Clinical Trials Directory

Trials / Completed

CompletedNCT06492278

Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties

Open Pilot Trial of a Resiliency Group Program for Caregivers of Children With Learning and Attentional Difficulties: Supporting Parents Raising Kids (SPARK)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
28 (actual)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSMART-3RPThe adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
BEHAVIORALHealth Education ProgramThis is a multiple behavior change program that addresses sleep, exercise, nutrition, substance use, and working with one's healthcare team.

Timeline

Start date
2024-11-01
Primary completion
2025-03-17
Completion
2025-03-17
First posted
2024-07-09
Last updated
2026-03-12
Results posted
2026-03-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06492278. Inclusion in this directory is not an endorsement.