Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

{ "Study of Show Me FIRST for Anxiety in Phenylketonuria", "This study is looking at a coping skills program called Show Me FIRST for teenagers with Phenylketonuria (PKU). PKU is a genetic condition where the body can't break down a substance called phenylalanine (Phe), which can lead to health problems. The study wants to see if this program can help reduce anxiety and depression in young people aged 10 to 17 who have PKU and have experienced these symptoms. It also aims to test new ways of measuring brain function and psychological well-being \"in the moment.\" To join, you must be 10-17 years old, have a formal diagnosis of PKU, and have received treatment for PKU within the first 30 days of life. The study is currently recruiting 30 participants.", "design": "This is an interventional study with 30 participants, where you would be randomly assigned to either receive the Show Me FIRST program right away or after a waiting period.", "commitments": "You would participate in a 10-week program and complete psychological and brain function evaluations at the start, after 11 weeks, and after 22 weeks. All activities will be done remotely through video calls and phone apps.", "compensation": "Not stated in the trial record.", "follow_up": "You will be followed for 22 weeks after the start of the study, with assessments at weeks 0, 11, and 22.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT06560736

Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

Recruiting
NAAges 10–17InterventionalTreatment
University of Missouri-Columbia
~30 participants
Updated 2025-12-23 on ClinicalTrials.gov
What's tested:Show Me FIRST coping skills intervention

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PROMIS Anxiety & Depression scales
Measured over Weeks 0, 11, & 22
+1 more outcome measured
Phenylketonurias
1 sites across 1 states
Missouri1

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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
  • PROMIS Anxiety & Depression scalesWeeks 0, 11, & 22

    Patient-reported outcome (PRO) measure of anxiety \& depression symptoms

  • Test My Brain phone-based EMA cognitive testWeeks 0, 11, & 22

    Performance-based measure of cognitive skill \& attention