Phoenix Children's Hospital
The goal of this clinical trial is to test and improve an online program for caregivers of young children with spina bifida. Investigators hope to learn whether the program can improve caregiver stress and positive parenting behaviors during early childhood. In the preliminary phase of this clinical trial, investigators are aiming to answer these questions: 1. Are caregivers of young children with spina bifida willing to participate in the program and complete assessments before and after the program? 2. Do caregivers rate the program as easy to use and helpful? 3. How can the program be improved in the future? 4. Does the program result in clinically meaningful reductions in caregivers' stress and increase caregivers' use of positive parenting strategies? Caregivers of young children with spina bifida who agree to participate will complete surveys when they begin the study and a videotaped interaction task playing with their child. Children will complete a brief developmental test. Caregivers will then complete the program, involving completing 6 weekly online modules that are paired with a 1-hour group meeting with other caregivers. Sessions will focus on helping caregivers connect with others who have a young child with spina bifida, as well as helping families cope with stress and support early child development. Caregivers will repeat the surveys and videotaped interaction task again three months later, after the program is completed, and again six months later. They will also be invited to participate in an interview to learn about their experience in the program.
This study will involve rapid-cycle testing of the program with 10 caregivers of young children with spina bifida to examine usability, feasibility, acceptability, and proof-of-concept (i.e., clinically meaningful change for individual families) to refine the intervention and implementation plan. Rapid-cycle testing will determine the program's optimal duration and format. This will be completed in partnership with advisory boards comprised of 10 caregivers of children with spina bifida and 10 healthcare providers ("co-designers"), with an emphasis on families from low-income and rural backgro…
Inclusion Criteria for the Caregiver: * Caregiver is the parent or legal guardian of the child * Caregiver lives with the child at least 50% of the time * Caregiver is fluent in English Inclusion Criteria for the Child with Spina Bifida: * Child has Spina Bifida (e.g., myelomeningocele, meningocele, lipomyelomeningocele) * Child is between the ages of 2.5 and 6 years old, but no older than 6.5 years old at study enrollment Exclusion Criteria: * Not applicable
The digital health intervention is based on the Parent Acceptance and Commitment Therapy (PACT) and positive parenting literature. Caregivers in the program will complete 6 self-directed online modules that are paired with group sessions, where caregivers can meet others who have a child with spina bifida and discuss how to use what they learned in the modules in daily life.