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Open Pilot Trial of a Resiliency Group Program for Caregivers of Children With Learning and Attentional Difficulties: Supporting Parents Raising Kids (SPARK)
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
MGH
Boston, Massachusetts, United States
Start Date
November 1, 2024
Primary Completion Date
March 17, 2025
Completion Date
March 17, 2025
Last Updated
March 12, 2026
28
ACTUAL participants
SMART-3RP
BEHAVIORAL
Health Education Program
BEHAVIORAL
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT07360600
NCT06170047
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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