The main research site first receives research ethics approval to be the coordinating institution and host of the registry (“host site”). The host site also prepares all ‘core’ documents: study protocol, consent/assent forms and advertisements. The study protocol must state that the project involves multiple sites and will be amended as sites join the network/are confirmed. The study protocol and consent/assent forms must state that data will be transferred to the host site for data analysis.

Each partner site must also apply for local research ethics approval utilizing the ‘core’ documents (and adapting as necessary; e.g., translating, additional local data analyses, etc.). Upon approval, the partner site must provide to the host site: the locally approved study protocol, consent/assent forms and advertisements as well as the approval certificate. It is the responsibility of the partner site to renew the study locally and to provide updated documents and certificates to the host site.

Each partner site must sign a Data Transfer Agreement with the host site, as the host site will conduct data analysis across all sites. The host site will prepare the agreement and liaise with each partner site.

Consent and assent should be obtained digitally using a web link. This simplifies the process and reduces the burden of paper forms (which have to be sent to a local site, retained for the duration of the study, managed [e.g., a lab moves offices and needs to move the papers], etc.).

If patients/families are interested in participating, they must discuss with their doctor. If a doctor is interested, they must discuss with their patients/families. When both parties agree to participate, both will sign a consent form (youth will sign an assent form) before receiving the link to the Restlessness Registry.

Each partner site will be responsible for collecting data from their communities and then transferring it to the host site. The host site will also collect local data, but additionally collect data across-the-board for communities that are not near any sites.

Families will be asked to complete the Sleep Disturbance Scale for Children [Bruni et al. 1996], the ADHD Rating Scale IV Home Version [DuPaul et al. 1995], a sitting and laying down test, and a storyboard to describe typical movement patterns with pictograms. Doctors will be asked to complete blood work/investigations of iron levels. The burning question is: how do we integrate the iron investigations in the Registry?

After completing the assessment, families and their doctors will review the results and discuss the next steps/recommendations for an intervention. After the intervention is complete, families will complete the assessment again and review the results with their doctors. This can continue in a cycle for as long as it is required.

The benefit of separating the intervention from the Restlessness Registry is that we can diversify the possible interventions and personalize them to each participant. For high-risk patients (e.g., experienced concussion(s), diagnosed with ADHD or RLS, has a psychiatric condition, etc.), patients will be invited to participate in a tier II intervention. It will be possible to integrate randomized trials and state-of-the-art diagnostic procedures and technologies. This tier II information can then be linked with the Restlessness Registry data.