Social Support and Stress Reduction for Caregivers of Young Adults With IDD (CareWell)
Primary Purpose
Burden, Caregiver
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga; Support Group
Sponsored by
About this trial
This is an interventional supportive care trial for Burden, Caregiver focused on measuring Caregiver, Down syndrome, Intellectual Disability, Parent, Stress
Eligibility Criteria
Inclusion Criteria: 1) caregiver of a young adult with IDD 2) self-reported ability to participate in a yoga class with no contraindications to participation. Exclusion Criteria: 1) Actively participating in another health lifestyles interventional research study.
Sites / Locations
- University of Kansas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Social Support and Yoga
Arm Description
This is a single arm trial. This arm includes one hour of a guided social support group and one hour of yoga, weekly for 12 total weeks.
Outcomes
Primary Outcome Measures
Recruitment
We will calculate recruitment rate by dividing the number of participants who enroll by those who were found eligible on the questionnaire.
Session Attendance
The group session leaders will record attendance at weekly sessions. The participants will only be considered present if they complete the entire 2-hour session. The outcome variable will be the number of sessions attended (count) and percentage of attendance out of the total 12 scheduled sessions.
Retention
Calculated as percentage of participants who completed the out of those who enrolled
Acceptability
Semi-structured interviews will be conducted with each caregiver to assess satisfaction with the intervention components. Interviews will be recorded and transcribed for analysis.
Secondary Outcome Measures
The Perceived Stress Scale
The Perceived Stress Scale will be administered at baseline and post intervention. Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.
ug/dL Salivary cortisol
Cortisol will be used of measure physiologic stress collected at baseline and post intervention, self-collected using saliva swabs. Test kits can detect salivary cortisol in the range between 0.012-3.000 ug/dL.
The Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS) will be given at baseline and post intervention. This measure scores from 12-84 with the higher score indicating more perceived support.
Modified Caregiver Strain Index
Modified Caregiver Strain Index will be given to participants at baseline and post intervention. Scoring ranges from 26 to 0; a higher score indicates a higher level of caregiver strain.
The Family Empowerment Scale
The Family Empowerment Scale, only subscales family and service systems will be administered, at baseline and 12 weeks. Each subscale scores from 0-60, with a higher score indicating better family empowerment.
The Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index will be administered at baseline and post intervention. Overall scores range from 0 to 21, where lower scores denote a healthier sleep quality.
Full Information
NCT ID
NCT05938998
First Posted
June 29, 2023
Last Updated
July 6, 2023
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05938998
Brief Title
Social Support and Stress Reduction for Caregivers of Young Adults With IDD
Acronym
CareWell
Official Title
Social Support and Stress Reduction for Caregivers of Young Adults With IDD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to evaluate the feasibility and stress reduction impacts of a yoga and support group intervention on caregivers of individuals with intellectual and developmental disabilities.
Detailed Description
This is a single arm longitudinal trial. We will recruit up to 40 caregivers of young adults with intellectual and developmental disabilities (IDD). This is a 12-week social support, resources, and stress reduction intervention delivered in person to a group of caregivers of young adults IDD. Participants will be asked to attend one 2 hour group session each week. All sessions will have a 1-hour discussion on resources and social support and 1-hour of yoga. All yoga sessions will be taught by 200 Registered Yoga Teacher certified instructors. Outcome assessments will be collected at baseline and after the 12-week intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burden, Caregiver
Keywords
Caregiver, Down syndrome, Intellectual Disability, Parent, Stress
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Social Support and Yoga
Arm Type
Experimental
Arm Description
This is a single arm trial. This arm includes one hour of a guided social support group and one hour of yoga, weekly for 12 total weeks.
Intervention Type
Behavioral
Intervention Name(s)
Yoga; Support Group
Intervention Description
BEHAVIORAL: Group Exercise Sessions- Yoga. BEHAVIORAL: Social Support Sessions
Primary Outcome Measure Information:
Title
Recruitment
Description
We will calculate recruitment rate by dividing the number of participants who enroll by those who were found eligible on the questionnaire.
Time Frame
Baseline
Title
Session Attendance
Description
The group session leaders will record attendance at weekly sessions. The participants will only be considered present if they complete the entire 2-hour session. The outcome variable will be the number of sessions attended (count) and percentage of attendance out of the total 12 scheduled sessions.
Time Frame
Weeks 1-12 of intervention
Title
Retention
Description
Calculated as percentage of participants who completed the out of those who enrolled
Time Frame
Weeks 1-12 of intervention
Title
Acceptability
Description
Semi-structured interviews will be conducted with each caregiver to assess satisfaction with the intervention components. Interviews will be recorded and transcribed for analysis.
Time Frame
Between Weeks 12-14
Secondary Outcome Measure Information:
Title
The Perceived Stress Scale
Description
The Perceived Stress Scale will be administered at baseline and post intervention. Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
Change from baseline to 12 weeks
Title
ug/dL Salivary cortisol
Description
Cortisol will be used of measure physiologic stress collected at baseline and post intervention, self-collected using saliva swabs. Test kits can detect salivary cortisol in the range between 0.012-3.000 ug/dL.
Time Frame
Change from baseline to 12 weeks
Title
The Multidimensional Scale of Perceived Social Support (MSPSS)
Description
The Multidimensional Scale of Perceived Social Support (MSPSS) will be given at baseline and post intervention. This measure scores from 12-84 with the higher score indicating more perceived support.
Time Frame
Change from baseline to 12 weeks
Title
Modified Caregiver Strain Index
Description
Modified Caregiver Strain Index will be given to participants at baseline and post intervention. Scoring ranges from 26 to 0; a higher score indicates a higher level of caregiver strain.
Time Frame
Change from baseline to 12 weeks
Title
The Family Empowerment Scale
Description
The Family Empowerment Scale, only subscales family and service systems will be administered, at baseline and 12 weeks. Each subscale scores from 0-60, with a higher score indicating better family empowerment.
Time Frame
Change from baseline to 12 weeks
Title
The Pittsburgh Sleep Quality Index
Description
The Pittsburgh Sleep Quality Index will be administered at baseline and post intervention. Overall scores range from 0 to 21, where lower scores denote a healthier sleep quality.
Time Frame
Change from baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1) caregiver of a young adult with IDD 2) self-reported ability to participate in a yoga class with no contraindications to participation.
Exclusion Criteria:
1) Actively participating in another health lifestyles interventional research study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Bodde, PhD
Phone
9135887983
Email
abodde@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bethany Forseth, PhD
Phone
9135887983
Email
bhanson4@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Bodde, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Bodde, PhD
Email
abodde@kumc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Social Support and Stress Reduction for Caregivers of Young Adults With IDD
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