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New therapy aims to ease anxiety in teens with rare metabolic disorder
NCT ID NCT06560736
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a short-term behavioral program called Show Me FIRST to help teens with PKU manage anxiety and depression. Thirty adolescents will be randomly assigned to receive the program right away or after a wait period. The researchers will also check if new phone-based tests can accurately measure mood and thinking in daily life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Show Me FIRST coping skills intervention (behavioral therapy)
- What this could lead to
- If it works, this could provide a new, drug-free way to ease anxiety and depression in teens with PKU, improving their quality of life.
- What could go wrong
- This is a small, early-stage trial with only 30 participants, so results may not apply to everyone. The therapy may not reduce anxiety more than usual care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Missouri
RECRUITINGColumbia, Missouri, 65201, United States
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Other studies related to the condition(s) this trial covers.
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- PKU Drug's nutritional impact under the microscope
- PKU diet in childhood may shape adult IQ, study finds
- New PKU drink passes small taste and tolerance test
- New PKU formula shows promise in managing blood levels