RECRUITING

Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-01
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06560736

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Youth 10-17 years old and at least one parent/guardian
  2. * 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.
  3. * Interest in receiving a brief, psychotherapeutic skills program to prevent and treat symptoms of anxiety and/or depression, according to parent- and youth-report
  4. * Located in Missouri, Kansas, or Illinois.
  1. * Have significant intellectual disability (IQ\<70) or significant expressive or receptive language that would interfere with psychotherapy, according to parent- or youth-report
  2. * Plans to receive non-study psychotherapy during the course of study participation, according to parent- or youth-report
  3. * Plans to change current psychoactive or PKU-related medication during the course of study participation, according to parent- or youth-report
  4. * Have active suicidal ideation that would necessitate immediate treatment or require higher level of care than brief psychotherapy, according to parent- or youth-report

Contacts and Locations

Study Contact

Shawn Christ
CONTACT
573-884-8140
christse@missouri.edu

Study Locations (Sites)

University of Missouri
Columbia, Missouri, 65201
United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Phenylketonurias