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Behavioral Intervention

Coping Skills Intervention for Phenylketonuria

N/A
Recruiting
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 0, 11, & 22
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to study the effectiveness of a short-term psychosocial therapy called Show Me FIRST for treating anxiety and depression in adolescents with PKU. The researchers also want to validate new assessment measures that

Who is the study for?
This trial is for youths aged 10-17 with Phenylketonuria (PKU), and their guardians, who are interested in a psychotherapeutic program to manage anxiety or depression. Participants must be from Missouri, Kansas, or Illinois and have been diagnosed with PKU at birth with treatment starting within the first month of life.
What is being tested?
The study tests 'Show Me FIRST', a short-term intervention aimed at reducing anxiety and depression in adolescents with PKU. It also evaluates new psychological assessment tools using real-time data collection on cognitive and emotional states.
What are the potential side effects?
Since this is a psychological intervention focusing on coping skills, there may not be physical side effects like those seen with medication. However, participants might experience emotional discomfort when discussing personal issues during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was diagnosed with PKU at birth and started treatment within the first month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 0, 11, & 22
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 0, 11, & 22 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PROMIS Anxiety & Depression scales
Test My Brain phone-based EMA cognitive test
Secondary study objectives
ADHD Rating Scale - 4th version (ADHD-RS-IV)
Adolescent Insomnia Questionnaire (AIQ)
Behavior & Feelings Survey (BFS)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Wait List / Delayed Intervention GroupExperimental Treatment1 Intervention
Group II: Immediate Intervention GroupExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

National PKU AllianceUNKNOWN
2 Previous Clinical Trials
19 Total Patients Enrolled
University of Missouri-ColumbiaLead Sponsor
381 Previous Clinical Trials
628,782 Total Patients Enrolled
~20 spots leftby Aug 2026
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