation that would necessitate immediate treatment or require higher level of care than brief psychotherapy, according to parent- or youth-report
10 Years
17 Years
ALL
No
Sponsors
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National PKU Alliance
UNKNOWN
University of Missouri-Columbia
OTHER
Responsible Party
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Shawn Christ
Associate Professor of Psychological Sciences
Locations
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University of Missouri
Columbia, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Shawn Christ
Role: primary
Other Identifiers
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2103266
Identifier Type: -
Identifier Source: org_study_id