Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria
Recruiting
N/AInterventional Study
Phenylketonurias
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
10 – 17
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
University of Missouri-Columbia · Other
Who this trial is looking for
This trial is looking for adolescents with phenylketonuria (PKU) who want help with anxiety and depression. Participants will take part in a short skills-based program and provide feedback on new assessment tools being developed.
Are You a Good Fit for This Trial?
You may be able to join if
I am 10-17 years old
I have been diagnosed with PKU
I am interested in a program to help with anxiety and depression
I live in Missouri, Kansas, or Illinois
You may not be able to join if
I have a significant intellectual disability
I plan to receive other therapy during the study
I plan to change my current medications during the study
I have active suicidal thoughts requiring immediate treatment
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 F…
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.
Trial Locations
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Eligibility Criteria
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 rec…
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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