The Inchstone Project: Assessment of development and meaningful change

The developmental functioning of children with autism and other developmental challenges, especially those in the severe to profound range, are often not well captured by traditional assessment tools. This online survey research study focuses on understanding and improving measurement of development and behavior, especially for those who are the most profoundly impacted and has two main goals: 1) testing and developing assessment tools that can measure meaningful change in clinical trials and clinical practice, and 2) Incorporating parent and caregiver perspective into measure development to ensure family priorities and patient experience are at the forefront of measurement.

Eligibility Criteria

We are inviting caregivers of individuals 12 months or older who have:

1. Global developmental delay OR Intellectual disability

AND

2. Confirmed genetic condition or Epilepsy

Exclusion criteria: If a traumatic brain injury after the first month of life is considered responsible for the condition

Caregivers will complete online measures of their loved one’s medical status, development, behavior, and quality of life. We are also very interested in health economics and the impact of caregiving on family functioning. The study takes approximately 2-2 1/2 hours, but families do not have to complete the measures all at the same time. Caregivers are able to log in an out as needed, and can complete the forms when it best fits their schedule. This is a longitudinal study, so we are asking families to complete the survey once a year for 5 years. However, families do not have to complete the survey every year to be part of the study.

The information that we gather will help shape measurement in clinical trials and clinical practice for individuals with autism and developmental challenges, especially those who are the most profoundly impacted. With the potential of precision medicine and gene therapy that may have the ability to impact neurodevelopmental symptoms, we need assessment tools that are able to capture the baseline functioning of individuals and meaningful change that occurs in response to an intervention. Without adequate tools, clinical trials may not capture change that is actually occurring.

We will provide summary reports of the data for conditions with 20 or more members. We are also willing to share data with interested researchers and family groups with ethics approval.