NCT05671107|Completed
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · PTEN Research Foundation
observational
300
2 countries
2
Study Start
September 9, 2021
Actual (reported)Primary Completion
June 1, 2024
Actual (reported)Study Completion
June 30, 2024
Actual (reported)The purpose of this study is to develop a survey completed by parents, caregivers, or other informants that evaluates several important domains of functioning relevant to individuals with neurodevelopmental disorders, including autism spectrum disorder and people with genetic syndromes. Participation in this research will include assisting the research team in the development of the survey measures.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 9, 2021
Actual (reported)December 16, 2022
Actual (reported)January 4, 2023
Actual (reported)June 1, 2024
Actual (reported)June 30, 2024
Actual (reported)Social Communication Interaction
Develop survey questions and scales related content areas for Social Communication Interactions. Social communication refers to the emergence of verbal and nonverbal skills, social interaction, and social cognition
Baseline
Social Communication Interaction
Develop survey questions and scales related content areas for Social Communication Interactions. Social communication refers to the emergence of verbal and nonverbal skills, social interaction, and social cognition
One month follow up
Social Communication Interaction
Develop survey questions and scales related content areas for Social Communication Interactions. Social communication refers to the emergence of verbal and nonverbal skills, social interaction, and social cognition
Four month follow up
Daily Living Skills
Restrictive and Repetitive Behaviors
Baseline
Restrictive and Repetitive Behaviors
One month follow up
Restrictive and Repetitive Behaviors
Four month follow up
Anxiety
Baseline
Anxiety
One month follow up
Patients diagnosed with PTEN Hamartoma Tumor Syndrome and a neurodevelopmental disorder including but not limited to autism spectrum disorder, attention-deficit disorder / attention-deficit hyperactivity disorder, speech language disorder(s), intellectual disability, global developmental delay, oppositional defiant disorder, and / or motor or developmental disorders.
Patients diagnosed with PTEN Hamartoma Tumor Syndrome
Siblings related to patients with diagnosis of PTEN Hamartoma Tumor Syndrome
Unrelated participants with no known genetic or neurodevelopmental disorder
Online survey measuring a variety of developmental domains including anxiety, motor, daily living skills, challenging behaviors, social communication, restrictive and repetitive behaviors, ADHD, executive functioning, mood, quality of life, and sleep
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Community sample
John Carroll Univeristy
University Heights, Ohio, 44118, United States
University Hospital South Hampton
Hampton, Southampton, S016 6YD, United Kingdom
300 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2022
First Posted
January 4, 2023
Study Start
September 9, 2021
Actual (reported)PTEN Hamartoma Tumor Syndrome Pediatric Patient Registry
Develop questions and survey scales related to content areas of activities of daily living. Activities of daily living are activities related to personal care. They include bathing or showering, dressing, getting in and out of bed or a chair, walking, using the toilet, and eating.
Baseline
Daily Living Skills
Develop questions and survey scales related to content areas of activities of daily living. Activities of daily living are activities related to personal care. They include bathing or showering, dressing, getting in and out of bed or a chair, walking, using the toilet, and eating.
One month follow up
Daily Living Skills
Develop questions and survey scales related to content areas of activities of daily living. Activities of daily living are activities related to personal care. They include bathing or showering, dressing, getting in and out of bed or a chair, walking, using the toilet, and eating.
Four months later
Contact the study team to confirm eligibility.
Primary Completion
June 1, 2024
Actual (reported)Study Completion
June 30, 2024
Actual (reported)Last Updated
September 19, 2024
Record last verified: 2024-02
Plan to upload deidentified data to Open Science Framework
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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