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NCT06560736
Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria
NA trial testing Show Me FIRST coping skills intervention in Phenylketonurias in 30 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | University of Missouri-Columbia |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 October 2024 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 August 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Show Me FIRST coping skills intervention
Conditions studied
- Phenylketonurias — all drugs for Phenylketonurias →
Sponsor
University of Missouri-Columbia
Who can join
Adults 10 to 17, any sex, with Phenylketonurias. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06560736
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Phenylketonurias
Currently open trials in the same condition.
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- NCT06718842 — Walking Program in Fatty Liver Children With Phenylketonuria · NA · recruiting
- NCT06687733 — Safety and Efficacy Study of NGGT002 in cPKU Adult Subjects · Phase 1, PHASE2 · recruiting
- NCT06061614 — Safety and Efficacy Study of NGGT002 in PKU Adult Subjects · EARLY_PHASE1 · recruiting
- NCT05128149 — Metabolic Control and Patient Well-being in Phenylketonuria: do Guidelines Make a Difference? · recruiting
Other University of Missouri-Columbia trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06560736 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Missouri-Columbia
- Last refreshed: 23 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06560736.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing