RecruitingNot ApplicableNCT06560736

Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

Development of Novel Psychological Assessment Tools and Anxiety Intervention for PKU: Intervention Trial


Sponsor

University of Missouri-Columbia

Enrollment

30 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study develops and tests new psychological assessment tools and a brief anxiety-reduction therapy program specifically designed for young people aged 10–17 who have phenylketonuria (PKU), a metabolic condition requiring a strict lifelong diet, and who experience anxiety or depression. **You may be eligible if...** - You are a young person aged 10–17 with a confirmed PKU diagnosis, along with at least one parent or guardian - You were identified through newborn screening with a high phenylalanine blood level and started treatment within 30 days of birth - You or your parent reports interest in a short therapy program for anxiety or depression - You live in Missouri, Kansas, or Illinois **You may NOT be eligible if...** - You have a significant intellectual disability or language difficulties that would prevent therapy participation - You plan to receive other psychotherapy during the study - You plan to change your psychiatric or PKU medications during the study - You have active thoughts of suicide requiring immediate treatment Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALShow Me FIRST coping skills intervention

Show Me FIRST is a flexible, transdiagnostic intervention organized around well-tested principles of youth psychotherapeutic change.


Locations(1)

University of Missouri

Columbia, Missouri, United States

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NCT06560736


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