Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492278
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-27
Brief Title:
Resiliency Programming for Caregivers of Children With Learning and Attentional Difficulties
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Open Pilot Trial of a Resiliency Group Program for Caregivers of Children With Learning and Attentional Difficulties Supporting Parents Raising Kids SPARK
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARK
Brief 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 ones 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R56AT011869-01A1 | NIH | None | None |