Recruiting

Anxiety Intervention

Sponsor:

University of Missouri-Columbia

Code:

NCT06560736

Conditions

Phenylketonurias

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

Interventions

Show Me FIRST coping skills intervention

Study Details

Brief summary:

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.

Conditions

Phenylketonurias

Study ID

NCT06560736

Start date

Oct 1, 2024

Status verified date

Dec, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Immediate Intervention Group

other: Wait List / Delayed Intervention Group

Interventions

Show Me FIRST coping skills intervention

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

Primary outcome measure

  • PROMIS Anxiety & Depression scales [ Time Frame: Weeks 0, 11, & 22 ]
  • Test My Brain phone-based EMA cognitive test [ Time Frame: Weeks 0, 11, & 22 ]

Central Contacts and Locations

Central contacts

Shawn Christ

573-884-8140christse@missouri.edu

Locations

University of Missouri

Recruiting

Columbia, Missouri, United States, 65201

Contacts

Shawn Christ

573-884-8140christse@missouri.edu

More Information

Sponsor

University of Missouri-Columbia

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Missouri-Columbia on 2025-12-23.