Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

Part of paid clinical trials in Columbia, Missouri.

Sponsor
University of Missouri-Columbia
Study ID
NCT06560736
Status
Recruiting
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Conditions

  • Phenylketonurias

Eligibility Criteria

Sex
ALL
Age
10 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Show Me FIRST coping skills intervention — BEHAVIORAL
    Show Me FIRST is a flexible, transdiagnostic intervention organized around well-tested principles of youth psychotherapeutic change.

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Dec 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Immediate Intervention Group
  • Other: Wait List / Delayed Intervention Group

Primary Outcome Measure

PROMIS Anxiety & Depression scales [ Time Frame: Weeks 0, 11, & 22 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MissouriColumbiaMissouri65201
Shawn Christ
[email protected]
573-884-8140

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By research site
University of Missouri· Columbia, MO

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