Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria (NCT06560736)
Development of Novel Psychological Assessment Tools and Anxiety Intervention for PKU: Intervention Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (5 items).
Location: University of Missouri — Columbia, Missouri
Age range: 10 Years to 17 Years
🧪 Interventions in This Study
- Show Me FIRST coping skills intervention (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Missouri — Columbia, Missouri
📞 Contact the Study Coordinator
Phone: (573) 884-8140
Email: christse@missouri.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Participants will receive the 10-week Show Me First program for treatment of anxiety and depression.
More studies in Phenylketonurias
- Nutritional Impacts of Palynziq on Patients With Phenylketonuria (PKU) — Atlanta, Georgia
- AAV Gene Therapy Clinical Study in Adult Classic PKU (PHEdom) — Orange, California
Explore by condition: All Phenylketonurias clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.