Supporting caregivers of children with rare neurogenetic conditions through telehealth
Optimizing a Personalized Health Approach for Virtually Treating High-risk Caregivers During COVID-19 and Beyond
This study is testing different online support programs to see which ones help caregivers of children with rare neurogenetic conditions the most.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Purdue University Academic / other |
| Locations | 1 site (West Lafayette, Indiana) |
| Trial ID | NCT05999448 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify the most effective telehealth-based support programs for caregivers of children with rare neurogenetic conditions. It will utilize a personalized health algorithm to match caregivers to appropriate digital health treatments based on their individual needs and circumstances. Participants will engage in a 12-week program that may include self-guided resources, individual and group therapies, and peer-to-peer coaching. Throughout the program, caregivers will complete questionnaires to assess their experiences and the effectiveness of the support provided.
Who should consider this trial
Good fit: Ideal candidates are caregivers or legal guardians of children aged 2-35 with a neurogenetic condition that causes moderate to severe intellectual disability.
Not a fit: Patients who may not benefit include those with serious mental illnesses or active addictions that cannot be adequately addressed through the study's treatments.
Why it matters
Potential benefit: If successful, this study could significantly improve the mental health and well-being of caregivers, enhancing their ability to support their children.
How similar studies have performed: Previous studies have shown initial feasibility and acceptability of telehealth interventions for caregivers, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Caregiver and legal guardian of child age 2-35 with neurogenetic condition * Child's syndrome must (1) have an established genetic cause, (2) affect the brain, resulting in moderate to severe intellectual disability in the majority of patients * Reside in US * Fluent in English (spoken and written) * Seeking support for caregiver mental health/well-being and/or caregiving needs Exclusion Criteria: * Serious mental illness or active addiction that would be inadequately addressed through dosage of treatments * Actively in treatment that would be redundant with those offered in the protocol * Child's syndrome is not commonly associated with (1) life expectancy less than 35 years or (2) deterioration of previously gained skills. Additional treatment-specific inclusion criteria are embedded in the experimental algorithm that will be adjusted through Aim 1.
Where this trial is running
West Lafayette, Indiana
- Purdue University — West Lafayette, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Bridgette Kelleher, PhD — Purdue University
- Study coordinator: Bridgette L Kelleher, PhD
- Email: bkelleher@purdue.edu
- Phone: 18438100238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.