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New treatment option for Phenylketonurias
Official title Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria
ClinicalTrials.gov ID: NCT06560736
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- 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...
- Interest in receiving a brief, psychotherapeutic skills program to prevent and treat symptoms of anxiety and/or depression, according to parent- and...
- Located in Missouri, Kansas, or Illinois.
You likely can't join if
- Have significant intellectual disability (IQ\<70) or significant expressive or receptive language that would interfere with psychotherapy, according...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Columbia, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Columbia, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.