New psychological tools and anxiety intervention for adolescents with PKU

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a short-term skills-based intervention called Show Me FIRST for treating anxiety and depression in adolescents diagnosed with phenylketonuria (PKU). A total of 30 participants aged 10-17 will be randomly assigned to either an immediate intervention group or a wait-list group. The intervention will be delivered remotely over 10 weeks, and participants will undergo psychological and neurocognitive assessments at three different time points to measure outcomes. The study also seeks to validate new assessment tools that capture real-time psychological functioning.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University of Missouri
  Columbia, Missouri, United States Recruiting

Study contacts

• Study coordinator: Shawn Christ
• Email: christse@missouri.edu
• Phone: 573-884-8140

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Effects of Palynziq on diet and health in patients with PKU

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.