Development of Novel Psychological Assessment Tools and Anxiety Intervention for PKU: Intervention Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 17
Healthy Volunteers: f
View:

• 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.

Locations
United States
Missouri
University of Missouri
RECRUITING
Columbia
Contact Information
Primary
Shawn Christ
christse@missouri.edu
573-884-8140
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 30
Treatments
Other: Immediate Intervention Group
Other: Wait List / Delayed Intervention Group
Related Therapeutic Areas
Sponsors
Leads: University of Missouri-Columbia
Collaborators: National PKU Alliance

This content was sourced from clinicaltrials.gov