This is a randomized open pilot trial enrolling up to 40 co-primary caregivers of children with LAD. Participants will be randomized to receive either mind-body resiliency group (SMART-LAD, intervention) or an evidence-based group intervention Health Education Program (HEP, control) which is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team. Both the SMART-3RP and HEP programs have been modified based on adaptions from our previous qualitative study.
The primary objective of this protocol is to conduct an open pilot to elicit initial quantitative and qualitative feedback regarding feasibility and acceptability of the interventions (SMART-3RP and HEP) that we have refined. Both groups are designed to improve well-being for caregivers experiencing stress-related to caring for a child with LAD. The investigators will ask participants to complete approximately 15-minute survey batteries via REDCap at baseline and after the 8-week program, including assessments of intervention feasibility and acceptability as well as psychosocial outcomes. To inform plans for ongoing program refinement, the investigators will also elicit specific feedback regarding study assessment tools, recruitment procedures, and group composition. Results will be used to inform a larger randomized trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
This is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team.
MGH
Boston, Massachusetts, United States
Feasibility of the refined interventions (SMART-3RP and HEP)
Rates of intervention attendance (# of sessions), rates of participant recruitment (%) enrollment, survey completion rates (%).
Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)
Acceptability of the refined interventions (SMART-3RP and HEP)
Likert ratings of group comfort and cohesiveness.
Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.