JMIR Publications

ABSTRACT

Background:

Even prior to the COVID-19 pandemic, caregivers of children with rare neurogenetic conditions (NGC) experienced elevated physical and mental health challenges; these challenges further escalated during COVID-19 due to crisis-level breakdowns in support and intervention services. Telehealth mental health and parenting support services expanded rapidly in response to the COVID-19 pandemic and may be well-suited to facilitate necessary support interventions for parents of children with NGCs. However, it remains unclear how to match these evidence-based interventions to individual NGC caregivers’ needs.

Objective:

Project WellCAST (Addressing the WELLbeing of CAregiverS via Telehealth; NCT05999448) is an early-phase clinical trial designed to prospectively test which evidence-based telehealth interventions best meet the needs of NGC caregivers. Specifically, we develop and optimize a personalized health algorithm that matches caregivers to specific evidence-based telehealth support programs; we then test the feasibility and efficacy of algorithm-assigned treatment across four waves of data collection, relative to quasi-random assignment and waitlist controls. During each treatment wave, the personalized health algorithm relies on two weeks of baseline data collection using clinical tools and innovative smartphone-based ecological momentary assessments (EMA). Across waves, we also test the efficacy of a motivational peer-to-peer coaching protocol, deployed by trained NGC caregiver staff, in enhancing treatment uptake and clinical outcomes.

Methods:

Interested and eligible NGC caregivers are enrolled into a 24-week program with five phases, including baseline (2 weeks), treatment (12 weeks), and follow-up (2 weeks) periods; 4 week gaps separate phases. Caregivers participate in two randomizations: (1) treatment assignment via a precision health algorithm versus quasi-random assignment, and (2) motivational coaching by another NGC caregiver and project staff member (“peer coaching”) versus standard check-ins by a staff member who is not a NGC caregiver (“staff coaching”). Treatments include Acceptance and Commitment Therapy, Dialectical and Behavioral Therapy, Culturally-Informed Cognitive-Behavioral Therapy, Research Units in Behavioral Intervention, Naturalistic Communication Intervention, Durand Sleep Intervention, and self-guided resources. A subset of caregivers will participate as waitlist controls prior to treatment.

Results:

Four waves of data collection are scheduled for August 2023-September 2025. Pre-registered analyses will contrast feasibility, efficacy, and acceptability across algorithms and coaching assignment; multiple waves of data collection will allow us to continually optimize the algorithm and test incremental improvements across project phases. Secondary analyses will probe the feasibility and efficacy of individual evidence-based treatments and peer coaching.

Conclusions:

Project WellCAST will test whether a digital personalized health algorithm and peer coaching protocol can prospectively enhance telehealth treatment outcomes among NGC caregivers. This project is relevant to the specific population of NGC caregivers and may also inform how brief digital assessments, precision health tools, and community-academic partnerships can enhance public heath response to mental health crises across other high-need populations. Clinical Trial: NCT05999448; https://osf.io/8wndp