New psychological tools and anxiety intervention for adolescents with PKU
Development of Novel Psychological Assessment Tools and Anxiety Intervention for PKU: Intervention Trial
This study is testing a new online program to help teenagers with PKU manage anxiety and depression better over 10 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | University of Missouri-Columbia Academic / other |
| Locations | 1 site (Columbia, Missouri) |
| Trial ID | NCT06560736 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a short-term skills-based intervention called Show Me FIRST for treating anxiety and depression in adolescents diagnosed with phenylketonuria (PKU). A total of 30 participants aged 10-17 will be randomly assigned to either an immediate intervention group or a wait-list group. The intervention will be delivered remotely over 10 weeks, and participants will undergo psychological and neurocognitive assessments at three different time points to measure outcomes. The study also seeks to validate new assessment tools that capture real-time psychological functioning.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-17 with a formal diagnosis of PKU and a history of anxiety or depression.
Not a fit: Patients with significant intellectual disabilities or those planning to receive other psychotherapy during the study may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the mental health and quality of life for adolescents with PKU.
How similar studies have performed: While previous studies have focused on pharmacological treatments for PKU, this psychosocial approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Columbia, Missouri
- University of Missouri — Columbia, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Shawn Christ
- Email: christse@missouri.edu
- Phone: 573-884-8140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.