Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560736
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-30
Brief Title:
Development of Novel Psychological Assessment Tools and Anxiety Intervention for Phenylketonuria
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of Novel Psychological Assessment Tools and Anxiety Intervention for PKU Intervention Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-listdelayed intervention group
Detailed Description:
A sample of 30 adolescents age 10-17 with PKU and a history of elevated anxiety andor 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 n15 or wait-listdelayed intervention group n15 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None