Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548022
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-29
Brief Title:
Rare Group Problem Management
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rare Group Problem Management Plus
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Participants are being asked to be in the study if they are the parent or legal guardian of a child 1 year or 18 years old with a rare condition
The group based psychoeducational intervention is called Rare Group Problem Management Plus
Rare Group PM Plus may help adults with practical and emotional problems It is a group program there will be other men or women with similar problems It happens once a week for 5 weeks each session lasts 90 minutes
Participants will complete assessments before they start Rare Group PM Participants will also complete the same assessments within a few weeks of completing Rare Group PM Assessments should only take one hour
Study visits are by Telemedicine Participants will need a smart phone or tablet If they do not have a smart phone or tablet the study team will help with this
Participants will not receive any materials or money or medication
The group based psychoeducational intervention is called Rare Group Problem Management Plus
Rare Group PM Plus may help adults with practical and emotional problems It is a group program there will be other men or women with similar problems It happens once a week for 5 weeks each session lasts 90 minutes
Participants will complete assessments before they start Rare Group PM Participants will also complete the same assessments within a few weeks of completing Rare Group PM Assessments should only take one hour
Study visits are by Telemedicine Participants will need a smart phone or tablet If they do not have a smart phone or tablet the study team will help with this
Participants will not receive any materials or money or medication
Detailed Description:
Participants are being asked to be in the study because they are the parent or legal guardian of a child infancy up to 21 years old with a rare condition
The group based psychoeducational intervention is called Rare Group Problem Management PM Plus intervention
Rare Group PM Plus may help adults with practical and emotional problems It is a group program there will be other men or women with similar problems It happens once a week for 5 weeks each session lasts 90 minutes
Investigators will be recruiting for 3 groups of 10 families each for a total of 30 families who will participate in this study from Childrens National Hospital
There are 7 study visits
Study Timeline
Study visit 1 Assessment-Before Group PM Study visit 2 Session 1-Managing Stress Study visit 3 Session 2-Managing Problems Study visit 4 Session 3-Get Going Keep Doing Study visit 5 Session 4-Strengthening Social Support Study Visit 6 Session 5-Staying Well and Looking Forward Study Visit 7 Assessment within 2 weeks after complete Group PM
Sessions will occur over Zoom Telehealth and facilitated by a licensed clinical psychologist and a genetic counselor trainee
Investigators will use chi-square tests and Fishers exact test to measure changes from baseline to 2 weeks post-intervention We will also collect qualitative data on what participants liked about the intervention what they did not like and what they think will improve the intervention
The group based psychoeducational intervention is called Rare Group Problem Management PM Plus intervention
Rare Group PM Plus may help adults with practical and emotional problems It is a group program there will be other men or women with similar problems It happens once a week for 5 weeks each session lasts 90 minutes
Investigators will be recruiting for 3 groups of 10 families each for a total of 30 families who will participate in this study from Childrens National Hospital
There are 7 study visits
Study Timeline
Study visit 1 Assessment-Before Group PM Study visit 2 Session 1-Managing Stress Study visit 3 Session 2-Managing Problems Study visit 4 Session 3-Get Going Keep Doing Study visit 5 Session 4-Strengthening Social Support Study Visit 6 Session 5-Staying Well and Looking Forward Study Visit 7 Assessment within 2 weeks after complete Group PM
Sessions will occur over Zoom Telehealth and facilitated by a licensed clinical psychologist and a genetic counselor trainee
Investigators will use chi-square tests and Fishers exact test to measure changes from baseline to 2 weeks post-intervention We will also collect qualitative data on what participants liked about the intervention what they did not like and what they think will improve the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None