University of Missouri
Columbia, Missouri, 65201, United States
Location status: Recruiting
NCT Number: NCT06560736
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.
Interested in participating?
Request Info10 year–17 year
All sexes
Interventional
Not applicable
Columbia, Missouri, 65201, United States
Location status: Recruiting
A sample of 30 adolescents (age 10-17) with PKU and a history of elevated anxiety and/or depression symptomatology will be recruited to participate in a randomized control trial. Following screening and informed consent, participants will be randomized to an immediate intervention group (n=15) or wait-list/delayed intervention group (n=15). Participants will receive the 10-week Show Me First program for treatment of anxiety and depression. Participants will complete extensive psychological and neurocognitive evaluations at three timepoints: Weeks 0, 11, and 22. The assessments and intervention will all be administered remotely via secure videoconference and cell-phone based applications.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Show Me FIRST is a flexible, transdiagnostic intervention organized around well-tested principles of youth psychotherapeutic change.
Time frame: Weeks 0, 11, & 22
Patient-reported outcome (PRO) measure of anxiety & depression symptoms
Time frame: Weeks 0, 11, & 22
Performance-based measure of cognitive skill & attention
Time frame: Weeks 0, 11, & 22
Patient-reported outcome (PRO) measure of everyday symptoms of executive problems
Time frame: Weeks 0, 5, 11, 16, & 22
Time frame: Weeks 0, 11, & 22
Patient-reported outcome (PRO) measure of ADHD symptoms
Time frame: Weeks 0, 11, & 22
Patient-reported outcome (PRO) measure of cognitive symptoms
Time frame: Weeks 0, 11, & 22
Performance-based measure of memory & learning
Time frame: Weeks 0, 11, & 22
Performance-based measure of inhibitory ability
Time frame: Weeks 0, 11, & 22
Patient-reported outcome (PRO) measure of anxiety & depression symptoms
Time frame: Weeks 0, 11, & 22
Patient-reported outcome (PRO) measure of internalizing & externalizing problems
Time frame: Weeks 0, 11, & 22
Patient-reported outcome (PRO) measure of sleep problems
Time frame: Weeks 0, 11, & 22
Patient-reported outcome (PRO) measure of overall symptom severity and improvement
Contact information is provided by the study sponsor or research team.
University of Missouri-Columbia
Other
Development of Novel Psychological Assessment Tools and Anxiety Intervention for PKU: Intervention Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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