Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

Launched by UNIVERSITY OF MISSOURI-COLUMBIA · Aug 16, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring new ways to help teenagers with Phenylketonuria (PKU) manage anxiety and depression. While most previous research has focused on medication to lower high blood phenylalanine levels (Phe), this study is looking at how a short, skills-based therapy called "Show Me FIRST" can improve mental health and overall quality of life for young people with PKU. The trial will involve 30 adolescents between the ages of 10 and 17 from Missouri, Kansas, or Illinois, who will be randomly assigned to either receive the therapy right away or join a wait-list to receive it later.

To be eligible, participants should have a formal diagnosis of PKU and must be interested in taking part in a brief therapy program designed to help with anxiety and depression. However, those with significant intellectual disabilities, plans for other therapy during the study, or active suicidal thoughts will not be included. If you or someone you know meets these criteria, participating in this trial could provide valuable support and help improve mental health for teenagers living with PKU.

Gender

ALL

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 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