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 Study Enrollment
Number of participants enrolled in the study, of those eligible
Time frame: Baseline
Feasibility of Intervention Attendance (% Attending at Least 6 of 8 Sessions)
Number of participants attending at least 6 of 8 group meetings (of those who attended at least 1 group session)
Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)
Feasibility of Intervention Attendance (% Attending at Least 4 of 8 Sessions)
Number of participants attending at least 4 of 8 group meetings
Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)
Feasibility of Follow-up Survey Completion
Number of participants providing follow-up surveys after group completion
Time frame: Approximately 3 months (8-10 weeks) post-enrollment
Acceptability of the Refined Intervention Content (SMART-3RP and HEP)
Number of participants rating satisfaction with intervention content as high (at least 4 on a Likert scale of 1-5), of those who attended at least one program session.
Time frame: Approximately 3 months (approximately 8-10 weeks after intervention start)
Acceptability of Number of Sessions
Number of participants rating satisfaction with number of sessions as high (at least 4 on a Likert scale of 1-5), of those completing at least one group session.
Time frame: Approximately 3 months (8-10 weeks) post-enrollment
Acceptability of Teleconferencing Delivery
Number of participants rating satisfaction with teleconferencing as high (at least 4 on a Likert scale of 1-5), of those who completed at least one program session.
Time frame: Approximately 3 months (8-10 weeks) post-enrollment
Acceptability- Group Cohesiveness
Number of participants rating agreement with within-group trust as high (at least 4 on a Likert scale of 1-5), of those who completed at least one program session.
Time frame: Approximately 3 months (8-10 weeks) post-enrollment
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