Status:
RECRUITING
Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria
Lead Sponsor:
University of Missouri-Columbia
Collaborating Sponsors:
National PKU Alliance
Conditions:
Phenylketonurias
Eligibility:
All Genders
10-17 years
Phase:
NA
Brief 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 cog...
Detailed Description
A sample of 30 adolescents (age 10-17) with PKU and a history of elevated anxiety and/or depression symptomatology will be recruited to participate in a randomized control trial. Following screening a...
Eligibility Criteria
Inclusion
- Youth 10-17 years old and at least one parent/guardian
- 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
- Have significant intellectual disability (IQ\<70) or significant expressive or receptive language that would interfere with psychotherapy, according to parent- or youth-report
- 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
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06560736
Start Date
October 1 2024
End Date
August 31 2026
Last Update
December 23 2025
Active Locations (1)
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1
University of Missouri
Columbia, Missouri, United States, 65201