Angelman Syndrome Video Assessment (ASVA) Source Material Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05637697

Acronym

ASVA SMS

Enrollment

Registered

2022-12-05

Start date

2021-08-31

Completion date

2023-08-01

Last updated

2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angelman Syndrome

Keywords

Angelman Syndrome

Brief summary

This is a longitudinal, observational, nonrandomized, fully remote study enrolling approximately 55 participant-caregiver dyads. The study includes no treatments or interventions, and participants will not be asked to change their current treatments. The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Caregiver reports that the individual with AS has a laboratory-confirmed diagnosis of Angelman syndrome * Individual with AS is at least 1 year old * Caregiver is willing and able to provide informed consent for themselves and oversee study participation * Caregiver or legal guardian is willing to provide informed consent on behalf of the individual with AS * Caregiver is comfortable reading and speaking in English * Caregiver has access to a smartphone or tablet that is compatible with the study app OR caregiver has internet access and is willing to use a wi-fi only device to record and upload videos NT-Caregiver dyads will be eligible for inclusion if the: * Neurotypical individual is between 1 and 8 years of age * Caregiver is willing and able to provide informed consent and oversee study participation and NT individual is willing and able to provide assent, as applicable * Caregiver is comfortable reading and speaking in English * Caregiver has access to a smartphone or tablet that is compatible with the study app OR caregiver has internet access and is willing to use a wi-fi only device to record and upload videos Participant-Caregiver dyads will be excluded from the study only if they do not meet the inclusion criteria above.

Design outcomes

Primary

Measure	Time frame	Description
Source material collection, Baseline	Baseline	The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system.
Source material collection, Week 12	Week 12	The objective of this study is to gather sufficient source material videos to develop a scoring system for ASVA and to perform preliminary validation of that scoring system.

Countries

United States

Outcome results